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Acetazolamide (AZ) for Management of Alkalosis in Bartter Syndrome (AZ)

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ClinicalTrials.gov Identifier: NCT03847571
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

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
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.


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Study Type : Observational
Estimated 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 : January 10, 2019
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort 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)




Primary Outcome Measures :
  1. Metabolic alkalosis [ Time Frame: 4 weeks ]
    Change in serum bicarbonate level

  2. Urine output [ Time Frame: 4 weeks ]
    Change in 24-hr urine volume



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children between 1 and 10 years of age with failure to thrive, polyuria and unexplained hypokalemic metabolic alkalosis will be recruited for this trial.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847571


Contacts
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Contact: Farahnak Assadi, MD 3125600477 fassadi@rush.edu
Contact: Mojgan Mazaheri, MD 00-98 9123069789 mojganmazaheri@yahoo.com

Locations
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Iran, Islamic Republic of
Fateme Ghane Sharbaf Recruiting
Mashhad, Iran, Islamic Republic of
Contact: Fateme Ghane Sharbaf, MD    00 98 9153112139    ghanesharbaf@gmail.com   
Contact: Farahnak Assadi    3125600477    fassadi@rush.edu   
Semnan University of Medical Sciences Recruiting
Semnan, Iran, Islamic Republic of, 011000
Contact: Mojgan Mazaheri, MD    9123069789    mojganmazaheri@yahoo.com   
Contact: Farahnak Assadi, MD    3125600477    fassadi@rush.edu   
Banafshe Dormansh Not yet recruiting
Tehran, Iran, Islamic Republic of
Contact: Banafshe Dormanesh, MD    00 98 9123886725    dr.dormansh@yahoo.com   
Contact: Farahnak Assadi, MD    3125600477    Farahnak_Assadi@rush.edu   
Simin Sadeghi Recruiting
Zahedan, Iran, Islamic Republic of
Contact: Simin Sadeghi, MD    00 98 54533295573    sisadegh@yahoo.com   
Contact: Farahnak Assadi, MD    3125600477    fassadi@rush.edu   
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Study Director: Farahnak Assadi, MD Rush University Medical Center

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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03847571     History of Changes
Other Study ID Numbers: Acetazolamide (AZ)
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019

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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:
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Bartter Syndrome
Alkalosis
Syndrome
Disease
Pathologic Processes
Acid-Base Imbalance
Metabolic Diseases
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs