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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00275522

Enrollment

Registered

2006-01-12

Start date

2005-12-31

Completion date

2007-12-31

Last updated

2010-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant

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.

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.

Interventions

DRUGSirolimus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Calculated creatinine clearance at 12 months after transplantation.	—

Secondary

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026