Input of the Use of Indometacin in Gitelman Syndrome as Compared to Potassium Sparing Diuretics (GITAB)
Primary Purpose
Gitelman Syndrome
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
TREATMENT
Sponsored by
About this trial
This is an interventional treatment trial for Gitelman Syndrome focused on measuring Hypokalemia, Hypomagnesemia, Salt loosing nephropathy
Eligibility Criteria
Inclusion Criteria:
- patients 18-60 yrs old, both sex, with genetically proven Gitelman's syndrome, under birth pill control for woman.
Exclusion Criteria:
- counter-indication to treatment under study
- Other diuretic or NAIS treatments than amiloride, spironolactone, or indometacin
Sites / Locations
- Hopital Européen Georges Pompidou
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Amiloride, Indometacin, Eplerenone
Amiloride, Eplerenone, indometacin
Eplerenone, Amiloride, indometacin
Eplerenone, Indometacin, Amiloride
Indometacin, Eplerenone, Amiloride
Indometacin, Amiloride, Eplerenone
Arm Description
Amiloride, indometacin(+Omeprazole), Eplerenone
Amiloride, Eplerenone, indometacin (+Omeprazole)
Eplerenone, Amiloride, indometacin (+Omeprazole)
Eplerenone, Indometacin, Amiloride
Indometacin, Eplerenone, Amiloride
Indometacin, Amiloride, Eplerenone
Outcomes
Primary Outcome Measures
To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone
Secondary Outcome Measures
To evaluate the effectiveness of indomethacin on disorders possibly induced by chronic hypokalemia and /or hypomagnesemia (EKG, lipid disorders related to insulin resistance, glucose/ insulin ratio)
To evaluate the effectiveness of eplerenone and amiloride on hypokalemia.
To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders
To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders other than hypokalemia (hypomagnesemia, hyperaldosteronism), glomerular filtration rate, hypotension, clinical tolerance, and quality of life.
Full Information
NCT ID
NCT01146197
First Posted
June 16, 2010
Last Updated
December 9, 2013
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01146197
Brief Title
Input of the Use of Indometacin in Gitelman Syndrome as Compared to Potassium Sparing Diuretics
Acronym
GITAB
Official Title
Evaluation of Safety and Efficacity of Indometacin and Two Potassium Sparing Diuretics in Adult Patients Affected by Gitelman Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Gitelman syndrome is a rare renal disease where the kidneys are unable to normally retain some salts (sodium, potassium and magnesium). Main consequences of these renal leaks of salts are a tendency toward low blood pressure, hypokalemia and hypomagnesemia both contributing to cardiac and muscles symptoms.
Detailed Description
Patients with received in random order 75mg/day indometacin (Chronoindocid®), 10-20 mg/day amiloride and 50-150 mg /day eplerenone (Inspra ®). The three 6 weeks-periods of treatment will be followed by six weeks washout period. 3-6 weeks before the first period of treatment, a supplementation with potassium and magnesium will be orally given, and maintained at the same dose throughout the study and stoped 6 weeks after the end of the third period of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gitelman Syndrome
Keywords
Hypokalemia, Hypomagnesemia, Salt loosing nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amiloride, Indometacin, Eplerenone
Arm Type
Experimental
Arm Description
Amiloride, indometacin(+Omeprazole), Eplerenone
Arm Title
Amiloride, Eplerenone, indometacin
Arm Type
Experimental
Arm Description
Amiloride, Eplerenone, indometacin (+Omeprazole)
Arm Title
Eplerenone, Amiloride, indometacin
Arm Type
Experimental
Arm Description
Eplerenone, Amiloride, indometacin (+Omeprazole)
Arm Title
Eplerenone, Indometacin, Amiloride
Arm Type
Experimental
Arm Description
Eplerenone, Indometacin, Amiloride
Arm Title
Indometacin, Eplerenone, Amiloride
Arm Type
Experimental
Arm Description
Indometacin, Eplerenone, Amiloride
Arm Title
Indometacin, Amiloride, Eplerenone
Arm Type
Experimental
Arm Description
Indometacin, Amiloride, Eplerenone
Intervention Type
Drug
Intervention Name(s)
TREATMENT
Other Intervention Name(s)
MODAMINE; Inspra and CHRONOINDOCID
Intervention Description
Patients with received in random order 75mg/day indometacin(chronoindocid®), 10-20 mg/day amiloride and 50-150 mg /day eplerenone (Inspra ®). The three 6 weeks-periods of treatment will be followed by six weeks washout period. 3-6 weeks before the first period of treatment, a supplementation with potassium and magnesium will be orally given, and maintained at the same dose throughout the study and stoped 6 weeks after the end of the third period of treatment.
Primary Outcome Measure Information:
Title
To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone
Time Frame
2 months
Secondary Outcome Measure Information:
Title
To evaluate the effectiveness of indomethacin on disorders possibly induced by chronic hypokalemia and /or hypomagnesemia (EKG, lipid disorders related to insulin resistance, glucose/ insulin ratio)
Time Frame
2 months
Title
To evaluate the effectiveness of eplerenone and amiloride on hypokalemia.
Time Frame
2 months
Title
To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders
Description
To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders other than hypokalemia (hypomagnesemia, hyperaldosteronism), glomerular filtration rate, hypotension, clinical tolerance, and quality of life.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients 18-60 yrs old, both sex, with genetically proven Gitelman's syndrome, under birth pill control for woman.
Exclusion Criteria:
counter-indication to treatment under study
Other diuretic or NAIS treatments than amiloride, spironolactone, or indometacin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blanchard Anne, MD,PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33107592
Citation
Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
Results Reference
derived
Learn more about this trial
Input of the Use of Indometacin in Gitelman Syndrome as Compared to Potassium Sparing Diuretics
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