The Comparison of Three Different Immunosuppressant Regimens in Kidney Transplant Recipients.

A Randomized Open-label Study to Compare the Safety and Efficacy of Two Different Sirolimus Regimens With a Tacrolimus + Mycophenolate Mofetil Regimen in De Novo Renal Allograft Recipients.

The study is being done to compare the safety and effects (good and bad) of three different combinations of immunosuppression drugs used by kidney transplant recipients while also looking at their kidney function.

Study Overview

• Status: Completed
• Conditions: Kidney Transplant
• Intervention / Treatment: Drug: Sirolimus

Detailed Description

This is an open-label, randomized, comparative, multinational study. The study will be looking at the kidney function of kidney transplant recipients, while also comparing the safety and the effects (good and bad) of three different combinations of immunosuppression drugs in combination with prednisone, following treatment with Daclizumab (Zenapax). The three combinations are; (1) sirolimus and tacrolimus followed by the withdrawal of tacrolimus after three months; (2) sirolimus and mycophenolate mofetil (MMF); and (3) tacrolimus and MMF. The participants will be required to return to throughout the next 24 months following their transplant for physical exams, chest x-ray, blood, and urine tests. Participants will be put into one of three groups, and receive the study drugs starting on the day of transplant. Due to some drugs affecting the drug levels of sirolimus, participants need to agree not to take any new drugs during the study unless approved by the study doctor.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Participants must be at least between the ages of 18 and 75, and will be receiving their first or second kidney transplant.

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Calculated creatinine clearance at 12 months after transplantation.

Secondary Outcome Measures

Outcome Measure
Calculated creatinine clearance at 26, 78, and 104 weeks post transplantation.
Serum creatinine at 26, 52, 78, and 104 weeks post transplantation.
Subject and graft survival at 26, 52, 78, and 104 weeks post transplantation.
Incidence and severity of biopsy-confirmed acute rejection at 26, 52, 78, and 108 weeks post transplantation.
Severity of rejection, including histological grade of the first acute rejection episode.

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: January 10, 2006
• First Submitted That Met QC Criteria: January 10, 2006
• First Posted (Estimate): January 12, 2006

Study Record Updates

• Last Update Posted (Estimate): January 20, 2010
• Last Update Submitted That Met QC Criteria: January 19, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: 1302-04