Trial Outcomes & Findings for Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease (NCT NCT04019379)
NCT ID: NCT04019379
Last Updated: 2024-09-19
Results Overview
Determined by kinetic modeling of serum and urine Ca-44 isotope after oral and IV isotope administrations
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
48 hours
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Sequence A
High Phos crossover to Low Phos
High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)
Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
|
Sequence B
Low Phos crossover to High Phos
Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Sequence A
n=1 Participants
High Phos crossover to Low Phos
High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)
Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
|
Sequence B
n=2 Participants
Low Phos crossover to High Phos
Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Continuous
|
71 years
n=99 Participants
|
52 years
n=107 Participants
|
58 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
estimated glomerular filtration rate (eGFR)
|
40 mL/min/1.73m^2
n=99 Participants
|
35 mL/min/1.73m^2
n=107 Participants
|
37 mL/min/1.73m^2
n=206 Participants
|
|
body mass index (BMI)
|
34.7 kg/m^2
n=99 Participants
|
20.5 kg/m^2
n=107 Participants
|
25.2 kg/m^2
n=206 Participants
|
|
Serum phosphorus
|
2.5 mg/dL
n=99 Participants
|
2.7 mg/dL
n=107 Participants
|
2.6 mg/dL
n=206 Participants
|
|
Serum intact fibroblast growth factor-23 (iFGF23)
|
27.6 pg/mL
n=99 Participants
|
78.3 pg/mL
n=107 Participants
|
61.4 pg/mL
n=206 Participants
|
|
Serum 1,25-dihydroxyvitamin D3 (1,25D)
|
46 pg/mL
n=99 Participants
|
26 pg/mL
n=107 Participants
|
32 pg/mL
n=206 Participants
|
|
Serum intact parathyroid hormone (iPTH)
|
85.5 pg/mL
n=99 Participants
|
154.7 pg/mL
n=107 Participants
|
131.7 pg/mL
n=206 Participants
|
PRIMARY outcome
Timeframe: 48 hoursDetermined by kinetic modeling of serum and urine Ca-44 isotope after oral and IV isotope administrations
Outcome measures
| Measure |
High Phosphorus Diet
n=3 Participants
High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)
|
Low Phosphorus Diet
n=3 Participants
Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
|
|---|---|---|
|
Fractional Calcium Absorption
|
0.30 fraction of 1.00
Interval 0.22 to 0.45
|
0.42 fraction of 1.00
Interval 0.22 to 0.8
|
PRIMARY outcome
Timeframe: 48 hoursDetermined by kinetic modeling of serum and urine P-33 isotope after oral and IV isotope administrations
Outcome measures
| Measure |
High Phosphorus Diet
n=3 Participants
High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)
|
Low Phosphorus Diet
n=3 Participants
Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
|
|---|---|---|
|
Fractional Phosphorus Absorption
|
0.73 fraction of 1.00
Interval 0.58 to 0.95
|
0.69 fraction of 1.00
Interval 0.51 to 0.91
|
PRIMARY outcome
Timeframe: 1 weekDetermined by analysis of calcium content in complete 24-hour urine and stool collections, subtracted from the diet calcium content consumed. Values can be negative, zero, or positive.
Outcome measures
| Measure |
High Phosphorus Diet
n=3 Participants
High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)
|
Low Phosphorus Diet
n=3 Participants
Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
|
|---|---|---|
|
Calcium Balance
|
126 mg/d
Interval -36.0 to 343.0
|
199 mg/d
Interval 117.0 to 315.0
|
PRIMARY outcome
Timeframe: 1 weeksDetermined by analysis of phosphorus content in complete 24-hour urine and stool collections, subtracted from the diet phosphorus content consumed. Values can be negative, zero, or positive.
Outcome measures
| Measure |
High Phosphorus Diet
n=3 Participants
High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)
|
Low Phosphorus Diet
n=3 Participants
Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
|
|---|---|---|
|
Phosphorus Balance
|
65 mg/d
Interval -292.0 to 481.0
|
73 mg/d
Interval -144.0 to 416.0
|
SECONDARY outcome
Timeframe: Day 1-8Determined by enzyme-linked immunoassay (ELISA). Values for each subject are an average of 6 serial measures taken during the 1 week balance period (between Days 1-8)
Outcome measures
| Measure |
High Phosphorus Diet
n=3 Participants
High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)
|
Low Phosphorus Diet
n=3 Participants
Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
|
|---|---|---|
|
Serum Intact Fibroblast Growth Factor 23 (iFGF23)
|
67.9 pg/mL
Interval 47.9 to 96.2
|
53.4 pg/mL
Interval 44.1 to 68.6
|
SECONDARY outcome
Timeframe: Day 1-8Determined by enzyme-linked immunoassay (ELISA). Values for each subject are an average of 6 serial measures taken during the 1 week balance period (between Days 1-8)
Outcome measures
| Measure |
High Phosphorus Diet
n=3 Participants
High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)
|
Low Phosphorus Diet
n=3 Participants
Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
|
|---|---|---|
|
Serum Intact Parathyroid Hormone (iPTH)
|
122.7 pg/mL
Interval 101.2 to 136.2
|
104.7 pg/mL
Interval 92.2 to 113.4
|
SECONDARY outcome
Timeframe: Day 1Determined by LC-MS/MS. Values are from Day 1 of the metabolic balance period (following 1 week of acclimation to assigned study diet).
Outcome measures
| Measure |
High Phosphorus Diet
n=3 Participants
High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)
|
Low Phosphorus Diet
n=3 Participants
Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
|
|---|---|---|
|
Serum 1,25-dihydroxyvitamin D (1,25D)
|
29.7 pg/mL
Interval 21.0 to 40.0
|
29.7 pg/mL
Interval 17.0 to 41.0
|
Adverse Events
High Phosphorus Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Phosphorus Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place