NCT02297048

Brief Summary

Progesterone is needed to permit adaptation of the kidney to limit potassium loss in the urines. The investigators wonder whether progesterone or other adrenal hormon play the same role. The investigators will investigate surrenal hormone production in healthy subjects under a 7-day potassium depleted diet and in patients chronically hypokalaemic due to a renal loss of potassium.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2014

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

July 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

1.2 years

First QC Date

October 29, 2014

Last Update Submit

September 30, 2015

Conditions

Gitelman SyndromePotassium Depletion

Keywords

Potassium intakeProgesteronesteroidogenesisRU486Synachtene test

Outcome Measures

Primary Outcomes (1)

  • Effect of potassium depletion on plasma progesterone (Change from Baseline of progesterone)

    Healthy subjects : Change from Baseline of progesterone in response to synacthen at day 8 in subject treated by placebo. Patients with Gitelman syndrome: Change from Baseline of progesterone in response to synacthen

    Day 1 and Day 8 of placebo period of treatment (healthy subjects) or once (Gitelman patients)

Secondary Outcomes (3)

  • effect of RU 486 on renal adaptation to potassium depletion (Plasma potassium and kaliuresis will be monitored )

    Day 1 and day 8 of each period of treatment

  • Effect of potassium depletion on pulse pressure velocity (Pulse wave velocity and central blood pressure)

    At Day 1 and Day 8 of each period of treatment

  • Effect of potassium depletion on plasma progesterone under RU486 (Change from Baseline of progesterone)

    Day 1 and Day 8 of placebo period of treatment (healthy subjects) or once (Gitelman patients)

Study Arms (2)

RU 486 (mifepristone)

EXPERIMENTAL

Subjects will receive 400 mg once a day of RU486

Dietary Supplement: Potassium depletion

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo once a day

Dietary Supplement: Potassium depletion

Interventions

Potassium depletionDIETARY_SUPPLEMENT

Healthy subjects will be submitted twice at 15-30 day interval, to a low potassium diet (20mmol/day)

PlaceboRU 486 (mifepristone)

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caucasian male subject
  • yrs-old
  • BMI between 18 and 30 Kg/m2
  • Normal biological pattern (sodium, potassium, eGFR \>60mL/min/1.73 m2, SGOT and SGPT \< 2.5 normal value)
  • Non smoker subjects or less than 5 cigarettes a day
  • No drug abuse
  • No active viral B or C hepatitis, no positive HIV serology
  • No treatment except paracetamol
  • Normal EKG
  • Inform consent given
  • Affiliation to French Medicare assurance
  • Years old subjects
  • genetically proven Gitelman syndrome
  • Normal EKG
  • Inform consent given
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European George Pompidou Hospital

Paris, 75015, France

Location

Related Publications (2)

  • Elabida B, Edwards A, Salhi A, Azroyan A, Fodstad H, Meneton P, Doucet A, Bloch-Faure M, Crambert G. Chronic potassium depletion increases adrenal progesterone production that is necessary for efficient renal retention of potassium. Kidney Int. 2011 Aug;80(3):256-62. doi: 10.1038/ki.2011.15. Epub 2011 Feb 16.

    PMID: 21326170BACKGROUND

  • Blanchard A, Brailly Tabard S, Lamaziere A, Bergerot D, Zhygalina V, Lorthioir A, Jacques A, Hourton D, Azizi M, Crambert G. Adrenal adaptation in potassium-depleted men: role of progesterone? Nephrol Dial Transplant. 2020 Nov 1;35(11):1901-1908. doi: 10.1093/ndt/gfz135.

    PMID: 31369102DERIVED

MeSH Terms

Conditions

Gitelman SyndromeHypokalemia

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

Study Officials

  • Anne Blanchard, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2014

First Posted

November 21, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations

FR(1)