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NCT01219855 · ClinicalTrials.gov registry record · Phase 2
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
A Phase 2 study, sponsored by OPKO Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
NCT01219855: Completed Phase 2 study, sponsored by OPKO Health.
NCT01219855 is a Phase 2 study that has completed, run by OPKO Health. The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01219855, a Phase 2 study, has completed, sponsored by OPKO Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
Study Summary
This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
Primary Outcome
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.
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT01219855 record still lists
NCT01219855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 5 interventions - of which Cohort 1 CTAP101 Capsules- 60µg is the first listed.
NCT01219855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01219855 about?
NCT01219855 is a clinical study titled "Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)". This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperpara...
What is the current status of trial NCT01219855?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2010-10. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01219855?
The interventions under investigation include: 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 (DRUG).
Who is sponsoring clinical trial NCT01219855?
This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01219855's enrollment target sits among peer trials
78 884th of 2000 higher than 1,110 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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