Gitelman SyndromePhase 1/2GITABNCT01146197
Input of the Use of Indometacin in Gitelman Syndrome as Compared to Potassium Sparing Diuretics
A Phase 1/2 study testing TREATMENT in people with Gitelman Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gitelman Syndrome
- What is being tested?
- TREATMENT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Jan 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients 18-60 yrs old, both sex, with genetically proven Gitelman's syndrome, under birth pill control for woman.
Who cannot join
- counter-indication to treatment under study
- Other diuretic or NAIS treatments than amiloride, spironolactone, or indometacin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety and Efficacity of Indometacin and Two Potassium Sparing Diuretics in Adult Patients Affected by Gitelman Syndrome
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.
Read the 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.
- Conditions
- Gitelman Syndrome
- Being tested
- TREATMENT
- Keywords
- Hypokalemia, Hypomagnesemia, Salt loosing nephropathy
- Medical subject headings
- Gitelman Syndrome, Hypokalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREATMENTDrug
Also called MODAMINE; Inspra and CHRONOINDOCID
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.
| Study group | Role | What they receive |
|---|---|---|
| Amiloride, Indometacin, Eplerenone | Experimental | Amiloride, indometacin(+Omeprazole), Eplerenone Receives: Drug: TREATMENT |
| Amiloride, Eplerenone, indometacin | Experimental | Amiloride, Eplerenone, indometacin (+Omeprazole) Receives: Drug: TREATMENT |
| Eplerenone, Amiloride, indometacin | Experimental | Eplerenone, Amiloride, indometacin (+Omeprazole) Receives: Drug: TREATMENT |
| Eplerenone, Indometacin, Amiloride | Experimental | Eplerenone, Indometacin, Amiloride Receives: Drug: TREATMENT |
| Indometacin, Eplerenone, Amiloride | Experimental | Indometacin, Eplerenone, Amiloride Receives: Drug: TREATMENT |
| Indometacin, Amiloride, Eplerenone | Experimental | Indometacin, Amiloride, Eplerenone Receives: Drug: TREATMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone
Measured: 2 months
Secondary outcomes (3)
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)
Measured: 2 months
To evaluate the effectiveness of eplerenone and amiloride on hypokalemia.
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gitelman SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blanchard Anne, MD,PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146197
- Sponsor's protocol ID
- P071242
- Acronym
- GITAB
- Status last verified
- Dec 2009
- First submitted
- 16 Jun 2010
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33107592
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacity of Indometacin and Two Potassium Sparing Diuretics in Adult Patients Affected by Gitelman Syndrome
- ClinicalTrials.gov ID
- NCT01146197
- Acronym / sponsor ID
- GITAB / P071242
- Conditions
- Gitelman Syndrome
- Keywords
- Hypokalemia, Hypomagnesemia, Salt loosing nephropathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Amiloride, Indometacin, Eplerenone | Experimental | Drug: TREATMENTAmiloride, indometacin(+Omeprazole), Eplerenone |
| Amiloride, Eplerenone, indometacin | Experimental | Drug: TREATMENTAmiloride, Eplerenone, indometacin (+Omeprazole) |
| Eplerenone, Amiloride, indometacin | Experimental | Drug: TREATMENTEplerenone, Amiloride, indometacin (+Omeprazole) |
| Eplerenone, Indometacin, Amiloride | Experimental | Drug: TREATMENTEplerenone, Indometacin, Amiloride |
| Indometacin, Eplerenone, Amiloride | Experimental | Drug: TREATMENTIndometacin, Eplerenone, Amiloride |
| Indometacin, Amiloride, Eplerenone | Experimental | Drug: TREATMENTIndometacin, Amiloride, Eplerenone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients 18-60 yrs old, both sex, with genetically proven Gitelman's syndrome, under birth pill control for woman.
Key exclusion criteria (2 listed)
- counter-indication to treatment under study
- Other diuretic or NAIS treatments than amiloride, spironolactone, or indometacin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TREATMENTAlso: MODAMINE; Inspra and CHRONOINDOCIDPatients 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. | Drug | Amiloride, Eplerenone, indometacin, Amiloride, Indometacin, Eplerenone, Eplerenone, Amiloride, indometacin, Eplerenone, Indometacin, Amiloride, Indometacin, Amiloride, Eplerenone, Indometacin, Eplerenone, Amiloride |
Primary outcome
To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone
Time frame: 2 months
3 secondary outcomes
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
To evaluate the effectiveness of eplerenone and amiloride on hypokalemia.
Time frame: 2 months
To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
- Derived from this study: PubMed 33107592Chung 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.
Related trials for Gitelman Syndrome
RecruitingObservational study
The Osteoarticular Manifestations in Patients With Gitelman Syndrome
Gitelman Syndrome, CPPD - Calcium Pyrophosphate Deposition Disease
RecruitingObservational study
National Registry of Rare Kidney Diseases
Adenine Phosphoribosyltransferase Deficiency, AH Amyloidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blanchard Anne, MD,PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TREATMENT in people with Gitelman Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01146197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2013.