Transplant Trial Watch

A Pilot Study of the Safety and Efficacy of Alkali Therapy on Vascular Function in Kidney Transplant Recipients.

Bohling, R., et al.

KI Reports 2021; 6(9): 2323-2330.

This study aimed to investigate whether alkali therapy improves vascular endothelial function in kidney transplant recipients (KTRs).

Participants were randomly assigned to receive either sodium bicarbonate therapy or placebo.

20 kidney transplant recipients.

The primary endpoint was change in brachial artery flow mediated dilation (FMD). Secondary endpoints included changes in serum interleukin-6, high-sensitivity C-reactive protein, pH, net acid excretion, urine ammonium excretion, and albumin-to-creatinine ratio.

18 weeks

CET Conclusions
The double-blind, cross-over, pilot randomised controlled trial tested the hypothesis that sodium bicarbonate therapy is safe and feasible, and improves flow-mediated dilation (FMD) in kidney transplant recipients (KTRs) when compared with placebo. Twenty KTRs who were at least 1 year posttransplant with an eGFR of ≥45 ml/min per 1.73 m2 and a serum bicarbonate level of 20-26 mEq/L were randomised according to a randomisation schedule to sodium bicarbonate or matching placebo for 8 weeks. Study drug compliance was high, around 95%. There was no statistically significant increase in FMD after 8 weeks of sodium bicarbonate therapy compared with placebo. The secondary outcome urinary ammonium excretion was significantly lower in the sodium bicarbonate group compared with the placebo group but all other secondary outcomes were similar between groups. There were no significant adverse events in either group and study medication was not stopped in any participant due to side effects. Sodium bicarbonate appeared to be safe and feasible but did not improve FMD in this underpowered study.

Jadad score

Data analysis
Per protocol analysis

Allocation concealment

Trial registration - NCT03428464

Funding source
Non-industry funded