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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: Completed Phase 4 study of Kidney Transplant Recipient and Heart Transplant Recipient, sponsored by University of Michigan.

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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DRUG Valganciclovir
  • DRUG Mycophenolate mofetil

Study Locations (1)

Michigan

  • University of Michigan Hospital - Ann Arbor

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2005-04
Est. Completion 2007-08
Phase Phase 4
University of Michigan

1,327 total trials

What the finished NCT00189150 record still lists

NCT00189150 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 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 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 a single indexed study location in 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.

How this trial's enrollment target compares

Where NCT00189150's enrollment target sits among peer trials

16 1870th of 2000 higher than 121 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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Source: ClinicalTrials.gov NCT00189150, the US trial registry maintained by the National Library of Medicine. NCT00189150 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.