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Trial Outcomes & Findings for Bone in CKD Alkali Response (BICARb Pilot Trial) (NCT NCT05918029)

NCT ID: NCT05918029

Last Updated: 2026-07-28

Results Overview

Change in total volumetric BMD will be analyzed by high resolution peripheral quantitative computed tomography (HR-pQCT). The 6-month absolute and relative (percent) changes in Z-score in distal radius total volumetric BMD will summarized by study arm and analyzed for between group treatment changes.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

6 participants

Primary outcome timeframe

Baseline to 6 months

Results posted on

2026-07-28

Participant Flow

Seven (7) patients were consented and six (6) of these patients were formally enrolled into the study following completion of the screening visit (Visit 1). Four (4) of the six (6) patients completed Visit 2 and were eligible to start the Run-in Period (Visit 3). Two participants completed Visit 3; however, the study was terminated as one of the patients was in the washout period. Only one (1) patient was randomized into the study (placebo arm) at the time of study termination.

Participant milestones

Participant milestones
Measure
Run-in Period, Then Potassium Citrate
Participants who completed the Run-in phase and were randomized into the Potassium Citrate arm. Potassium Citrate extended-release tablets 30 mEq twice daily. 1 mEq/kg/day divided into two doses for children to a maximum dose of 30 mEq twice daily. OR (for children who cannot take pills): Potassium citrate and citric acid for oral solution 1 mEq/kg/day divided into two doses to a maximum dose of 30 mEq twice daily Potassium Citrate Extended Release Oral Tablet: Oral potassium citrate extended-release tablet Potassium Citrate and Citric Acid Oral Solution: Oral potassium citrate and citric acid
Run-in Period, Then Placebo
Participants who completed the Run-in phase and were randomized into the Placebo arm. The single (pediatric) participant was administered 20 mEq of potassium citrate (K-citrate) twice daily, orally, at the end of the run-in period. No adult participants were part of this arm/group. Placebo: Placebo capsules identical to active ingredient.
Run-In Period Only
During the run-in phase (\~4-6 weeks), all participants received Potassium Citrate. Adult participants received K-citrate with a maximum dose of 60 mEq/d. All of the participants were on 10 mEq per tablet, one tablet, twice daily, at the end of the run-in period or at study termination.
Visit 3, Run-in Phase (4-6 Weeks)
STARTED
0
1
3
Visit 3, Run-in Phase (4-6 Weeks)
COMPLETED
0
1
1
Visit 3, Run-in Phase (4-6 Weeks)
NOT COMPLETED
0
0
2
Washout Period (2 Weeks)
STARTED
0
1
1
Washout Period (2 Weeks)
COMPLETED
0
1
0
Washout Period (2 Weeks)
NOT COMPLETED
0
0
1
Randomization Period
STARTED
0
1
0
Randomization Period
COMPLETED
0
0
0
Randomization Period
NOT COMPLETED
0
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Run-in Period, Then Potassium Citrate
Participants who completed the Run-in phase and were randomized into the Potassium Citrate arm. Potassium Citrate extended-release tablets 30 mEq twice daily. 1 mEq/kg/day divided into two doses for children to a maximum dose of 30 mEq twice daily. OR (for children who cannot take pills): Potassium citrate and citric acid for oral solution 1 mEq/kg/day divided into two doses to a maximum dose of 30 mEq twice daily Potassium Citrate Extended Release Oral Tablet: Oral potassium citrate extended-release tablet Potassium Citrate and Citric Acid Oral Solution: Oral potassium citrate and citric acid
Run-in Period, Then Placebo
Participants who completed the Run-in phase and were randomized into the Placebo arm. The single (pediatric) participant was administered 20 mEq of potassium citrate (K-citrate) twice daily, orally, at the end of the run-in period. No adult participants were part of this arm/group. Placebo: Placebo capsules identical to active ingredient.
Run-In Period Only
During the run-in phase (\~4-6 weeks), all participants received Potassium Citrate. Adult participants received K-citrate with a maximum dose of 60 mEq/d. All of the participants were on 10 mEq per tablet, one tablet, twice daily, at the end of the run-in period or at study termination.
Visit 3, Run-in Phase (4-6 Weeks)
Study Terminated
0
0
2
Washout Period (2 Weeks)
Study Terminated
0
0
1
Randomization Period
Study Terminated
0
1
0

