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Clinical Trial Details

Trial ID: L1199
Source ID: NCT00975000
Associated Drug: Cinacalcet
Title: Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00975000/results
Conditions: Chronic Allograft Nephropathy|Chronic Kidney Disease|Chronic Renal Failure|Disordered Mineral Metabolism|End Stage Renal Disease|Hyperparathyroidism|Hypophosphatemia|Kidney Disease|Kidney Transplantation|Post Renal Transplantation
Interventions: DRUG: Cinacalcet|DRUG: Placebo
Outcome Measures: Primary: 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), Weeks 21 to 26 (EAP) | Secondary: 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)., Baseline and Week 52|Change From Baseline to the EAP in Mean Serum Phosphorus, 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., Baseline and Week 52|Change From Baseline to the EAP in Corrected Total Calcium, Baseline and the EAP (mean of Weeks 22, 24, and 26)|Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH), Baseline and the EAP (mean of Weeks 22, 24, and 26)|Change From Baseline to the EAP in Urine Phosphorus, Baseline and the EAP (mean of Weeks 22, 24, and 26)|Percentage of Participants With a Parathyroidectomy, 56 weeks|Time to Parathyroidectomy, 56 weeks
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 114
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2009-12-03
Completion Date: 2013-04-16
Results First Posted: 2016-01-29
Last Update Posted: 2018-10-17
Locations: Research Site, Phoenix, Arizona, 85012, United States|Research Site, Tempe, Arizona, 85284, United States|Research Site, San Francisco, California, 94143, United States|Research Site, Aurora, Colorado, 80045, United States|Research Site, Gainesville, Florida, 32610, United States|Research Site, Atlanta, Georgia, 30322, United States|Research Site, Chicago, Illinois, 60637, United States|Research Site, Evanston, Illinois, 60201, United States|Research Site, Springfield, Massachusetts, 01107, United States|Research Site, Detroit, Michigan, 48202, United States|Research Site, New York, New York, 10032, United States|Research Site, Bethlehem, Pennsylvania, 18017, United States|Research Site, Nashville, Tennessee, 37232, United States|Research Site, Dallas, Texas, 75390, United States|Research Site, Houston, Texas, 77030, United States|Research Site, Camperdown, New South Wales, 2050, Australia|Research Site, Westmead, New South Wales, 2145, Australia|Research Site, Woodville South, South Australia, 5011, Australia|Research Site, Parkville, Victoria, 3050, Australia|Research Site, Wien, 1090, Austria|Research Site, Brussels, 1200, Belgium|Research Site, Gent, 9000, Belgium|Research Site, Leuven, 3000, Belgium|Research Site, Calgary, Alberta, T2N 2T9, Canada|Research Site, Vancouver, British Columbia, V6Z 1Y6, Canada|Research Site, London, Ontario, N6A 5A5, Canada|Research Site, Ottawa, Ontario, K1H 7W9, Canada|Research Site, Toronto, Ontario, M5C 2T2, Canada|Research Site, Bordeaux Cedex, 33076, France|Research Site, Montpellier cedex 05, 34295, France|Research Site, Nantes Cedex 1, 44093, France|Research Site, Paris Cedex 15, 75743, France|Research Site, Toulouse Cedex 09, 31403, France|Research Site, Berlin, 13353, Germany|Research Site, Kiel, 24105, Germany|Research Site, Genova, 16132, Italy|Research Site, Milano, 20122, Italy|Research Site, Padova, 35128, Italy|Research Site, Gdansk, 80-952, Poland|Research Site, Katowice, 40-027, Poland|Research Site, Lodz, 90-153, Poland|Research Site, Poznan, 60-539, Poland|Research Site, Szczecin, 70-111, Poland|Research Site, Málaga, AndalucÃ-a, 29010, Spain|Research Site, Barcelona, Cataluña, 08025, Spain|Research Site, Barcelona, Cataluña, 08036, Spain|Research Site, L'Hospitalet de Llobregat, Cataluña, 08907, Spain|Research Site, Madrid, 28041, Spain|Research Site, Bern, 3010, Switzerland|Research Site, Geneva 14, 1211, Switzerland|Research Site, Zurich, 8091, Switzerland
URL: https://clinicaltrials.gov/show/NCT00975000

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D302 Cinacalcet small molecule DB01012 Details