Trials / Completed
CompletedNCT00975000
Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cinacalcet | Possible sequential doses are 30, 60, 90, 120, and 180 mg. |
| DRUG | Placebo | Administered orally following the same dosing regimen as the experimental arm. |
Timeline
- Start date
- 2009-12-03
- Primary completion
- 2012-09-13
- Completion
- 2013-04-16
- First posted
- 2009-09-11
- Last updated
- 2018-10-17
- Results posted
- 2016-01-29
Locations
51 sites across 11 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Poland, Spain, Switzerland
Source: ClinicalTrials.gov record NCT00975000. Inclusion in this directory is not an endorsement.