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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
114
Possible sequential doses are 30, 60, 90, 120, and 180 mg.
Administered orally following the same dosing regimen as the experimental arm.
Research Site
Phoenix, Arizona, United States
Research Site
Tempe, Arizona, United States
Research Site
San Francisco, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Gainesville, Florida, United States
Research Site
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
Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA).
Time frame: Baseline and Week 52
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
eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
Time frame: Baseline and Week 52
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
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Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Evanston, Illinois, United States
Research Site
Springfield, Massachusetts, United States
Research Site
Detroit, Michigan, United States
...and 41 more locations