Trial Outcomes & Findings for Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients (NCT NCT00415584)
NCT ID: NCT00415584
Last Updated: 2025-04-29
Results Overview
Serum calcium was to have been assessed by drawing venous blood samples for serum analysis. Normal blood calcium levels for adults range from approximately 8.5 to 10.4 mg/dL, but vary depending on laboratory reference ranges. Changes in serum calcium levels from baseline following treatment with Cinacalcet HCl were to have been summarized and evaluated using paired t-tests.
TERMINATED
PHASE1/PHASE2
4 participants
Baseline to 6 Months
2025-04-29
Participant Flow
Participant milestones
| Measure |
Cinacalcet Hydrochloride (HCl)
Cinacalcet Hydrochloride (HCl)
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cinacalcet Hydrochloride (HCl)
Cinacalcet Hydrochloride (HCl)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients
Baseline characteristics by cohort
| Measure |
Cinacalcet HCl
n=4 Participants
Cinacalcet HCl
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 MonthsPopulation: Venous blood samples were not collected and processed and, as such, serum calcium data was not available for this study.
Serum calcium was to have been assessed by drawing venous blood samples for serum analysis. Normal blood calcium levels for adults range from approximately 8.5 to 10.4 mg/dL, but vary depending on laboratory reference ranges. Changes in serum calcium levels from baseline following treatment with Cinacalcet HCl were to have been summarized and evaluated using paired t-tests.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6 MonthsPopulation: GFR data was not collected for this study and changes in renal function were not able to be assessed.
Change in renal function from baseline was to have been assessed at 6 months based on a measurement of Glomerular Filtration Rate (GFR). Normal GFR ranges vary based on age, sex, and body size but are typically \> 90 mL/min/1.73 m\^2 for healthy individuals. Changes in renal glomerular filtration rate from baseline following treatment with Cinacalcet HCl were to have been summarized and evaluated using paired t-tests.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6 MonthsPopulation: Bone mineral density scans taken yielded inconsistent/unreliable results and, as such, powered statistical testing was not conducted. Left forearm scans were only obtained for 3 of the 4 patients.
Changes in bone mineral density was assessed using central dual energy x-ray absorptiometry (DXA or DEXA). DXA uses radiation to measure how much calcium and other minerals are in a specific area of the bone. For this study, changes in bone mineral density of the left hip, lumbar spine, and left forearm (vs baseline) have been summarized and reported as a percentage change from baseline. Statistical t-tests were not conducted due to limited sample size.
Outcome measures
| Measure |
Cinacalcet HCl
n=4 Participants
Cinacalcet HCl
|
|---|---|
|
Changes in Bone Mineral Density
Left Hip
|
-6.9 percentage change from basline
Interval -9.5 to -2.7
|
|
Changes in Bone Mineral Density
Spine - Lumbar
|
-12.9 percentage change from basline
Interval -17.3 to -2.4
|
|
Changes in Bone Mineral Density
Left Forearm
|
-1.2 percentage change from basline
Interval -7.1 to -0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 6 MonthsPopulation: Crest bone biopsy samples were collected from the four patients; however, results could not be generalized.
Changes in bone turnover rate from baseline were to have been assessed by bone histology and histomorphometry. This was to have been conducted by an examination of bone biopsies, collected after double labeling with tetracycline compounds \~21 days prior to the procedure, to assess for bone turnover and structure. This was to have been a largely observational endpoint as no studies published at the time have described the effect of Cinacalcet HCl on bone histology.
Outcome measures
Outcome data not reported
Adverse Events
Cinacalcet HCl
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