Findings From DIALIZE China Reported

The DIALIZE China (Reduce Incidence of Predialysis Hyperkalemia With Sodium Zirconium Cyclosilicate in Chinese Subjects) study was designed to evaluate the use of sodium zirconium cyclosilicate (SZC) for the management of hyperkalemia in patients in China undergoing hemodialysis (NCT04217590). Zhaohui Ni, MD, and colleagues reported results of the double-blind study.

The study cohort included adults in China with kidney failure and predialysis hyperkalemia, (predialysis serum potassium concentration >5.4 mmol/L after the long interdialytic interval [LIDI] and >5.0 mmol/L after ≥1 short interdialytic interval) who were receiving hemodialysis three times weekly. Participants were randomized to placebo or SZC 5 grams once daily on nondialysis days.

Doses were titrated toward maintaining normokalemia for 4 week (titration period) in 5 gram increments up to 15 grams. The primary efficacy outcome of interest was the proportion of responders during the 4-week valuation period following the titration period. Responders were defined as those with a predialysis serum potassium concentration of 4.0 to 5.0 mmol/L for at least three of four hemodialysis visits following the LIDI who did not require urgent rescue therapy.

A total of 143 adults were randomized to SZC (n=67) or placebo (n=67). Mean age was 55 years. The proportion of responders was significantly higher in the SZC group than in the placebo group: 37.3% versus 10.4%, respectively (estimated odds ratio [OR], 5.10; 95% CI, 1.90-15.15; P<.001). The probability of all predialysis serum potassium concentrations being 3.5 to 5.5 mmol/L was significantly higher with SZC versus placebo (estimated OR, 6.41; 95% CI, 2.71-15.12; P<.001).

The proportion of patients who achieved a serum potassium concentration of 3.5 to 5.5 mmol/L on at least three of four LIDI visits during evaluation was higher in the SZC group than in the placebo group (73.1% vs 29.9%, respectively). Serious adverse events were reported in 9.1% and 11.9% of patients in the SZC group and placebo group, respectively.

In conclusion, the researchers said, “SZC treatment for predialysis hyperkalemia is effective and well tolerated in Chinese patients with kidney failure receiving hemodialysis.”

Source: Clinical Therapeutics