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

Kidney Transplant Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275522
• Other study ID #: 1302-04
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2006
• Last updated: January 19, 2010
• Start date: December 2005
• Est. completion date: December 2007

Study information

• Verified date: January 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Drug:
• Sirolimus

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculated creatinine clearance at 12 months after transplantation.
Secondary	Calculated creatinine clearance at 26, 78, and 104 weeks post transplantation.
Secondary	Serum creatinine at 26, 52, 78, and 104 weeks post transplantation.
Secondary	Subject and graft survival at 26, 52, 78, and 104 weeks post transplantation.
Secondary	Incidence and severity of biopsy-confirmed acute rejection at 26, 52, 78, and 108 weeks post transplantation.
Secondary	Severity of rejection, including histological grade of the first acute rejection episode.