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NCT00866879 · ClinicalTrials.gov registry record · Phase 4

Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients

A Phase 4 study, sponsored by Northwestern University.

Completed
Registry status
Phase 4
Development phase
275
Enrollment target

NCT00866879 is a Phase 4 study that has completed, run by Northwestern University. The registered enrollment target is 275 participants.

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The verdict

NCT00866879, a Phase 4 study, has completed, sponsored by Northwestern University.

COMPLETED
Registry status
Phase 4
Development phase
275 participants
Enrollment target

Study Summary

This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to sirolimus (Rapamune®) between 6 and 24 months post transplant. The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil(MMF)/Cellcept® and tacrolimus(TAC)/Prograf® (Group 1) or mycophenolate mofetil(MMF)/Cellcept® and sirolimus/Rapamune® (Group 2) impacts the incidence of acute cellular rejection in post kidney transplant patients. This study will examine whether switching from tacrolimus to sirolimus will better preserve long-term kidney function.

Interventions

  • DRUG Sirolimus
  • OTHER Demographic Data, Medical History, and Donor Data
  • PROCEDURE Blood Draws for Control Group
  • PROCEDURE Blood Draws for Experimental Group
  • PROCEDURE Donor Blood Draws

Trial Details

FieldValue
Enrollment Target 275 participants
Start Date 2007-06
Est. Completion 2019-03
Phase Phase 4

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT00866879

The ClinicalTrials.gov registry entry for NCT00866879 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 275 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Sirolimus is the first listed.

NCT00866879 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00866879 about?

NCT00866879 is a clinical study titled "Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients". This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to sirolimus (Rapamune®) between 6 and 24 months post transplant. The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil(MMF)/Cellcept® ...

What is the current status of trial NCT00866879?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 275 participants. The study started on 2007-06. Estimated completion is 2019-03.

What interventions are being tested in trial NCT00866879?

The interventions under investigation include: Sirolimus (DRUG), Demographic Data, Medical History, and Donor Data (OTHER), Blood Draws for Control Group (PROCEDURE), Blood Draws for Experimental Group (PROCEDURE), Donor Blood Draws (PROCEDURE).

Who is sponsoring clinical trial NCT00866879?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.