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

This study has been completed.
Sponsor:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00374647
First received: September 8, 2006
Last updated: June 5, 2008
Last verified: June 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374647

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

No publications provided

Responsible Party: E. Steve Woodle, MD, FACS, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00374647     History of Changes
Other Study ID Numbers: STN INV INT
Study First Received: September 8, 2006
Last Updated: June 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Renal
Kidney
Transplant

Additional relevant MeSH terms:
Sirolimus
Mycophenolic Acid
Mycophenolate mofetil
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014