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

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00275522
First received: January 10, 2006
Last updated: January 19, 2010
Last verified: January 2010
History of Changes

January 10, 2006
January 19, 2010
December 2005
December 2007   (final data collection date for primary outcome measure)
Calculated creatinine clearance at 12 months after transplantation.
Same as current
Complete list of historical versions of study NCT00275522 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplant
Drug: Sirolimus
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2007
December 2007   (final data collection date for primary outcome measure)

Participants must be at least between the ages of 18 and 75, and will be receiving their first or second kidney transplant.
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00275522
1302-04
Not Provided
Mark D. Stegall, M.D., Mayo Clinic
Mayo Clinic
Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Mark D. Stegall, M.D. Mayo Clinic
Mayo Clinic
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP