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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00374647
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : June 6, 2008
Information provided by:
University of Cincinnati

Brief Summary:
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 or disease Intervention/treatment Phase
Primary Renal Allograft Drug: mycophenolate mofetil Drug: sirolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
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)
Study Start Date : March 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. Renal allograft function at 6 and 12 months.
  2. Incidence of biopsy proven acute rejection at 6 and 12 months.
  3. Time to first rejection.
  4. Total number of rejection episodes per patient.
  5. Graft loss and patient death.
  6. Incidence of treatment failure.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00374647

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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
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Principal Investigator: Steve Woodle, MD University of Cincinnati
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Responsible Party: E. Steve Woodle, MD, FACS, University of Cincinnati Identifier: NCT00374647    
Other Study ID Numbers: STN INV INT
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: June 6, 2008
Last Verified: June 2008
Keywords provided by University of Cincinnati:
Additional relevant MeSH terms:
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Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs