Transplant Trial Watch

Albuminuria and Allograft Failure, Cardiovascular Disease Events, and All-Cause Death in Stable Kidney Transplant Recipients: A Cohort Analysis of the FAVORIT Trial.

Weiner, D. E., et al.

American Journal of Kidney Diseases 2019; 73(1): 51-61.

This study was a post hoc analysis of the Folic Acid for Vascular Outcomes Reduction in Transplantation (FAVORIT) trial, which was a large randomized trial that aimed to examine the role of vitamin B6, vitamin B12, and high dose folic acid in reducing cardiovascular disease (CVD) events in kidney transplant recipients. The primary objective of this analysis was to evaluate the association between baseline urine albumin-creatinine ratio (ACR) and outcomes (graft failure, CVD and death from all causes).

Participants were randomized to a multivitamin that contained either a high dose or low-dose vitamin B6, vitamin B12 and folic acid.

Kidney transplant recipients.

The primary endpoints of this study were time to graft failure and time to a CVD event. The secondary endpoints were mortality (from all causes) and a composite all-cause mortality and graft failure.

3.9 years (mean)

CET Conclusions
This post-hoc observational analysis in the FAVORIT trial population investigates the association between baseline albuminuria (measured by the albumin-creatinine ration; ACR) and incidence of graft loss, death and cardiovascular events in stable renal transplant recipients. The authors find associations between baseline ACR and risk of graft loss, death and CVD events that are stronger with higher baseline ACR. This is an interesting finding that confirms previous observations in native kidney disease. There are some limitations – notably a relatively short follow-up (4 years) and single baseline ACR measurement. Whether intervention to modify proteinuria early on would have any impact on outcome is uncertain and would require prospective study.

Quality notes
Previously assessed-QA not necessary

Trial registration - NCT00064753

Funding source
Non-industry funded