| Trial ID: | L1363 |
| Source ID: | NCT01651000
|
| Associated Drug: |
Ctap101 30 Μg Capsules
|
| Title: |
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01651000/results
|
| Conditions: |
Chronic Kidney Disease|Hyperparathyroidism, Secondary|Vitamin D Deficiency
|
| Interventions: |
DRUG: CTAP101 30 μg capsules|OTHER: Sugar pill to CTAP101 30 μg capsules
|
| Outcome Measures: |
Primary: Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values, Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders., Approximately 6 months | Secondary: Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values, Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders., Approximately 6 months|Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D, Subjects in the Intent to Treat Population with normal serum total 25-hydroxyvitamin D (\>/= 30 ng/dL), Approximately 6 months|Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D, Subjects in the Per Protocol Population with normal serum total 25-hydroxyvitamin D (\>/= 30 ng/mL), Approximately 6 months
|
| Sponsor/Collaborators: |
Sponsor: OPKO IP Holdings II, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
213
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-09
|
| Completion Date: |
2014-07
|
| Results First Posted: |
2016-08-17
|
| Last Update Posted: |
2025-01-13
|
| Locations: |
OPKO Renal, Bannockburn, Illinois, 60015, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01651000
|
