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OpenTrials
Completed

NCT Number: NCT00275522

The Comparison of Three Different Immunosuppressant Regimens in Kidney Transplant 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.

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Key information

Conditions

Kidney Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sirolimus

Drug

Primary outcomes

  1. Calculated creatinine clearance at 12 months after transplantation.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jan 12, 2006
Registry last updated
Jan 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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