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Updated: Feb 8, 2026

Normothermic Ex Vivo Kidney Perfusion for the Preservation of Kidney Grafts prior to Transplantation
Published on: July 15, 2015
Effects of pre-transplant azithromycin administration on kidney graft function: study protocol for a double-blind
Gholamreza Mokhtari1, Mojtaba Teimoori2,3
1Transplant surgeon, Urology Research Center, Razi Hospital, Guilan University of Medical Sciences, Rasht, Guilan, Iran.
Background:
Kidney transplantation is the best strategy for the management of end-stage renal disease; however, the outcomes need to improve further. Macrolides show antimicrobial and anti-inflammatory properties in chronic diseases and intraoperatively, and can accumulate in tissues for extended periods. Therefore, theoretically, when administered to a donor and because of accumulation in the donor kidney, macrolides can cause graft immunomodulation and improve kidney transplantation outcomes.
Methods:
This study is a single-center, randomized clinical trial. A total of 60 kidney donors will be randomly allocated to the azithromycin or placebo group and treated with a single dose (1 g) of azithromycin or placebo, respectively, 1 day before surgery. Recruitment commenced in September 2016 and is expected to be completed by March 2018. The primary outcome is kidney graft function. The secondary outcomes include rejection rate, urinary tract infections in graft recipients, pain and systemic inflammatory response syndrome in live donors, and complications in both donors and recipients. Outcomes will be evaluated at baseline and every day in the first week after transplantation, as well as at 1 and 3 months post transplantation. Adverse reactions will be documented. If the efficacy of azithromycin in reducing adverse outcomes is confirmed, it would serve as an easy to use, economic intervention able to lower post-transplantation risks.
Discussion:
Short and mid-term analyses of blood and urine samples as well as immunological assays will facilitate a more in-depth analysis of the effects of azithromycin on transplantation outcomes.
Trial Registration:
Iranian Clinical Trial Registry, IRCT201606141853N11 , registered on September 5, 2016.
Insights
This study investigates azithromycin
Area of Science:
- Nephrology
- Transplantation Immunology
Background:
- Kidney transplantation is optimal for end-stage renal disease but requires outcome improvement.
- Macrolides, like azithromycin, possess anti-inflammatory properties and tissue accumulation potential.
- Theoretical benefits include graft immunomodulation and improved kidney transplant outcomes.
Purpose of the Study:
- To evaluate the efficacy of a single azithromycin dose in kidney donors.
- To assess the impact of azithromycin on kidney graft function and post-transplant outcomes.
- To explore azithromycin's role in reducing adverse events in kidney transplantation.
Main Methods:
- Single-center, randomized clinical trial with 60 kidney donors.
- Donors received a single 1g dose of azithromycin or placebo 1 day pre-surgery.
- Outcomes assessed include graft function, rejection rates, infections, and donor/recipient complications.
Main Results:
- This section is pending study completion and analysis.
- Further data collection and analysis are ongoing.
- The study aims to determine if azithromycin reduces adverse outcomes.
Conclusions:
- Short and mid-term analyses of biological samples are planned.
- Immunological assays will provide in-depth insights into azithromycin's effects.
- Confirmation of efficacy could establish azithromycin as an accessible intervention to lower post-transplantation risks.
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