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
Keywords: Intervention Cinacalcet Sensipar Mimpara hyperparathyroidism calcium osteodystrophy hypercalcemia renal transplant acute rejection kidney transplant failure hypophosphatemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 114
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 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. arm 2: Participants received placebo orally once daily for 52 weeks.

Interventions: intervention 1: Cinacalcet intervention 2: Placebo
Intervention descriptions: intervention 1: Possible sequential doses are 30, 60, 90, 120, and 180 mg. intervention 2: Administered orally following the same dosing regimen as the experimental arm.

Protocol document: