drugset / Trial / NCT00975000

Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients

NCT00975000

Phase 3 Completed 114 enrolled Amgen
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2009-12-03
Primary completion
2012-09-13
Completion
2013-04-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Cinacalcet Other / unclassified 30 mg Oral
Subject Cinacalcet Other / unclassified 60 mg Oral
Subject Cinacalcet Other / unclassified 90 mg Oral
Subject Cinacalcet Other / unclassified 120 mg Oral
Subject Cinacalcet Other / unclassified 180 mg Oral