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NDT Advance Access originally published online on March 19, 2004
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Nephrol Dial Transplant (2004) 19: 1613-1617
Nephrol Dial Transplant Vol. 19 No. 6 © ERA-EDTA 2004; all rights reserved

Original Article

Co-administration of ketoconazole to tacrolimus-treated kidney transplant recipients: a prospective randomized study

Khalid Farouk El-Dahshan, Mohamed Adel Bakr, Ahmed Farouk Donia, Ali El-Sayed Badr and Mohamed Abdel-Kader Sobh

Nephrology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt

Correspondence and offprint requests to: Professor Dr Mohamed A. Sobh, MD, FACP, Nephrology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt. Email: sobh10{at}yahoo.com

Background. Since the introduction of calcineurin inhibitors, there has been a significant improvement in the results of solid organ transplantation, including graft and patient survival. However, high cost, chronic nephrotoxicity and other side effects stand as major challenges for long-term use of these drugs. The long-term safety and financial benefits of the combination ketoconazole–cyclosporine previously studied. However, data about the effect of the addition of ketoconazole addition to tacrolimus-treated patients are scarce. Therefore, this study was conducted to evaluate the safety and financial impact of that combination.

Methods. The subjects of this work included 70 live-donor stable kidney transplant recipients receiving tacrolimus. Their age ranged from 16 to 45 years. Among them, 54 were males and 16 were females. All of them were 6 months or more post-transplantation. Patients were randomly divided into two equal groups. Group I patients initially received ketoconazole 100 mg/day in addition to their usual treatment, while group II patients were considered a control. Patients were followed-up for 6 months.

Results. Concomitant ketoconazole–tacrolimus resulted in marked reduction of tacrolimus dose (by 58.7%) and cost (by 56.9%). It also resulted in significant improvement in graft function and fungal skin infection, in addition to a decrease of gastrointestinal episodes and hospitalization.

Conclusion. We conclude that ketoconazole–tacrolimus combination in kidney transplant recipients is safe, has outstanding impact on treatment costs and improves patient and graft outcome.

Keywords: ketoconazole; kidney transplantation; tacrolimus


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