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NCT00656266 · ClinicalTrials.gov registry record · Phase 4
Trial of Calcineurin Inhibitor-Sparing Immunosuppression Regimen in Pediatric Liver Transplantation
A Phase 4 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 4
- Development phase
- 13
- Enrollment target
NCT00656266: Clinical Trial Phase 4 study, sponsored by Baylor College of Medicine.
NCT00656266 is a Phase 4 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 13 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00656266, a Phase 4 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 13 participants
- Enrollment target
Study Summary
The objective of this study is to compare the effects of two liver transplant immunosuppression regimens on renal function. Patients receiving the standard combination of prednisone and high-dose tacrolimus, a drug with known nephrotoxicity (Arm A) will be compared to patients receiving prednisone, low-dose tacrolimus and mycophenolate mofetil (MMF) (Arm B). MMF is an immunosuppression agent that has no associated nephrotoxicity. The primary end point of the study will be renal function as measured by glomerular filtration rate (GFR). Thirty pediatric liver transplant recipients will be randomized to these two arms in a 1:1 ratio (i.e. 15 patients in each group). Secondary end points will measure patient and graft outcome and incidence of immunosuppression-related complications, including: neurotoxicity, diabetes mellitus, growth retardation, vomiting, diarrhea, gastrointestinal hemorrhage, thrombocytopenia, anemia, leukopenia, acute or chronic liver graft rejection, posttransplant lymphoproliferative disease (PTLD), viral infections, fungal infections and bacterial infections.
Primary Outcome
change in glomerular filtration rate (GFR) two years after liver transplantation as calculated by the Schwartz formula
Interventions
- DRUG mycophenolate mofetil
- OTHER placebo medication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2004-11 |
| Est. Completion | 2005-11 |
| Phase | Phase 4 |
Why NCT00656266 stopped before completion
NCT00656266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which mycophenolate mofetil is the first listed.
NCT00656266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00656266 about?
NCT00656266 is a clinical study titled "Trial of Calcineurin Inhibitor-Sparing Immunosuppression Regimen in Pediatric Liver Transplantation". The objective of this study is to compare the effects of two liver transplant immunosuppression regimens on renal function. Patients receiving the standard combination of prednisone and high-dose tacrolimus, a drug with known nephrotoxicity (Arm A) will be compared to patients receiving prednisone, ...
What is the current status of trial NCT00656266?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 13 participants. The study started on 2004-11. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00656266?
The interventions under investigation include: mycophenolate mofetil (DRUG), placebo medication (OTHER).
Who is sponsoring clinical trial NCT00656266?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00656266's enrollment target sits among peer trials
13 1910th of 2000 higher than 88 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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