| Trial ID: | L1288 |
| Source ID: | NCT01219855
|
| Associated Drug: |
Cohort 1 Ctap101 Capsules- 60µg
|
| Title: |
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01219855/results
|
| Conditions: |
Chronic Kidney Disease|Secondary Hyperparathyroidism|Vitamin D Insufficiency
|
| Interventions: |
DRUG: Cohort 1 CTAP101 Capsules- 60µg|DRUG: Cohort 1 CTAP101 Capsules - 90µg|DRUG: Cohort 1 Matching Sugar Capsule|DRUG: Cohort 2 CTAP101 Capsules - 30µg|DRUG: Cohort 2 Matching Sugar Capsule
|
| Outcome Measures: |
Primary: Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP)., The proportion of subjects in the per protocol population with serum 25-hydroxyvitamin D ≥30 ng/mL at End-of-Treatment (EOT; Week 6) in Cohorts 1 and 2 (60/90 and 30 μg groups, respectively) were compared to their corresponding placebo groups., 6 weeks|Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population), Mean percent change from baseline in plasma intact parathyroid hormone (iPTH) from baseline to End of Treatment (EOT) in the Per Protocol population. Subjects in Cohorts 1 and 2 (dose regimens 60/90 and 30 mcg, respectively) were compared to their respective placebo groups., 6 weeks | Secondary: Change From Baseline in Serum 25-hydroxyvitamin D at Week 6, Mean absolute change from baseline in serum total 25-hydroxyvitamin D to end of treatment (EOT), Baseline to End of Treatment (6 weeks)|Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population, Mean percent change from baseline in serum 25-hydroxyvitamin D at End of Treatment (EOT, week 6) in the per protocol population. Subjects in Cohorts 1 and 2 (dose regimens of 60/90 and 30 mcg, respectively) were compared versus their corresponding placebo groups., Baseline to End of Treatment (6 weeks)|Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6, Proportion of subjects with at least 30% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT), Baseline to End of Treatment (6 weeks)|Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6, Proportion of subjects with at least 20% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT), Baseline to End of Treatment (6 weeks)
|
| Sponsor/Collaborators: |
Sponsor: OPKO Health, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
78
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-10
|
| Completion Date: |
2011-11
|
| Results First Posted: |
2016-08-25
|
| Last Update Posted: |
2016-08-25
|
| Locations: |
OPKO Health, Inc, Bannockburn, Illinois, 60015, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01219855
|
