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

This study has been completed.
Information provided by:
University of Cincinnati Identifier:
First received: September 8, 2006
Last updated: June 5, 2008
Last verified: June 2008
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.

Condition Intervention Phase
Primary Renal Allograft Drug: mycophenolate mofetil Drug: sirolimus Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 17
Study Start Date: March 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00374647

United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45267
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Principal Investigator: Steve Woodle, MD University of Cincinnati
  More Information

Responsible Party: E. Steve Woodle, MD, FACS, University of Cincinnati Identifier: NCT00374647     History of Changes
Other Study ID Numbers: STN INV INT
Study First Received: September 8, 2006
Last Updated: June 5, 2008

Keywords provided by University of Cincinnati:

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Calcineurin Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017