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

NCT00275535 | Completed Phase 4 DMC

• 1 other identifier: 124-01
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Diseases

Keywords

kidney transplantation; immunosuppression; calcineurin inhibitor; sirolimus; chronic allograft nephropathy

Outcome Measures

Primary Outcomes (1)

• Glomerular filtration rate (GFR) (iothalamate clearance) at 12 months following transplantation

  Glomerular filtration rate (Iothalamate clearance) at 12 months following transplantation.

  12 months following transplantation

Secondary Outcomes (5)

• GFR (iothalamate clearance) at other time points

  24 months

• Other measures of renal function (serum creatinine, proteinuria and albuminuria)

  24 months

• Acute rejection both early and after tacrolimus withdrawal

  24 months

• Patient and graft survival

  24 months after transplantation

• Complications-especially hypertension, diabetes, dyslipidemia

  24 months

Study Arms (2)

Tacrolimus

ACTIVE COMPARATOR

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

Drug: Anti-thymocyte globulin; Drug: Mycophenolate mofetil; Drug: Prednisone; Drug: Tacrolimus

Sirolimus

ACTIVE COMPARATOR

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

Drug: Anti-thymocyte globulin; Drug: Mycophenolate mofetil; Drug: Prednisone; Drug: Sirolimus

Interventions

Anti-thymocyte globulin DRUG

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

Also known as: Thymoglobulin, Atgam

Sirolimus; Tacrolimus

Mycophenolate mofetil DRUG

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

Also known as: CellCept

Sirolimus; Tacrolimus

Prednisone DRUG

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

Also known as: Deltasone, Liquid Pred, Meticorten, Orasone, Prednicen-M, Prednicot, Sterapred, Sterapred DS

Sirolimus; Tacrolimus

Tacrolimus DRUG

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

Also known as: Prograf, Advagraf, Protopic

Tacrolimus

Sirolimus DRUG

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

Also known as: Rapamune

Sirolimus

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living and deceased donor kidney transplant recipients at the Mayo Clinic, Rochester, Minnesota

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator
• Genzyme, a Sanofi Company: collaborator
• Roche Pharma AG: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 18431244 RESULT

• 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.

  PMID: 16468960 RESULT

MeSH Terms

Conditions

Kidney Diseases

Interventions

Antilymphocyte Serum; thymoglobulin; Mycophenolic Acid; Prednisone; Tacrolimus; Sirolimus

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Macrolides; Lactones

Study Officials

• Mark D. Stegall, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 12, 2006
• Study Start: April 1, 2001
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2008
• Last Updated: December 8, 2011

Record last verified: 2011-12

Locations

US (1)