6-year treatment follow-up with an extended-release alkaline formulation (Sibnayal^®) in primary distal renal tubular acidosis.

ABSTRACT:

Background

Distal renal tubular acidosis (dRTA) is a rare disease characterized by hyperchloremic metabolic acidosis affecting growth, bone and kidney health.

Methods

The aim of B22CS study was to evaluate long-term safety and efficacy (anthropometric/pubertal, tubular damages/kidney function, bone biomarkers, compliance assessments) of Sibnayal^®, a prolonged-release alkalinizing formulation with twice daily dosing, in children and adults with dRTA. All patients were previously included in the pivotal B21CS study, so were already receiving Sibnayal^® when included in B22CS open-label follow-up study.

Results

A total of 30 patients with primary dRTA (mean age:10.6 ± 6.0 years) entered this long-term study (average of 6 years). At inclusion, most pa

SUBMITTER: Bertholet-Thomas A 

PROVIDER: S-EPMC12351860 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature