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. / Estudio aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y seguridad del uso de Cinacalcet para corregir la hipercalcemia en pacientes trasplantados de riñón con hiperparatiroidismo autónomo

INTERVENTION: Product Name: Cinacalcet Product Code: AMG 073 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Cinacalcet Current Sponsor code: AMG 073 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Cinacalcet Product Code: AMG 073 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Cinacalcet Current Sponsor code: AMG 073 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 60‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Cinacalcet Product Code: AMG 073 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Cinacalcet Current Sponsor code: AMG 073 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 90‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Renal transplant recipients with hypercalcemia and autonomous hyperparathyroidism./ Hipercalcemia en pacientes trasplantados de riñón con hiperparatiroidismo autónomo. ; MedDRA version: 9.1 Level: LLT Classification code 10020587 Term: Hypercalcemia PRIMARY OUTCOME: Main Objective: To demonstrate the efficacy of cinacalcet for correcting hypercalcemia in kidney transplant recipients with autonomous hyperparathyroidism (HPT). Primary end point(s): The primary endpoint is the achievement of a mean corrected total serum calcium value < 10.2 mg/dL (2.55 mmol/L) during the EAP. For each subject, the mean of all corrected total serum calcium values available from weeks 21 to 26 will be calculated. A responder is defined as a subject whose mean corrected total serum calcium value is < 10.2 mg/dL (2.55 mmol/L). For subjects with no data during weeks 21 to 26, the mean of the last 2 available post‐baseline corrected total serum calcium values will be used to calculate the endpoint. If only 1 post‐baseline corrected total serum calcium value is available, this single value will be used. Secondary Objective: To assess the efficacy of cinacalcet for increasing bone mineral density at the femoral neck.; To evaluate the efficacy of cinacalcet for raising serum phosphorus levels.; ; Other; ; To evaluate the impact of cinacalcet on kidney transplant function.; To evaluate the efficacy of cinacalcet for reducing corrected total serum calcium levels.; To evaluate the efficacy of cinacalcet for reducing plasma intact parathyroid hormone (iPTH) levels.; To assess the impact of cinacalcet on urinary calcium and phosphorus excretion.; To assess the safety and tolerability of cinacalcet (including evaluations of adverse events, acute rejection, kidney transplant failure, incidence of parathyroidectomy and hypocalcemia). INCLUSION CRITERIA: Received a kidney transplant > or = 3 months and < or = 12 months before randomization; may be the first kidney transplant or a repeat kidney transplant. Subjects with a functional, stable kidney transplant, defined as MDRD estimated glomerular filtration rate (eGFR) > or = 45 mL/min/1.73 m2 and < or = 10% decrease in eGFR for at least 6 weeks before screening. Estimated GFR (mL/min) will be calculated by the IVRS using the MDRD equation: eGFRMDRD = 175 x [SCr]‐1.154 x [age]‐0.203 x [0.742 if subject is female] x [1.212 if subject is African American] where SCr is the serum creatinine. Men or women > or = 18 years at the start of screening (ie, time of informed consent). Corrected total serum calcium > 10.5 mg/dL (2.63 mmol/L), defined as the mean of 2 values in screening period. iPTH > 100 pg/mL (10.6 pmol/L), defined as the mean of 2 values in the screening period. Are the trial subjects under 18? no Numbe