NCT01805362: IRAB2

RAS Blockade at Bedtime Versus on Awakening for Aldosterone Breakthrough

Completed NA Last updated 11 April 2024

What this trial tests

NA trial testing Randomization that determine the time of treatment in Chronic Kidney Disease in 104 participants. Completed in 12 January 2018.

Timeline

27 February 2013

Primary endpoint
24 April 2014

12 January 2018

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nice
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	104
Start date	27 February 2013
Primary completion	24 April 2014
Estimated completion	12 January 2018
Sites	1 location across France

Drugs / interventions tested

• Randomization that determine the time of treatment

Conditions studied

• Chronic Kidney Disease — all drugs for Chronic Kidney Disease →

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

18 and older, any sex, with Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.