Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT00975000
Eligibility Criteria:
Inclusion Criteria:
* Received a kidney transplant ≥ 9 weeks at time of Screening and ≤ 24 months before first dose
* 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 (chromic kidney disease stage 3 or better) at Screening.
* 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 in Screening period.
* iPTH \> 100 pg/mL (10.6 pmol/L), during the Screening period (obtained at either Screen 1 or Screen 2).
Exclusion Criteria:
* Received cinacalcet therapy post-transplant for more than 14 days cumulatively post-transplant. If cinacalcet therapy was received for a total of 14 days or less post-transplant, there must be a 4-week washout before subject is eligible for screening (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.
* 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) or renal biopsy within 6 weeks prior to Screening, unless it is an institutional protocol-driven biopsy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00975000
Study Brief:
Protocol Section:
NCT00975000