Baseline Characteristics

None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Run-in Period, Then Potassium Citrate
Participants who completed the Run-in phase and were randomized into the Potassium Citrate arm. Potassium Citrate extended-release tablets 30 mEq twice daily. 1 mEq/kg/day divided into two doses for children to a maximum dose of 30 mEq twice daily. OR (for children who cannot take pills): Potassium citrate and citric acid for oral solution 1 mEq/kg/day divided into two doses to a maximum dose of 30 mEq twice daily Potassium Citrate Extended Release Oral Tablet: Oral potassium citrate extended-release tablet Potassium Citrate and Citric Acid Oral Solution: Oral potassium citrate and citric acid
Run-in Period, Then Placebo
n=1 Participants
Participants who completed the Run-in phase and were randomized into the Placebo arm. Placebo: Placebo capsules identical to active ingredient.
Pre-Randomization Group
n=5 Participants
Patients who were not randomized into the study.
Total
n=6 Participants
Total of all reporting groups
Chronic Kidney Disease (CKD) Etiology - Adult Participants
Tubulointerstitial
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Age, Categorical
<=18 years
—
1 Participants
n=1 Participants
0 Participants
n=5 Participants
1 Participants
n=6 Participants
Age, Categorical
Between 18 and 65 years
—
0 Participants
n=1 Participants
2 Participants
n=5 Participants
2 Participants
n=6 Participants
Age, Categorical
>=65 years
—
0 Participants
n=1 Participants
3 Participants
n=5 Participants
3 Participants
n=6 Participants
Age, Continuous
—
16 years
STANDARD_DEVIATION 0 • n=1 Participants
61.0 years
STANDARD_DEVIATION 25.7 • n=5 Participants
58.0 years
STANDARD_DEVIATION 23.0 • n=6 Participants
Sex: Female, Male
Female
—
1 Participants
n=1 Participants
2 Participants
n=5 Participants
3 Participants
n=6 Participants
Sex: Female, Male
Male
—
0 Participants
n=1 Participants
3 Participants
n=5 Participants
3 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
—
0 Participants
n=1 Participants
0 Participants
n=5 Participants
0 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
—
1 Participants
n=1 Participants
5 Participants
n=5 Participants
6 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
—
0 Participants
n=1 Participants
0 Participants
n=5 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
—
0 Participants
n=1 Participants
0 Participants
n=5 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
Asian
—
0 Participants
n=1 Participants
0 Participants
n=5 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
—
0 Participants
n=1 Participants
0 Participants
n=5 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
Black or African American
—
0 Participants
n=1 Participants
5 Participants
n=5 Participants
5 Participants
n=6 Participants
Race (NIH/OMB)
White
—
1 Participants
n=1 Participants
0 Participants
n=5 Participants
1 Participants
n=6 Participants
Race (NIH/OMB)
More than one race
—
0 Participants
n=1 Participants
0 Participants
n=5 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
Unknown or Not Reported
—
0 Participants
n=1 Participants
0 Participants
n=5 Participants
0 Participants
n=6 Participants
Region of Enrollment
United States
—
1 participants
n=1 Participants
5 participants
n=5 Participants
6 participants
n=6 Participants
Sex - Adult Participants
Male
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
3 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
3 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Sex - Adult Participants
Female
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
2 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
2 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Sex - Pediatric Participants
Male
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Sex - Pediatric Participants
Female
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
1 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
1 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Race - Adult Participants
American Indian/Alaska Native
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Race - Adult Participants
White
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Race - Adult Participants
Asian
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Race - Adult Participants
Native Hawaiian or Other Pacific Islander
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Race - Adult Participants
Black or African American
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
5 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
5 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Race - Adult Participants
Other
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Race - Adult Participants
Unknown or not reported
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Race - Pediatric Participants
American Indian/Alaska Native
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Race - Pediatric Participants
White
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
1 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
1 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Race - Pediatric Participants
Asian
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Race - Pediatric Participants
Native Hawaiian or Other Pacific Islander
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Race - Pediatric Participants
Black or African American
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Race - Pediatric Participants
Other
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Race - Pediatric Participants
Unknown or not reported
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Ethnicity - Adult Participants
Hispanic
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Ethnicity - Adult Participants
Not Hispanic
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
5 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
5 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Ethnicity - Pediatric Participants
Hispanic
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Ethnicity - Pediatric Participants
Not Hispanic
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
