Acetazolamide (AZ) for Management of Alkalosis in Bartter Syndrome

• Sponsor: Tehran University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03847571
• Collaborator: (none)
• Enrollment: 20
• Locations: 4
• Anticipated Duration (Months): 11.6
• Patients Per Site: 5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bartter Syndrome	Drug: Acetazolamide

Detailed Description

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• Official Title: Acetazolamide (AZ) for Management of Refractory Hypokalemia Metabolic Alkalosis in Bartter Syndrome
• Actual Study Start Date: Jan 10, 2019
• Anticipated Primary Completion Date: Oct 30, 2019
• Anticipated Study Completion Date: Dec 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Acetazolamide Oral administration of acetazolamide 5 mg/kg/day for 4 weeks	Drug: Acetazolamide; Correction of metabolic alkalosis by inhibition of the filtered bicarbonate load reabsorption in the proximal tubules using acetazolamide (AZ)

Outcome Measures

Primary Outcome Measures

1. Metabolic alkalosis [4 weeks]

   Change in serum bicarbonate level

2. Urine output [4 weeks]

   Change in 24-hr urine volume

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Hypokalemia

• metabolic alkalosis

• normal blood pressure

• random urine chloride >20 milliequivalent per liter (mEq/L)

• Elevated serum aldosterone and renin levels

Exclusion Criteria:

• Hypertension

• History of emesis

• Prior use of laxatives

• Cystic fibrosis ofpancrease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fateme Ghane Sharbaf	Mashhad		Iran, Islamic Republic of
2	Semnan University of Medical Sciences	Semnan		Iran, Islamic Republic of	011000
3	Banafshe Dormansh	Tehran		Iran, Islamic Republic of
4	Simin Sadeghi	Zahedan		Iran, Islamic Republic of

Sponsors and Collaborators

• Tehran University of Medical Sciences

Investigators

• Study Director: Farahnak Assadi, MD, Rush University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tehran University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT03847571
• Other Study ID Numbers: Acetazolamide (AZ)
• First Posted: Feb 20, 2019
• Last Update Posted: Feb 20, 2019
• Last Verified: Feb 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Tehran University of Medical Sciences: Acetazolamide; Hypokalemic metabolic alkalosis; Bartter syndrome
• Additional relevant MeSH terms: Bartter Syndrome; Alkalosis; Syndrome; Acetazolamide

Study Results

No Results Posted as of Feb 20, 2019