Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 13 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00656266
The ClinicalTrials.gov registry entry for NCT00656266 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which mycophenolate mofetil is the first listed.
NCT00656266 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.