Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT00975000|
Recruitment Status : Completed
First Posted : September 11, 2009
Results First Posted : January 29, 2016
Last Update Posted : October 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Allograft Nephropathy Chronic Kidney Disease Chronic Renal Failure Disordered Mineral Metabolism End Stage Renal Disease Hyperparathyroidism Hypophosphatemia Kidney Disease Kidney Transplantation Post Renal Transplantation||Drug: Cinacalcet Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Using Cinacalcet to Correct Hypercalcemia in Renal Transplant Recipients With Autonomous Hyperparathyroidism|
|Actual Study Start Date :||December 3, 2009|
|Actual Primary Completion Date :||September 13, 2012|
|Actual Study Completion Date :||April 16, 2013|
Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on intact parthyroid hormone (iPTH) values, corrected total serum calcium values, and safety assessments.
Possible sequential doses are 30, 60, 90, 120, and 180 mg.
Placebo Comparator: Placebo
Participants received placebo orally once daily for 52 weeks.
Administered orally following the same dosing regimen as the experimental arm.
- Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP) [ Time Frame: Weeks 21 to 26 (EAP) ]
- Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck [ Time Frame: Baseline and Week 52 ]Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA).
- Change From Baseline to the EAP in Mean Serum Phosphorus [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]
- Change From Baseline to Week 52 in eGFR [ Time Frame: Baseline and Week 52 ]eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
- Change From Baseline to the EAP in Corrected Total Calcium [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]
- Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH) [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]
- Change From Baseline to the EAP in Urine Phosphorus [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]
- Percentage of Participants With a Parathyroidectomy [ Time Frame: 56 weeks ]
- Time to Parathyroidectomy [ Time Frame: 56 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975000