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NCT00616902 · ClinicalTrials.gov registry record · Phase 3
The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5
A Phase 3 study, sponsored by Abbott.
- Terminated
- Registry status
- Phase 3
- Development phase
- 12
- Enrollment target
NCT00616902: Clinical Trial Phase 3 study, sponsored by Abbott.
NCT00616902 is a Phase 3 study that was terminated before completion, run by Abbott. The registered enrollment target is 12 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00616902, a Phase 3 study, was terminated before completion, sponsored by Abbott.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 12 participants
- Enrollment target
Study Summary
To evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH).
Primary Outcome
Change from Baseline in left ventricular mass index (LVMI) over 48 weeks measured by cardiac MRI. The effects of paricalcitol injection on progression or regression of left ventricular hypertrophy (LVH) in participants with Stage 5 chronic kidney disease (CKD) on hemodialysis (HD) compared to placebo. Left Ventricular Mass is normalized to the participant's height by the following equation to obtain LVMI: LVM (g) divided by height (m)2.7. The primary comparison was between the 4 mcg paricalcito
Interventions
- DRUG paricalcitol injection 4 mcg/mL
- DRUG Placebo Injection 4 mcg/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-01 |
| Est. Completion | 2009-05 |
| Phase | Phase 3 |
Why NCT00616902 stopped before completion
NCT00616902 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which paricalcitol injection 4 mcg/mL is the first listed.
NCT00616902 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00616902 about?
NCT00616902 is a clinical study titled "The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5". To evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH).
What is the current status of trial NCT00616902?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2009-01. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00616902?
The interventions under investigation include: paricalcitol injection 4 mcg/mL (DRUG), Placebo Injection 4 mcg/mL (DRUG).
Who is sponsoring clinical trial NCT00616902?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00616902's enrollment target sits among peer trials
12 1984th of 2000 higher than 12 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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