Comparison of Sirolimus to Tacrolimus for Long Term Therapy in Kidney Transplant With no Steroids
Randomized Trial of Thymoglobulin Induction, Initial Tacrolimus, and Mycophenolate Mofetil Therapy With Steroid Avoidance in Primary Kidney Transplant Recipients Followed by Continued Tacrolimus/Mycophenolate Mofetil Therapy vs. Sirolimus/ Mycophenolate Mofetil Therapy
2 other identifiers
interventional
177
1 country
1
Brief Summary
Kidney transplant patients will be treated with Thymoglobulin (5 days), tacrolimus (Prograf), and mycophenolate mofetil (Cellcept) from the time of transplant. They will only receive steroids for 4 days and no prednisone after that. At 1 month, they will have a kidney biopsy and if it is ok, patients will be treated long term with either continued tacrolimus/mycophenolate mofetil or be switched to sirolimus (Rapamune)/mycophenolate mofetil. This will be done randomly in a manner similar to flipping a coin. The investigators are trying to determine if after the initial therapy patients can stay off steroids long term and get better kidney function if they are treated with sirolimus compared to tacrolimus. Patients will be followed for 3 years and will repeat kidney biopsies at 1 and 2 years after transplant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2005
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedJuly 31, 2012
July 1, 2012
3.3 years
September 12, 2005
July 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Renal function
1 year
Secondary Outcomes (5)
Renal function
2 years
Transplant biopsy histology
2 years
Patient and graft survival
2years
Acute rejection rate
1 month
Number of patients steroid free
1 year
Interventions
10 mg oral loading dose followed by 5 mg/day. Measure Sirolimus level weekly and adjust to level of 10-15 ng/ml.
Eligibility Criteria
You may qualify if:
- Primary deceased or living donor renal transplant recipients
- Re-transplant recipients for which the first kidney transplant was lost for technical reasons with no sensitization (panel-reactive antibody \[PRA\] \< 20%) or 1st lost due to recurrent disease, that is not steroid responsive.
- Age \> 18
- Negative pregnancy test if female and of childbearing age. In addition, females of childbearing age must agree to use effective contraception for the duration of the study.
- Patient must sign informed consent prior to transplant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
- Genzyme, a Sanofi Companycollaborator
- Raymond Heilmancollaborator
Study Sites (1)
Mayo Clinic
Jacksonville, Florida, 32224, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas A. Gonwa, M.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
June 1, 2005
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
July 31, 2012
Record last verified: 2012-07