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Clinical Trial
. 2005 Feb;24(2):166-9.
doi: 10.1016/j.healun.2003.09.043.

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

Affiliations
Clinical Trial

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

Diego H Delgado et al. J Heart Lung Transplant. 2005 Feb.

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.

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