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| Sponsor: | Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00975000 |
Purpose
Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can cause bone pain, fractures, and poor formation of red blood cells. Other problems from HPT may include increases in blood levels of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). The high calcium levels may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), heart and lung problems or kidney transplant dysfunction (worsening of kidney transplant function). The purpose of this study is to evaluate the effects of cinacalcet (Sensipar/Mimpara) on high calcium levels in the blood in patients with HPT after a kidney transplant.
| Condition | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Cinacalcet |
Drug: Cinacalcet
Possible sequential doses of the investigational product for titration are 30, 60, 90, 120, and 180 mg. Subjects will be considered for dose adjustments of the investigational product and will be dispensed a new supply of investigational product at day 1, weeks 4, 8, 12, 16, 20, 22, 26, 34 and 42. Subjects will be eligible for a dose increase once every 4 weeks during the dose-titration phase and at study visits during the maintenance phase. Dose escalation is permitted during the EAP. Dose escalation will be based on corrected total serum calcium values, iPTH values, and subject safety information. Dose decreases will be permitted at any time during the study. |
| Placebo Comparator: Placebo |
Drug: Placebo
Possible sequential doses of the investigational product for titration are 30, 60, 90, 120, and 180 mg. Subjects will be considered for dose adjustments of the investigational product and will be dispensed a new supply of investigational product at day 1, weeks 4, 8, 12, 16, 20, 22, 26, 34 and 42. Subjects will be eligible for a dose increase once every 4 weeks during the dose-titration phase and at study visits during the maintenance phase. Dose escalation is permitted during the EAP. Dose escalation will be based on corrected total serum calcium values, iPTH values, and subject safety information. Dose decreases will be permitted at any time during the study. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Amgen Call Center | 866-572-6436 |
Show 51 Study Locations| Study Director: | MD | Amgen |
More Information
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00975000 History of Changes |
| Other Study ID Numbers: | 20062007 |
| Study First Received: | September 10, 2009 |
| Last Updated: | January 18, 2012 |
| Health Authority: | Canada: Health Canada United States: Food and Drug Administration United States: Western Institutional Review Board |
|
Intervention Cinacalcet Sensipar Mimpara hyperparathyroidism calcium osteodystrophy |
hypercalcemia renal transplant acute rejection kidney transplant failure hypophosphatemia |
|
Hypercalcemia Hyperparathyroidism Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Renal Insufficiency Hypophosphatemia |
Calcium Metabolism Disorders Metabolic Diseases Water-Electrolyte Imbalance Parathyroid Diseases Endocrine System Diseases Urologic Diseases Phosphorus Metabolism Disorders |