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

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ClinicalTrials.gov Identifier: NCT00275522
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : January 20, 2010
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Drug: Sirolimus Phase 4

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  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : December 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus




Primary Outcome Measures :
  1. Calculated creatinine clearance at 12 months after transplantation.

Secondary Outcome Measures :
  1. Calculated creatinine clearance at 26, 78, and 104 weeks post transplantation.
  2. Serum creatinine at 26, 52, 78, and 104 weeks post transplantation.
  3. Subject and graft survival at 26, 52, 78, and 104 weeks post transplantation.
  4. Incidence and severity of biopsy-confirmed acute rejection at 26, 52, 78, and 108 weeks post transplantation.
  5. Severity of rejection, including histological grade of the first acute rejection episode.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria
Participants must be at least between the ages of 18 and 75, and will be receiving their first or second kidney transplant.

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 ClinicalTrials.gov identifier (NCT number): NCT00275522


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Mark D. Stegall, M.D. Mayo Clinic

Responsible Party: Mark D. Stegall, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00275522     History of Changes
Other Study ID Numbers: 1302-04
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs