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The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients

NCT ID: NCT00275535

Last Updated: 2011-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Kidney Diseases

Keywords

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kidney transplantation immunosuppression calcineurin inhibitor sirolimus chronic allograft nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tacrolimus

Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone.

Group Type ACTIVE_COMPARATOR

Anti-thymocyte globulin

Intervention Type DRUG

Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)

Mycophenolate mofetil

Intervention Type DRUG

Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance

Prednisone

Intervention Type DRUG

Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92

Tacrolimus

Intervention Type DRUG

Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay)

Sirolimus

Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone.

Group Type ACTIVE_COMPARATOR

Anti-thymocyte globulin

Intervention Type DRUG

Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)

Mycophenolate mofetil

Intervention Type DRUG

Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance

Prednisone

Intervention Type DRUG

Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92

Sirolimus

Intervention Type DRUG

Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml

Interventions

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Anti-thymocyte globulin

Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)

Intervention Type DRUG

Mycophenolate mofetil

Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance

Intervention Type DRUG

Prednisone

Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92

Intervention Type DRUG

Tacrolimus

Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay)

Intervention Type DRUG

Sirolimus

Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml

Intervention Type DRUG

Other Intervention Names

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Thymoglobulin Atgam CellCept Deltasone Liquid Pred Meticorten Orasone Prednicen-M Prednicot Sterapred Sterapred DS Prograf Advagraf Protopic Rapamune

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role collaborator

Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Mark D. Stegall, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 18431244 (View on PubMed)

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.

Reference Type RESULT
PMID: 16468960 (View on PubMed)

Other Identifiers

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124-01

Identifier Type: -

Identifier Source: org_study_id