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NCT00415584 · ClinicalTrials.gov registry record · Phase 1
Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients
A Phase 1 study, sponsored by Montefiore Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00415584: Clinical Trial Phase 1 study, sponsored by Montefiore Medical Center.
NCT00415584 is a Phase 1 study that was terminated before completion, run by Montefiore Medical Center. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00415584, a Phase 1 study, was terminated before completion, sponsored by Montefiore Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Secondary hyperparathyroidism can persist following successful renal transplantation and can cause high blood calcium, kidney dysfunction or failure and excessive bone loss among other problems. If the condition does not resolve, surgery is frequently required to remove the parathyroid glands, with all the inherent risks of surgery. Cinacalcet, a medicine used to treat secondary hyperparathyroidism in patients with kidney disease, may be effective in treating this condition in renal transplant recipients. The investigator team will study the effect of cinacalcet on calcium, bone and renal function in a 6 month treatment protocol.
Primary Outcome
Serum calcium was to have been assessed by drawing venous blood samples for serum analysis. Normal blood calcium levels for adults range from approximately 8.5 to 10.4 mg/dL, but vary depending on laboratory reference ranges. Changes in serum calcium levels from baseline following treatment with Cinacalcet HCl were to have been summarized and evaluated using paired t-tests.
Interventions
- DRUG Cinacalcet HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2007-02-09 |
| Est. Completion | 2009-11 |
| Phase | Phase 1 |
Why NCT00415584 stopped before completion
NCT00415584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Cinacalcet HCl is the first listed.
NCT00415584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00415584 about?
NCT00415584 is a clinical study titled "Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients". Secondary hyperparathyroidism can persist following successful renal transplantation and can cause high blood calcium, kidney dysfunction or failure and excessive bone loss among other problems. If the condition does not resolve, surgery is frequently required to remove the parathyroid glands, with ...
What is the current status of trial NCT00415584?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2007-02-09. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00415584?
The interventions under investigation include: Cinacalcet HCl (DRUG).
Who is sponsoring clinical trial NCT00415584?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00415584's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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