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NCT00596947 · ClinicalTrials.gov registry record · Phase 4

Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant

A Phase 4 study, sponsored by University of Pennsylvania.

Terminated
Registry status
Phase 4
Development phase
18
Enrollment target

NCT00596947: Clinical Trial Phase 4 study, sponsored by University of Pennsylvania.

NCT00596947 is a Phase 4 study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 18 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00596947, a Phase 4 study, was terminated before completion, sponsored by University of Pennsylvania.

TERMINATED
Registry status
Phase 4
Development phase
18 participants
Enrollment target

Study Summary

The purpose of the study was to determine if rapid discontinuation of corticosteroids (also known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus) and CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin) will give similar safety and efficacy results compared to continuation of corticosteroids (also known as prednisone maintenance) and standard maintenance immunosuppression with Prograf (tacrolimus), CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin).

Primary Outcome

Acute rejection episodes would have been measured by the number of participants who underwent a kidney transplant biopsy, and had the results of the biopsy reported as acute rejection by the transplant pathologist. Biopsies were only performed if clinically indicated. The cumulative number of participants with recorded rejection episodes by 6 and 12 months post-transplant would have been reported.

Interventions

  • DRUG Prednisone
  • DRUG prednisone
  • DRUG Tacrolimus
  • DRUG Mycophenolate mofetil
  • DRUG rabbit antithymocyte globulin

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2005-10
Est. Completion 2009-03
Phase Phase 4
University of Pennsylvania

1,423 total trials

Why NCT00596947 stopped before completion

NCT00596947 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 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 0 conditions, and to 5 interventions - of which Prednisone is the first listed.

NCT00596947 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00596947 about?

NCT00596947 is a clinical study titled "Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant". The purpose of the study was to determine if rapid discontinuation of corticosteroids (also known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus) and CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin) will give similar saf...

What is the current status of trial NCT00596947?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2005-10. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00596947?

The interventions under investigation include: Prednisone (DRUG), prednisone (DRUG), Tacrolimus (DRUG), Mycophenolate mofetil (DRUG), rabbit antithymocyte globulin (DRUG).

Who is sponsoring clinical trial NCT00596947?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00596947's enrollment target sits among peer trials

18 1842nd of 2000 higher than 147 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 NCT00596947, the US trial registry maintained by the National Library of Medicine. NCT00596947 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.