1 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
1 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Chronic Kidney Disease (CKD) Etiology - Adult Participants
Diabetic Nephropathy
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
2 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
2 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Chronic Kidney Disease (CKD) Etiology - Adult Participants
Hypertensive Nephropathy
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
1 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
1 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Chronic Kidney Disease (CKD) Etiology - Adult Participants
Glomerulonephritis/Nephrosis
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Chronic Kidney Disease (CKD) Etiology - Adult Participants
Congenital Anomalies of the Kidney and Urinary Tract (CAKUT)
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Chronic Kidney Disease (CKD) Etiology - Adult Participants
Glomerular
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Chronic Kidney Disease (CKD) Etiology - Adult Participants
Other (Unspecified)
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
0 Participants
None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
2 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
2 Participants
n=5 Participants • None of the six (6) adult participants advanced beyond the Washout period of the study upon termination.
Chronic Kidney Disease (CKD) Etiology - Pediatric Participants
Diabetic Nephropathy
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Chronic Kidney Disease (CKD) Etiology - Pediatric Participants
Hypertensive Nephropathy
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Chronic Kidney Disease (CKD) Etiology - Pediatric Participants
Glomerulonephritis/ Nephrosis
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Chronic Kidney Disease (CKD) Etiology - Pediatric Participants
Tubulointerstitial
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Chronic Kidney Disease (CKD) Etiology - Pediatric Participants
Congenital Anomalies of the Kidney and Urinary Tract (CAKUT)
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
1 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
1 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Chronic Kidney Disease (CKD) Etiology - Pediatric Participants
Glomerular
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
Chronic Kidney Disease (CKD) Etiology - Pediatric Participants
Other (Unspecified)
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study.
CKD Stage - Adult Participants
CKD stage 1
0 Participants
The number of adult participants diagnosed at each CKD stage, is summarized.
0 Participants
The number of adult participants diagnosed at each CKD stage, is summarized.
0 Participants
n=5 Participants • The number of adult participants diagnosed at each CKD stage, is summarized.
0 Participants
n=5 Participants • The number of adult participants diagnosed at each CKD stage, is summarized.
CKD Stage - Adult Participants
CKD stage 2
0 Participants
The number of adult participants diagnosed at each CKD stage, is summarized.
0 Participants
The number of adult participants diagnosed at each CKD stage, is summarized.
1 Participants
n=5 Participants • The number of adult participants diagnosed at each CKD stage, is summarized.
1 Participants
n=5 Participants • The number of adult participants diagnosed at each CKD stage, is summarized.
CKD Stage - Adult Participants
CKD stage 3a
0 Participants
The number of adult participants diagnosed at each CKD stage, is summarized.
0 Participants
The number of adult participants diagnosed at each CKD stage, is summarized.
1 Participants
n=5 Participants • The number of adult participants diagnosed at each CKD stage, is summarized.
1 Participants
n=5 Participants • The number of adult participants diagnosed at each CKD stage, is summarized.
CKD Stage - Adult Participants
CKD stage 3b
0 Participants
The number of adult participants diagnosed at each CKD stage, is summarized.
0 Participants
The number of adult participants diagnosed at each CKD stage, is summarized.
3 Participants
n=5 Participants • The number of adult participants diagnosed at each CKD stage, is summarized.
3 Participants
n=5 Participants • The number of adult participants diagnosed at each CKD stage, is summarized.
CKD Stage - Adult Participants
CKD stage 4
0 Participants
The number of adult participants diagnosed at each CKD stage, is summarized.
0 Participants
The number of adult participants diagnosed at each CKD stage, is summarized.
0 Participants
n=5 Participants • The number of adult participants diagnosed at each CKD stage, is summarized.
0 Participants
n=5 Participants • The number of adult participants diagnosed at each CKD stage, is summarized.
CKD Stage - Adult Participants
CKD stage 5
0 Participants
The number of adult participants diagnosed at each CKD stage, is summarized.
0 Participants
The number of adult participants diagnosed at each CKD stage, is summarized.
0 Participants
n=5 Participants • The number of adult participants diagnosed at each CKD stage, is summarized.
0 Participants
n=5 Participants • The number of adult participants diagnosed at each CKD stage, is summarized.
CKD Stage - Pediatric Participants
CKD stage 1
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
CKD Stage - Pediatric Participants
CKD stage 2
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
1 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
1 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
CKD Stage - Pediatric Participants
CKD stage 3a
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
CKD Stage - Pediatric Participants
CKD stage 3b
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
CKD Stage - Pediatric Participants
CKD stage 4
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
CKD Stage - Pediatric Participants
CKD stage 5
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.
0 Participants
n=1 Participants • Only one (1) pediatric participant was consented/enrolled into the study. The CKD stage this participant was diagnosed with at consent is listed in the table.

