NCT01146197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2009

Enrollment Period

2.8 years

First QC Date

June 16, 2010

Last Update Submit

December 9, 2013

Conditions

Gitelman Syndrome

Keywords

HypokalemiaHypomagnesemiaSalt loosing nephropathy

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone

    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)

    2 months

  • To evaluate the effectiveness of eplerenone and amiloride on hypokalemia.

    2 months

  • To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders

    2 months

Study Arms (6)

Amiloride, Indometacin, Eplerenone

EXPERIMENTAL

Amiloride, indometacin(+Omeprazole), Eplerenone

Drug: TREATMENT

Amiloride, Eplerenone, indometacin

EXPERIMENTAL

Amiloride, Eplerenone, indometacin (+Omeprazole)

Drug: TREATMENT

Eplerenone, Amiloride, indometacin

EXPERIMENTAL

Eplerenone, Amiloride, indometacin (+Omeprazole)

Drug: TREATMENT

Eplerenone, Indometacin, Amiloride

EXPERIMENTAL

Eplerenone, Indometacin, Amiloride

Drug: TREATMENT

Indometacin, Eplerenone, Amiloride

EXPERIMENTAL

Indometacin, Eplerenone, Amiloride

Drug: TREATMENT

Indometacin, Amiloride, Eplerenone

EXPERIMENTAL

Indometacin, Amiloride, Eplerenone

Drug: TREATMENT

Interventions

TREATMENTDRUG

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.

Also known as: MODAMINE; Inspra and CHRONOINDOCID
Amiloride, Eplerenone, indometacinAmiloride, Indometacin, EplerenoneEplerenone, Amiloride, indometacinEplerenone, Indometacin, AmilorideIndometacin, Amiloride, EplerenoneIndometacin, Eplerenone, Amiloride

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients 18-60 yrs old, both sex, with genetically proven Gitelman's syndrome, under birth pill control for woman.

You may not qualify if:

  • counter-indication to treatment under study
  • Other diuretic or NAIS treatments than amiloride, spironolactone, or indometacin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Européen Georges Pompidou

Paris, 75015, France

Location

Related Publications (1)

  • 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.

    PMID: 33107592DERIVED

MeSH Terms

Conditions

Gitelman SyndromeHypokalemia

Interventions

TherapeuticsEplerenone

Condition Hierarchy (Ancestors)

Renal Tubular Transport, Inborn ErrorsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Blanchard Anne, MD,PhD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2010

First Posted

June 17, 2010

Study Start

February 1, 2010

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

December 10, 2013

Record last verified: 2009-12

Locations

FR(1)