Bartter Syndrome Clinical Trial
Official title:
Acetazolamide (AZ) for Management of Refractory Hypokalemia Metabolic Alkalosis in Bartter Syndrome
In this prospective controlled cross over clinical trial, the investigators aim to evaluate the efficacy and safety of acetazolamide for the management of metabolic alkalosis in children with Bartter syndrome. Urine and blood electrolytes will be measured before and after acetazolamide treatment. The primary end point is a change in polyuria, hypokalemia, and metabolic alkalosis.
Bartter syndrome is a hereditary salt-loosing tubulopathy caused by several gene mutations
encoding the sodium reabsorption in the thick ascending limb of loop of Henle, with poor
response to treatment. The effects of inhibition of proximal tubular reabsorption of
bicarbonate by acetazolamide have not been previously studied in Batter patients.
The present study is designed to assess he efficacy and safety of acetazolamide for the
management of children with Bartter syndrome. The primary end point is change in polyuria,
hypokalemia, and metabolic alkalosis.
In this prospective observational crossover clinical trial, patients between ages 1 and 10
years with clinical diagnosis of Bartter syndrome (hypokalemia, metabolic alkalosis, normal
blood pressure, elevated urine chloride >20 milliequivalent per liter, high serum aldosterone
and plasma renin levels) will be enrolled in a 4- week clinical trial. After initial clinical
and laboratory evaluations, patients will receive acetazolamide 5.0 mg/kg orally as a single
daily dose and each patient will act as his/her own control. Renal electrolyte and 24-hour
urine output will be measured at baseline and after the 4 weeks acetazolamide treatment.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06065852 -
National Registry of Rare Kidney Diseases
|