Back to resultsThe Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients
Primary Purpose
Kidney Diseases
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Anti-thymocyte globulin
Mycophenolate mofetil
Prednisone
Tacrolimus
Sirolimus
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Diseases focused on measuring kidney transplantation, immunosuppression, calcineurin inhibitor, sirolimus, chronic allograft nephropathy
Eligibility Criteria
Inclusion Criteria: Living and deceased donor kidney transplant recipients at the Mayo Clinic, Rochester, Minnesota Exclusion Criteria: Patients with type 1 diabetes less than 50 years of age who receive a living donor kidney transplant followed by a pancreas transplant Pediatric patients (<18 years of age) Multi-organ transplants (e.g., kidney-pancreas, kidney-liver) ABO-incompatible or positive crossmatch recipients (ABO incompatibility is an immune system reaction that occurs when blood from two different and incompatible blood types are mixed together.) Patients with severe hyperlipidemia (serum cholesterol >350 mg/dl or serum triglycerides >500 mg/dl Patients with severe leukopenia (White Blood Cell count [WBC]<3000 10^3/ml) Patients unwilling to return to the transplant center for late follow-up visits Body mass index (BMI) ≥ 32 with incisional problems post transplant (as determined by renal transplant surgeon
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tacrolimus
Sirolimus
Arm Description
Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone.
Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone.
Outcomes
Primary Outcome Measures
Glomerular filtration rate (GFR) (iothalamate clearance) at 12 months following transplantation
Glomerular filtration rate (Iothalamate clearance) at 12 months following transplantation.
Secondary Outcome Measures
GFR (iothalamate clearance) at other time points
Other measures of renal function (serum creatinine, proteinuria and albuminuria)
Acute rejection both early and after tacrolimus withdrawal
Patient and graft survival
Complications-especially hypertension, diabetes, dyslipidemia
Full Information
NCT ID
NCT00275535
First Posted
January 10, 2006
Last Updated
December 6, 2011
Sponsor
Mayo Clinic
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer, Genzyme, a Sanofi Company, Roche Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT00275535
Brief Title
The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients
Official Title
A Prospective, Randomized Trial of Calcineurin-Inhibitor Withdrawal in Renal Allograft Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer, Genzyme, a Sanofi Company, Roche Pharma AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.
Detailed Description
The aim of this study was to compare the complete avoidance of calcineurin inhibitors (CI) using a sirolimus-based immunosuppressive regimen to a tacrolimus-based regimen in kidney transplantation. This study was a prospective open-label trial randomizing patients to receive tacrolimus, mycophenolate mofetil and prednisone or sirolimus, mycophenolate mofetil and prednisone. All patients received antithymocyte globulin induction. All rejection episodes were proven by biopsy. The hypothesis was that CI free immunosuppression after kidney transplantation will lead to an increase in glomerular filtration rate (GFR) at one year after kidney transplantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases
Keywords
kidney transplantation, immunosuppression, calcineurin inhibitor, sirolimus, chronic allograft nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tacrolimus
Arm Type
Active Comparator
Arm Description
Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone.
Arm Title
Sirolimus
Arm Type
Active Comparator
Arm Description
Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone.
Intervention Type
Drug
Intervention Name(s)
Anti-thymocyte globulin
Other Intervention Name(s)
Thymoglobulin, Atgam
Intervention Description
Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil
Other Intervention Name(s)
CellCept
Intervention Description
Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Deltasone, Liquid Pred, Meticorten, Orasone, Prednicen-M, Prednicot, Sterapred, Sterapred DS
Intervention Description
Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Prograf, Advagraf, Protopic
Intervention Description
Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay)
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
Rapamune
Intervention Description
Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml
Primary Outcome Measure Information:
Title
Glomerular filtration rate (GFR) (iothalamate clearance) at 12 months following transplantation
Description
Glomerular filtration rate (Iothalamate clearance) at 12 months following transplantation.
Time Frame
12 months following transplantation
Secondary Outcome Measure Information:
Title
GFR (iothalamate clearance) at other time points
Time Frame
24 months
Title
Other measures of renal function (serum creatinine, proteinuria and albuminuria)
Time Frame
24 months
Title
Acute rejection both early and after tacrolimus withdrawal
Time Frame
24 months
Title
Patient and graft survival
Time Frame
24 months after transplantation
Title
Complications-especially hypertension, diabetes, dyslipidemia
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Living and deceased donor kidney transplant recipients at the Mayo Clinic, Rochester, Minnesota
Exclusion Criteria:
Patients with type 1 diabetes less than 50 years of age who receive a living donor kidney transplant followed by a pancreas transplant
Pediatric patients (<18 years of age)
Multi-organ transplants (e.g., kidney-pancreas, kidney-liver)
ABO-incompatible or positive crossmatch recipients (ABO incompatibility is an immune system reaction that occurs when blood from two different and incompatible blood types are mixed together.)
Patients with severe hyperlipidemia (serum cholesterol >350 mg/dl or serum triglycerides >500 mg/dl
Patients with severe leukopenia (White Blood Cell count [WBC]<3000 10^3/ml)
Patients unwilling to return to the transplant center for late follow-up visits
Body mass index (BMI) ≥ 32 with incisional problems post transplant (as determined by renal transplant surgeon
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D. Stegall, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18431244
Citation
Dean PG, Grande JP, Sethi S, Park WD, Griffin MD, Cosio FG, Larson TS, Stegall MD. Kidney transplant histology after one year of continuous therapy with sirolimus compared with tacrolimus. Transplantation. 2008 Apr 27;85(8):1212-5. doi: 10.1097/TP.0b013e31816a8ae6.
Results Reference
result
PubMed Identifier
16468960
Citation
Larson TS, Dean PG, Stegall MD, Griffin MD, Textor SC, Schwab TR, Gloor JM, Cosio FG, Lund WJ, Kremers WK, Nyberg SL, Ishitani MB, Prieto M, Velosa JA. Complete avoidance of calcineurin inhibitors in renal transplantation: a randomized trial comparing sirolimus and tacrolimus. Am J Transplant. 2006 Mar;6(3):514-22. doi: 10.1111/j.1600-6143.2005.01177.x.
Results Reference
result
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials
Learn more about this trial
The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients
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