Status:
COMPLETED
Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
Lead Sponsor:
Amgen
Conditions:
Chronic Allograft Nephropathy
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 3 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2013
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00975000
Start Date
December 3 2009
End Date
April 16 2013
Last Update
October 17 2018
Active Locations (51)
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1
Research Site
Phoenix, Arizona, United States, 85012
2
Research Site
Tempe, Arizona, United States, 85284
3
Research Site
San Francisco, California, United States, 94143
4
Research Site
Aurora, Colorado, United States, 80045