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Baseline HR-pQCT scans were obtained however were not processed and analyzed due to study termination. As such, no baseline volumetric BMD distal radius results data are available. 0 patients were randomized into the Potassium Citrate arm. 1 (pediatric) patient was randomized into the Placebo arm. The study was terminated shortly thereafter and no patients reached the 6-month timepoint and no HR-pQCT scans were obtained at this timepoint.

Change in total volumetric BMD will be analyzed by high resolution peripheral quantitative computed tomography (HR-pQCT). The 6-month absolute and relative (percent) changes in Z-score in distal radius total volumetric BMD will summarized by study arm and analyzed for between group treatment changes.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Baseline HR-pQCT scans were obtained however were not processed and analyzed due to study termination. As such, no baseline volumetric BMD tibia results data are available to report. 0 patients were randomized into the Potassium Citrate arm. 1 (pediatric) patient was randomized into the Placebo arm. The study was terminated shortly thereafter and no patients reached the 6-month timepoint and no HR-pQCT scans were obtained at this timepoint.

Change in total volumetric BMD will be analyzed by high resolution peripheral quantitative computed tomography (HR-pQCT). The 6-month absolute and relative (percent) changes in Z-score in tibia total volumetric BMD will summarized by study arm and analyzed for between group treatment changes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Baseline urine samples were collected from several participants; however, were never analyzed due to concerns for batch effect. As such, no baseline urine NAE data is available. 0 patients were randomized into the Potassium Citrate arm. 1 (pediatric) patient was randomized into the Placebo arm. The study was terminated soon thereafter and no patients reached the 6-month timepoint and no urine samples were obtained at this timepoint.

Change in 24-hour urinary NAE from baseline will be assessed by analyzing samples obtained from 24-hour timed urine collections using laboratory titration methods. Results will be quantified and summarized by study arm using basic descriptive statistics and subsequently analyzed for between group treatment changes. Standard urinary NAE values vary but can range from 250-750 mg/24 hours (1.48 to 4.43 mmol/24 hours).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Blood samples for circulating PTH assay were collected at baseline however were never processed/analyzed due to concerns for batch effect. As such, no baseline PTH concentration data is available. 0 patients were randomized into the Potassium Citrate arm. 1 (pediatric) patient was randomized into the Placebo arm. The study was terminated soon thereafter and 0 patients reached the 6-month collection timepoint and no blood samples were obtained at this timepoint.

Change in circulating PTH concentration from baseline will be assessed by the collection of blood samples via venipuncture and analysis for circulating PTH by an immunoassay. Results will be summarized by study arm using basic descriptive statistics and subsequently statistically analyzed for between group changes. Standard PTH reference ranges can vary but are generally between 10-65 pg/mL in plasma.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Blood samples for circulating biomarkers of bone resorption were collected at baseline; however, were never analyzed due to concerns for batch effect. As such, no baseline circulating biomarkers data is available. 0 patients were randomized into the Potassium Citrate arm. 1 (pediatric) patient was randomized into the Placebo arm. The study was terminated soon thereafter and no patients reached the 6-month timepoint and no blood samples were obtained at this timepoint.

