Study to Evaluate Safety and Efficacy of Early Calcineurin Inhibitor Withdrawal in Primary Renal Allografts

July 8, 2021 updated by: E. Steve Woodle, University of Cincinnati

Open Label Randomized Single Study to Evaluate the Safety & Efficacy of Early CNI Withdrawal in Recipients of Primary Renal Allografts Maintained Long-Term on Mycophenolate Mofetil; MMF (CellCept) and Sirolimus (Rapamune)

Evaluate the safety and efficacy of early corticosteroid withdrawal and simultaneous calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained long-term on MMF and sirolimus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cincinnati, Ohio, United States, 45267
        • The Christ Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients between 18 and 75 years of age.
  • Patients who are 90 to 240 days after having received a primary living or cadaver renal allograft.
  • Patients maintained on a regimen of cyclosporine or tacrolimus and MMF since transplantation.
  • Capable of providing written informed consent.
  • No known contraindications to treatment with sirolimus.

Exclusion Criteria:

  • Pregnant or lactating.
  • Acute rejection within 90 days prior to study randomization.
  • More than one biopsy proven acute rejection episode prior to study randomization.
  • Previously received or are receiving an organ transplant other than kidney.
  • Receiving sirolimus prior to entry.
  • Severe diarrhea or other gastrointestinal disorders that may interfere with their ability to absorb oral medication.
  • Evidence of active systemic infection requiring antibiotics, or HIV, HCV, HBV infection.
  • History of malignancy in the past 5 years.
  • Require dialysis at the time of study entry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Composite endpoint of either acute rejection, biopsy proven calcineurin inhibitor toxicity, or failure of the estimated BSA indexed GFR by MDRD method to improve by 20% from time randomization to 12 months.

Secondary Outcome Measures

Outcome Measure
Renal allograft function at 6 and 12 months.
Incidence of biopsy proven acute rejection at 6 and 12 months.
Time to first rejection.
Total number of rejection episodes per patient.
Graft loss and patient death.
Incidence of treatment failure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 8, 2006

First Submitted That Met QC Criteria

September 8, 2006

First Posted (Estimate)

September 11, 2006

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STN INV INT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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