A multicenter pilot study of early (4-day) steroid cessation in renal transplant recipients under simulect, tacrolimus and sirolimus

Am J Transplant. 2005 Jan;5(1):157-66. doi: 10.1111/j.1600-6143.2004.00655.x.

Abstract

This study presents the first prospective multicenter study assessing sirolimus-based immunosuppression with early (4-day) corticosteroid withdrawal (CSWD) in renal transplantation. Immunosuppression included: anti-IL-2 receptor antibody and tacrolimus/sirolimus. Inclusion criteria included adult primary recipients. Exclusion criteria included: (i) African Americans, (ii) current PRA >50%, (iii) multiple organ transplants, (iv) WBC < 3000 cells/microL and (v) fasting hypercholesterolemia/hypertriglyceridemia. The primary endpoints were acute rejection and the proportion of patients off corticosteroids. Seventy-seven patients were enrolled: mean age of 49.7 +/- 12 years. Transplants included: cadaveric (26%) and living donor (74%). Patient and graft survival were 100%. Biopsy proven acute rejection occurred in 13%; presumptive rejection in 10.5%. Banff grades included: IA (seven patients), IB (one patient), IIA (one patient) and IIB (one patient). Renal function at 1 year: serum creatinine (1.18 +/- 0.06 mg/dL). Mean weight gain was minimal at 1 year: 3 +/- 2 kg/patient. Mild increases in total, LDL and HDL cholesterol were observed and new antilipid agent use occurred in 26 patients. In conclusion, early CSWD under tacrolimus/sirolimus-based immunosuppression in selected, low-risk renal transplant recipients provides: (i) excellent patient and graft survival, (ii) good renal function, (iii) reduced hyperlipidemia and antilipid agent use and (iv) low acute rejection rates.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenal Cortex Hormones / therapeutic use
  • Adult
  • Antibodies, Monoclonal / therapeutic use*
  • Basiliximab
  • Biopsy
  • Blood Pressure
  • Body Weight
  • Cadaver
  • Cardiovascular System
  • Cholesterol, HDL / blood
  • Cholesterol, LDL / blood
  • Creatinine / blood
  • Female
  • Graft Rejection
  • Graft Survival
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / therapeutic use*
  • Infections / etiology
  • Kidney Transplantation / methods*
  • Living Donors
  • Male
  • Middle Aged
  • Pilot Projects
  • Recombinant Fusion Proteins / therapeutic use*
  • Risk Factors
  • Sirolimus / therapeutic use*
  • Steroids / therapeutic use*
  • Tacrolimus / therapeutic use*
  • Time Factors
  • Treatment Outcome

Substances

  • Adrenal Cortex Hormones
  • Antibodies, Monoclonal
  • Cholesterol, HDL
  • Cholesterol, LDL
  • Immunosuppressive Agents
  • Recombinant Fusion Proteins
  • Steroids
  • Basiliximab
  • Creatinine
  • Sirolimus
  • Tacrolimus