Change in circulating biomarkers of bone resorption from baseline will be assessed following the collection of blood samples via venipuncture and subsequent analysis for circulating C-terminal telopeptides of type I collagen using a cross-linking telopeptide of type I collagen (CTX blood test) assay. C-terminal telopeptides can be used as a biomarker to measure bone resorption and turnover. Elevated levels of C-terminal telopeptide can be indicative of increased bone resorption. While standard reference ranges for C-terminal telopeptide can vary, for premenopausal women ranges are typically 40-465 pg/mL in serum and 19-83 ug/L in plasma.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Blood samples for circulating biomarkers for P1NP were collected at baseline; however, were never analyzed due to concerns for batch effect. As such, no baseline P1NP data is available to report. 0 patients were randomized into the Potassium Citrate arm. 1 (pediatric) patient was randomized into the Placebo arm. The study was terminated soon thereafter and no patients reached the 6-month timepoint and no blood samples were obtained at this timepoint.

Change in circulating biomarker of bone formation from baseline will be assessed following the collection of blood samples via venipuncture and subsequent analysis for procollagen type-1 N-terminal propeptide (P1NP). A P1NP assay measures the amount of amino-terminal propeptide of type I procollagen in the serum and can be used as biomarker to measure the rate of bone formation. While reference ranges can vary by age, standard reference ranges in adult premenopausal women are 19-83 ug/L.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Correlation coefficient will be determined between serum bicarbonate and urine net acid excretion. The correlation coefficient is a number between 0 and 1, with 0 being no correlation and 1 being perfect correlation.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Correlation coefficient will be determined between serum bicarbonate and bone quality. The correlation coefficient is a number between 0 and 1, with 0 being no correlation and 1 being perfect correlation.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Correlation coefficient will be determined between urine net acid excretion and bone quality. The correlation coefficient is a number between 0 and 1, with 0 being no correlation and 1 being perfect correlation.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Changes in bone alkaline phosphatase will be compared between the groups. Bone alkaline phosphatase is measured in IU/L. Higher values are indicative of higher bone turnover.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Changes in TRAP5b compared between the groups. TRAP5b are measured in mIU/mL.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Bone quality as measured by high resolution peripheral quantitative CT will be compared between groups.

Outcome measures

Outcome data not reported

Adverse Events

Potassium Citrate

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Run-In Participants

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Potassium Citrate
Potassium Citrate extended-release tablets 30 mEq twice daily. 1 mEq/kg/day divided into two doses for children to a maximum dose of 30 mEq twice daily. OR (for children who cannot take pills): Potassium citrate and citric acid for oral solution 1 mEq/kg/day divided into two doses to a maximum dose of 30 mEq twice daily Potassium Citrate Extended Release Oral Tablet: Oral potassium citrate extended-release tablet Potassium Citrate and Citric Acid Oral Solution: Oral potassium citrate and citric acid
Placebo
n=1 participants at risk
Placebo capsules identical to the active capsules. Placebo: Placebo capsule identical to active ingredient
Run-In Participants
n=4 participants at risk
Run-in period prior to randomization.
Investigations
Hyperkalemia
—
0/0 • Up to 3 months at the time of study termination.
Zero (0) patients were randomized into the Potassium Citrate arm at the time of study termination.
0.00%
0/1 • Up to 3 months at the time of study termination.
Zero (0) patients were randomized into the Potassium Citrate arm at the time of study termination.
25.0%
1/4 • Number of events 1 • Up to 3 months at the time of study termination.
Zero (0) patients were randomized into the Potassium Citrate arm at the time of study termination.
Gastrointestinal disorders
Vomiting
—
0/0 • Up to 3 months at the time of study termination.
Zero (0) patients were randomized into the Potassium Citrate arm at the time of study termination.
100.0%
1/1 • Number of events 1 • Up to 3 months at the time of study termination.
Zero (0) patients were randomized into the Potassium Citrate arm at the time of study termination.
0.00%
0/4 • Up to 3 months at the time of study termination.
Zero (0) patients were randomized into the Potassium Citrate arm at the time of study termination.

Additional Information

Dr. Kimberly Reidy

Albert Einstein College of Medicine

Phone: 718-655-1120

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place