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Clinical Trial Details

Trial ID: L1590
Source ID: NCT00431496
Associated Drug: Cinacalcet
Title: A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00431496/results
Conditions: Anemia|Secondary Hyperparathyroidism
Interventions: DRUG: Cinacalcet
Outcome Measures: Primary: Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2, The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) recommends that treatment interventions to control parathyroid hormone should not result in significant elevation of calcium - phosphorus product (Ca x P; a derived value calculated from serum calcium and phosphorus levels). The primary objective of the study was to assess the simultaneous achievement of NKF K/DOQI targets of intact parathyroid hormone (iPTH) greater than or equal to 15.9 pmol/L and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) and a Ca x P value \< 4.44 mmol\^2/L\^2 (55 mg\^2/dL\^2) during the effectiveness assessment phase., Weeks 17 to 23 | Secondary: Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL, Number of participants who achieved a mean intact Parathyroid Hormone (iPTH) value greater than or equal to 15.9 and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) during the effectiveness assessment phase., Weeks 17 to 23|Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2), The number of participants who achieved a mean serum calcium x phosphorus (Ca x P) value \< 4.44 mmol\^2/L\^2 (55 mg\^2/dL\^2) during the effectiveness assessment phase. The calcium - phosphorus product is a derived value calculated from serum calcium and phosphorus levels., Weeks 17 to 23|Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L, The number of participants who achieved a mean corrected serum calcium (Ca) value ≥ 2.1 and ≤ 2.37 mmol/L (8.4 to 9.5 mg/dL) during the effectiveness assessment phase., Weeks 17 to 23|Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L, The number of participants who achieved a mean serum phosphorus value ≥ 1.13 and ≤ 1.78 mmol/L (3.5 to 5.5 mg/dL) during the effectiveness assessment phase., Weeks 17 to 23|Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL, The number of participants who achieved a mean C-reactive protein (CRP) level of \< 0.6 mg/dL during the effectiveness assessment phase., Weeks 17 to 23
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 71
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2006-09
Completion Date: 2009-10
Results First Posted: 2011-07-13
Last Update Posted: 2013-04-24
Locations:
URL: https://clinicaltrials.gov/show/NCT00431496