NCT01805362

Brief Summary

Objective: To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough. Duration of the study: Inclusion 2 years, follow-up one year, total 3 years Design: prospective, multicenter, randomized, controlled, open label, two parallel groups. Main selection criteria: Inclusion criteria

  • Chronic kidney disease stage 3 to 4,
  • ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or irbesartan) on awaking for at least three months,
  • History of hypertension or proteinuria \> 0,5 g/24h or g/g créatininurie. Exclusion criteria
  • Office blood pressure ≥ 160/100 mmHg,
  • Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor. Evaluation criteria: Primary: Serum aldosterone levels at one year. Secondary:
  • Serum aldosterone/renin ratio,
  • 24h urine aldosterone,
  • Significant aldosterone breakthrough defined by a \>10% increase of serum aldosterone levels over baseline values,
  • Aldosterone breakthrough defined by an increase of serum aldosterone levels over baseline values,
  • HbA1c,
  • Urinary albumin/creatinine ratio (UACR) on spot morning urine samples,
  • Systolic home blood pressure (SBP),
  • Estimated glomerular filtration rate (eGFR) using the MDRD equation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

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 27, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 28, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2014

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2018

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

February 28, 2013

Last Update Submit

April 10, 2024

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Serum aldosterone levels at one year

    Level change between baseline and one year

Secondary Outcomes (2)

  • Serum aldosterone/renin ratio

    level change between baseline and 12 months

  • Significant aldosterone breakthrough Significant aldosterone breakthrough

    changes between baseline and one year

Study Arms (2)

MORNING

ACTIVE COMPARATOR

patients continue to take their treatments (RAS blockers and diuretics) on awaking

Other: Randomization that determine the time of treatment

EVENING

EXPERIMENTAL

Patients take their treatments(RAS blockers and diurectics)at bedtime

Other: Randomization that determine the time of treatment

Interventions

Randomization that determine the time of treatmentOTHER
Also known as: Randomization determine if the treatment will be taken in the morning or in the evening without changing the treatment
EVENINGMORNING

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic kidney disease stage 3 to 4,
  • ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or irbesartan) on awaking for at least three months,
  • History of hypertension or proteinuria \> 0,5 g/24h or g/g creatininuria,
  • Adult with social security insurance,
  • Informed consent signed.

You may not qualify if:

  • Office blood pressure ≥ 160/100 mmHg,
  • Pathology with life expectancy \< 1 year,
  • Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology, Nice University Hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vincent ESNAULT, MD

    Nice University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2013

First Posted

March 6, 2013

Study Start

February 27, 2013

Primary Completion

April 24, 2014

Study Completion

January 12, 2018

Last Updated

April 11, 2024

Record last verified: 2024-04

Locations

FR(1)