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Sodium Bicarbonate for Kidney Transplant Recipients With Metabolic Acidosis

A study shows that the decline in estimated glomerular filtration rate (GFR) was not slowed over a 2-year period in adult kidney transplant recipients when they received sodium bicarbonate to correct metabolic acidosis. “Treatment with sodium bicarbonate should not be generally recommended to preserve estimated GFR (a surrogate marker for graft function) in kidney transplant recipients with chronic kidney disease who have metabolic acidosis,” the authors conclude.

The multicenter, randomized, single-blind, placebo-controlled, phase 3 Preserve-Transplant Study was conducted at 3 university hospitals in Switzerland. Adult (aged ≥18 years) male and female long-term kidney transplant recipients were recruited, provided they were at least 1 year post-transplant and had an estimated GFR of 15–89 mL/min per 1.73 m2, stable allograft function in the last 6 months before study inclusion (<15% change in serum creatinine), and a serum bicarbonate of 22 mmol/L or less. Participants were randomized to oral sodium bicarbonate 1.5–4.5 g per day or matching placebo for 2 years.

The study assessed a primary endpoint of the estimated GFR slope over the 24-month treatment phase, with these results: “The calculated yearly estimated GFR slopes over the 2-year treatment period were a median –0.722 mL/min per 1.73 m2 (IQR –4.081 to 1.440) and mean –1.862 mL/min per 1.73 m2 (SD 6.344) per year in the placebo group versus median –1.413 mL/min per 1.73 m2 (IQR –4.503 to 1.139) and mean –1.830 mL/min per 1.73 m2 (SD 6.233) per year in the sodium bicarbonate group (Wilcoxon rank sum test P = 0.51; Welch t-test P = 0.97). The mean difference was 0.032 mL/min per 1.73 m2 per year (95% CI –1.644 to 1.707). There were no significant differences in estimated GFR slopes in a subgroup analysis and a sensitivity analysis confirmed the primary analysis. Although the estimated GFR slope did not show a significant difference between the treatment groups, treatment with sodium bicarbonate effectively corrected metabolic acidosis by increasing serum bicarbonate from 21.3 mmol/L (SD 2.6) to 23.0 mmol/L (2.7) and blood pH from 7.37 (SD 0.06) to 7.39 (0.04) over the 2-year treatment period. Adverse events and serious adverse events were similar in both groups. Three study participants died. In the placebo group, one (1%) patient died from acute respiratory distress syndrome due to SARS-CoV-2 and one (1%) from cardiac arrest after severe dehydration following diarrhoea with hypotension, acute kidney injury, and metabolic acidosis. In the sodium bicarbonate group, one (1%) patient had sudden cardiac death.”

Source: Lancet