Clinical Nephrology – Epidemiology – Clinical Trials

Kidney International (2005) 67, 1471–1475; doi:10.1111/j.1523-1755.2005.00224.x

Use of sirolimus and low-dose calcineurin inhibitor in lung transplant recipients with renal impairment: Results of a controlled pilot study

DAVID SHITRIT, RUTH RAHAMIMOV, SAHAR GIDON, ILANA BAKAL, ARIELLA BARGIL-SHITRIT, SAUTE MILTON and MORDECHAI R KRAMER

Pulmonary Institute; Department of Nephrology; and Department of Cardiothoracic Surgery, Rabin Medical Center, Beilinson Campus, Petah Tiqwa; Sackler Faculty of Medicine, Tel Aviv Univeristy, Tel Aviv, Israel; and Department of Internal Medicine, Shaare-Zedek Medical Center, Jerusalem, Israel

Correspondence: Prof M.R. Kramer, Pulmonary Institute, Rabin Medical Center, Beilinson Campus, Petah Tiqwa, Israel 49100. E-mail:davids3@clalit.org.il

Received 8 February 2004; Revised 7 June 2004; Re-revised 29 July 2004; Re-revised 9 September 2004; Accepted 12 October 2004.

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Abstract

Use of sirolimus and low-dose calcineurin inhibitor in lung transplant recipients with renal impairment: Results of a controlled pilot study.

Background

 

Renal failure induced by calcineurin-inhibitor agents is a common complication of lung transplantation. Sirolimus, a macrolide immunosuppressant with a distinct mechanism of action, may prevent renal failure but was found to have a high infectious and toxicity rate in the only relevant study conducted so far. The aim of the present prospective pilot study was to assess the benefit of sirolimus combined with low-dose calcineurin inhibitors in this patient population.

Methods

 

Sixteen lung transplant recipients with post-transplantation renal dysfunction were allocated to receive the standard immunosuppression regimen or a combination sirolimus/low-dose calcineurin-inhibitor regimen. Target trough levels of sirolimus were 4 to 8 ng/mL. Tacrolimus was tapered down to target trough levels of 4 to 8 ng/mL and cyclosporine to 80 to 120 ng/mL. Duration of follow-up was 18 months.

Results

 

At the end of follow-up, the sirolimus group showed a significant improvement in creatinine clearance (42.6 mL/min vs. 32.5 mL/min, P = 0.05), whereas the control group showed a significant reduction (32.3 mL/min vs. 40.3 mL/min, P = 0.02). The difference between the groups was statistically significant (P < 0.0001). Acute rejection episodes occurred in 2 patients in the sirolimus group and 1 patient in the control group (P = NS). Pneumonia developed in 6 study patients and 4 controls; all responded to antibiotics.

Conclusion

 

Sirolimus combined with low-dose calcineurin inhibitors appears to be a safe and effective alternative immunosuppressive therapy to sirolimus alone in lung transplant recipients with renal failure. Graft function is preserved, and infection and drug toxicity rates are low.

Keywords:

sirolimus, renal function, lung transplantation, calcineurin- inhibitor, rejection

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