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NCT00087581 · ClinicalTrials.gov registry record · Phase 4

Study of Therapeutic Monitoring of Mycophenolate Mofetil (MMF/CellCept) After Kidney Transplantation

A Phase 4 study of Kidney Transplantation, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 4
Development phase
720
Enrollment target
20
Study locations

NCT00087581: Completed Phase 4 study of Kidney Transplantation, sponsored by Hoffmann-La Roche.

NCT00087581 is a Phase 4 study of Kidney Transplantation that has completed, run by Hoffmann-La Roche. The registered enrollment target is 720 participants, above the 246-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (193% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00087581, a Phase 4 study of Kidney Transplantation, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 4
Development phase
720 participants
Enrollment target
20
Study locations

Study Summary

This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or tacrolimus, in participants who have undergone kidney transplantation. Participants will be randomized to one of three dosing regimens to receive concentration-controlled MMF with reduced CNI, concentration-controlled MMF with standard CNI, or fixed-dose MMF with standard CNI. Participants will be followed for 20-24 months after randomization.

Conditions Studied

Kidney Transplantation

Interventions

  • DRUG Tacrolimus
  • DRUG Cyclosporine
  • DRUG Mycophenolate mofetil

Study Locations (20)

Florida

  • - Gainesville
  • - Jacksonville
  • - Miami
  • - Orlando
  • - Tampa

California

  • - Bakersfield
  • - Los Angeles
  • - Los Angeles
  • - San Francisco

Louisiana

  • - New Orleans
  • - Shreveport

Alabama

  • - Birmingham

Arkansas

  • - Little Rock

Colorado

  • - Denver

Georgia

  • - Augusta

Illinois

  • - Chicago

Trial Details

FieldValue
Enrollment Target 720 participants
Start Date 2004-06
Est. Completion 2007-09
Phase Phase 4
Hoffmann-La Roche

909 total trials

What the finished NCT00087581 record still lists

NCT00087581 is an interventional study that assigns participants to a tested intervention. The registered 720 participants enrollment target is mid-sized for trials with a published cap, above the 246-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (193% higher).

The record links to 1 condition, with Kidney Transplantation appearing as the primary indexed condition, and to 3 interventions - of which Tacrolimus is the first listed.

NCT00087581 names 20 study sites across 12 states, led by Florida, California, Louisiana.

Frequently Asked Questions

What is clinical trial NCT00087581 about?

NCT00087581 is a clinical study titled "Study of Therapeutic Monitoring of Mycophenolate Mofetil (MMF/CellCept) After Kidney Transplantation". This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or tacrolimus, in participants who have undergone kidney transplantation. Participants will be randomized to one of t...

What is the current status of trial NCT00087581?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 720 participants. The study started on 2004-06. Estimated completion is 2007-09.

What conditions does trial NCT00087581 study?

This clinical trial studies the following conditions: Kidney Transplantation.

What interventions are being tested in trial NCT00087581?

The interventions under investigation include: Tacrolimus (DRUG), Cyclosporine (DRUG), Mycophenolate mofetil (DRUG).

Who is sponsoring clinical trial NCT00087581?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00087581 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Kidney Transplantation

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00087581's enrollment target sits among peer trials

720 3rd of 33 higher than 31 of 33 other Kidney Transplantation trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Kidney Transplantation 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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Related registry views

Source: ClinicalTrials.gov NCT00087581, the US trial registry maintained by the National Library of Medicine. NCT00087581 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.