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 DE, Park M, et al.

Am J Kidney Dis. 2018; [record in progress].


Aims
To determine the relationship of albuminuria with cardiovascular and kidney outcomes in kidney transplant recipients.

Interventions
Participants in the FAVORIT Trial were randomly assigned to receive either a standard multivitamin with high doses of folic acid, vitamin B6, and vitamin B12 or a multivitamin containing low doses of vitamin B6 and vitamin B12 without folic acid. The two study treatment groups were combined for this post hoc cohort analysis.

Participants
3511 stable kidney transplant recipients with elevated homocysteine levels were included. 599 participants were excluded due to missing outcome data.

Outcomes
The primary outcomes were time to allograft failure and time to a cardiovascular disease (CVD) event. Secondary outcomes included all-cause mortality and a composite of allograft failure and all-cause mortality.

Follow-up
Up to 5.5 years.

CET Conclusions
This is an interesting post-hoc analysis of the FAVORIT study that combines both study arms to analyse the relationship between albuminuria (urine albumin:creatinine ratio, ACR) and cardiovascular disease and overall graft survival. The ACR was taken at the time of enrolment in the study. A multivariate analysis was undertaken, incorporating multiple relevant factors from a large population of patients (N=3,511). Albumin:creatinine ratio (ACR) 30-299mg/g and ≥300mg/g were associated with a significantly increased hazard ratio for graft failure (HR=3.3 and HR=9.9) compared to ACR<10mg/g. Higher ACR was also significantly associated with cardiovascular events and all-cause mortality. The association between ACR and outcomes in kidney transplant recipients is similar to that in the general population.

Jadad score
5

Data analysis
Per protocol analysis

Allocation concealment
Yes

Quality notes
Previously assessed as Bostom AG, Carpenter MA, Kusek JW, et al. Circulation;123:1763-70, 2011.

Trial registration
ClinicalTrials.gov - NCT00064753

Funding source
Non-industry funded