Renal transplant recipients with hypercalcemia and autonomous hyperparathyroidism MedDRA version: 9.1 Level: LLT Classification code 10020587 Term: Hypercalcemia
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Received a kidney transplant = 9 weeks at time of Screening and = 12 months before first dose (ie, subjects may receive first dose of investigational product no sooner than 12 weeks post-transplant and no later than 12 months post-transplant); 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) = 30 mL/min/1.73 m2 (CKD Stage 3 or better) at Screening. Estimated GFR (mL/min/1.73 m2) will be calculated by the Interactive Voice Response System (IVRS) using the MDRD equation SI Units: eGFRMDRD = 175 x [SCr/88.4]-1.154 x [age]-0.203 x [0.742 if subject is female] x [1.212 if subject is African American] Conventional Units: 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 = 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 during the screening period. iPTH > 100 pg/mL (10.6 pmol/L), during the Screening period (obtained at Screen 1 or Screen 2). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be ineligible for the study if they fulfill any of the following criteria: Received cinacalcet therapy post-transplant (Note: This does not exclude pre-transplant use of cinacalcet). Anticipated parathyroidectomy within 6 to12 months after randomization. Ongoing therapy with bisphosphonates or use within 6 months prior to screening. Ongoing use of 1,25-dihydroxyvitamin D3 (including other active vitamin D metabolites or analogues) or use within 30 days prior to screening. Ongoing use of calcium supplements or use within 30 days prior to screening. Ongoing use of phosphate binders (calcium or non-calcium containing) or use within 30 days prior to screening. Ongoing use of a thiazide diuretic. Current enrollment in or fewer than 30 days has passed since subject has completed another investigational device or drug study(s); or subject is receiving other investigational agent(s) [ie, less than 30 days prior to randomization]. Refuse to use highly effective contraceptive measures (as determined by the investigator) throughout the study. Evidently pregnant (eg, positive HCG test) or is breast feeding. Known sensitivity to any of the products to be administered during dosing. Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets. Will not be available for follow-up assessment. Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures. Subjects with a history of seizures who had a seizure within the 3 months prior to randomization, which required adjustments to the seizure medication. Acute Kidney Injury (AKI) within 6 weeks prior to screening, defined by creatinine increase greater than or equal to 35.36 µmol/L Renal biopsy within 6 weeks prior to Screening, unless it is an institutional protocol-driven biopsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of cinacalcet for correcting hypercalcemia in kidney transplant recipients with autonomous hyperparathyroidism (HPT).;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);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. | — |
Countries
Austria, Belgium, France, Germany, Italy, Spain
Outcome results
None listed