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NCT00189150 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetics of Mmf and Valganciclovir
A Phase 4 study of Kidney Transplant Recipient and Heart Transplant Recipient, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT00189150 is a Phase 4 study of Kidney Transplant Recipient and Heart Transplant Recipient that has completed, run by University of Michigan. The registered enrollment target is 16 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00189150, a Phase 4 study of Kidney Transplant Recipient and Heart Transplant Recipient, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to determine whether a clinically significant PK drug interaction ( a 30% difference in the AUC of MPA) exists between mycophenolate mofetil (under steady state conditions) and VGCV in renal and cardiac transplant recipients. This study will provide clinically relevant information to the transplant community. It will more clearly delineate whether a clinically significant PK drug interaction exists between mycophenolate mofetil (under steady-state conditions)and VGCV. Given the established dose/efficacy relationship of both MMF and VGCV, this study will provide improved dosing guidelines and potentially avoid adverse outcomes due to empiric dosage adjustments.
Conditions Studied
Interventions
- DRUG Valganciclovir
- DRUG Mycophenolate mofetil
Study Locations (1)
Michigan
- University of Michigan Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2005-04 |
| Est. Completion | 2007-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00189150
The ClinicalTrials.gov registry entry for NCT00189150 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Kidney Transplant Recipient appearing as the primary indexed condition, and to 2 interventions - of which Valganciclovir is the first listed.
NCT00189150 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT00189150 about?
NCT00189150 is a clinical study titled "Pharmacokinetics of Mmf and Valganciclovir". The primary objective of this study is to determine whether a clinically significant PK drug interaction ( a 30% difference in the AUC of MPA) exists between mycophenolate mofetil (under steady state conditions) and VGCV in renal and cardiac transplant recipients. This study will provide clinically...
What is the current status of trial NCT00189150?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2005-04. Estimated completion is 2007-08.
What conditions does trial NCT00189150 study?
This clinical trial studies the following conditions: Kidney Transplant Recipient, Heart Transplant Recipient.
What interventions are being tested in trial NCT00189150?
The interventions under investigation include: Valganciclovir (DRUG), Mycophenolate mofetil (DRUG).
Who is sponsoring clinical trial NCT00189150?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00189150 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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