Use of basiliximab and cyclosporine in heart transplant patients with pre-operative renal dysfunction

J Heart Lung Transplant. 2005 Feb;24(2):166-9. doi: 10.1016/j.healun.2003.09.043.

Abstract

Background: The combined use of basiliximab and cyclosporine in heart transplantation is under investigation. In this study we sought to evaluate the safety and efficacy of basiliximab and delayed initiation of cyclosporine in patients with renal dysfunction undergoing heart transplantation.

Methods: Seven patients (Group A) with renal dysfunction (creatinine > or =200 micromol/liter) received induction therapy with basiliximab. Seven patients (Group B) with renal dysfunction comprised the control group and received induction therapy with rabbit anti-thymocyte serum. Cyclosporine was initiated 5 days post-transplant in Group A and within 5 days post-transplant in Group B.

Results: All patients were alive at the end of the 6-month follow-up. In Group A, mean pre-transplant creatinine was 243 +/- 48 micromol/liter, at 1 week post-transplant was 180 +/- 39 micromol/liter (p = 0.02), at 1 month was 166 +/- 57 micromol/liter (p = 0.019), at 3 months was 182 +/- 25 micromol/liter (p = 0.01) and at 6 months was 179 +/- 45 micromol/liter (p = 0.024). In Group B, mean pre-transplant creatinine was 242 +/- 41 micromol/liter, at 1 week was 140 +/- 35 micromol/liter (p = 0.0003), at 1 month was 143 +/- 38 mumol/liter (p = 0.0005), at 3 months was 138 +/- 37 micromol/liter (p = 0.0003) and at 6 months was 154 +/- 30 micromol/liter (p = 0.0006). There were no differences in renal dysfunction between both groups at 1 week (p = 0.069), 1 month (p = 0.39) or 6 months (p = 0.24) post-HT. Fewer episodes of cellular rejection were identified in Group B within the 6-month follow-up period.

Conclusions: The use of induction therapy either with basiliximab or rabbit anti-thymocyte serum in patients with pre-operative renal dysfunction confers renal protection early and up to 6 months post-transplant. Delayed initiation of cyclosporine might be considered to provide additional renal protection.

Publication types

  • Clinical Trial
  • Comparative Study

MeSH terms

  • Adult
  • Antibodies, Monoclonal / therapeutic use*
  • Antilymphocyte Serum / therapeutic use
  • Basiliximab
  • Biomarkers / blood
  • Creatinine / blood
  • Cyclosporine / therapeutic use*
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Follow-Up Studies
  • Graft Rejection / etiology
  • Graft Rejection / metabolism
  • Heart Failure / metabolism
  • Heart Failure / surgery
  • Heart Transplantation*
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Kidney Diseases / complications*
  • Kidney Diseases / mortality
  • Male
  • Middle Aged
  • Postoperative Complications / etiology
  • Postoperative Complications / metabolism
  • Preoperative Care
  • Recombinant Fusion Proteins / therapeutic use*
  • Renal Insufficiency / prevention & control
  • Statistics as Topic
  • Stroke Volume / drug effects
  • Stroke Volume / physiology
  • Time Factors
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal
  • Antilymphocyte Serum
  • Biomarkers
  • Immunosuppressive Agents
  • Recombinant Fusion Proteins
  • Cyclosporine
  • Basiliximab
  • Creatinine