Variability in the reporting of renal function endpoints in immunosuppression trials in renal transplantation: time for consensus?

Journal article

Early measures of graft function are increasingly used to assess efficacy in clinical trials of kidney transplant immunosuppression. This study aimed to assess the variability and quality of reporting of these endpoints in contemporary trials. Data regarding renal function endpoints were extracted from 213 reports from randomised controlled trials comparing immunosuppressive interventions in renal transplant recipients published between 2010 and 2014. 174 (81.7%) reports included a measure of renal function; in 44 (20.7%) this was the primary endpoint. 103 manuscripts (48.4%) reported serum creatinine, 142 (66.6%) reported eGFR and 26 (12.2%) reported measured GFR. Formulas used for GFR estimation were MDRD (42.3%), Cockroft Gault (23.5%), Nankivell (15.0%) and CKD-EPI (0.9%). 6 studies (2.8%) did not report the formula used to estimate GFR. 13.9% of endpoints had missing data. In 10 studies, disagreement was found in the significance of findings using different measures of renal function. There is a great deal of variability in the reporting of renal function endpoints, with a significant proportion of studies using under-performing or inappropriate estimates. There is a need for consensus as to the best tool for monitoring and reporting renal function post-transplant, and in particular for use in clinical trials and registries.

Authors: Knight, S; Hussain, S

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: Wiley
• Journal: Clinical Transplantation
• Volume: 30
• Issue: 12
• Pages: 1584–1590
• Publication date: 2016-11-01
• Acceptance date: 2016-10-11
• DOI: 10.1111/ctr.12861
• EISSN: 1399-0012
• ISSN: 0902-0063
• Keywords: Renal Transplant; Clinical Trials; Quality; Graft Function; Immunosuppression; Endpoints