Actively Recruiting
Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension in Patients With Moderate to Severe Chronic Kidney Disease: an Open Label, Cluster Randomized Controlled Phase 3 Trial
Led by University Hospital, Tours · Updated on 2025-12-01
720
Participants Needed
40
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic kidney disease (CKD) is a serious global health issue often complicated by hypertension, which increases risks for death, heart problems, and kidney failure. Lowering blood pressure is known to reduce these risks, but the best drug strategies for controlling blood pressure in CKD patients remain unclear. Researchers believe that patients with CKD and uncontrolled hypertension may have excess fluid, and that using diuretics as a second treatment after standard drugs may help improve outcomes. This trial compares two approaches for managing uncontrolled hypertension in patients with moderate to severe CKD. One group will follow a specific treatment plan using diuretics to adjust blood pressure medication, while the other group will receive usual care based on their clinician's standard methods. The study is an open-label, cluster randomized controlled Phase 3 trial evaluating these strategies over time. Participants will be monitored for up to 36 months to assess key health outcomes including progression to end-stage kidney disease, decline in kidney function, cardiovascular events, and overall mortality. The trial will also track blood pressure changes, medication use, protein levels in urine, and quality of life. Regular assessments will help researchers understand the impact of diuretic-based treatment compared to usual care in this patient population.
CONDITIONS
Brief Title
Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older with a clinical frailty score 65 for those over 80 years
- Moderate to advanced chronic kidney disease with eGFR between 15 and 44.9 mL/min/1.73m²
- Arterial hypertension treated with at least one blood pressure lowering drug (ACE inhibitor or ARB) at maximum tolerated dose stable for at least one month
- Uncontrolled office blood pressure confirmed by home or ambulatory blood pressure monitoring
- Participant covered by or entitled to social security
- Written informed consent obtained
You will not qualify if you...
- Under any legal protection measures
- Pregnant or breastfeeding women
- Women of childbearing potential without highly effective contraception
- Clinical signs of low blood volume (hypovolemia)
- Symptomatic orthostatic hypotension
- Low sodium levels (hyponatremia below 130 mmol/L)
- Abnormal potassium levels (below 3.5 or above 5.5 mmol/L)
- Major cardiovascular events in last three months (heart attack, heart failure hospitalization, stroke)
- Current cancer requiring chemotherapy
- Solid organ transplant recipients
- Use of two or more diuretics
- Use of mineralocorticoid receptor antagonists
- Polycystic kidney disease treated with Tolvaptan
- Contraindication to diuretics used in the study
- Severe heart failure (NYHA class III or IV)
- Severe liver cirrhosis (Child-Pugh B or C)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants receive intensified blood pressure lowering therapy either through an antihypertensive algorithm based on diuretics or standard care management to control hypertension.
Regular visits as determined by clinicians for adjustment and monitoring
Trial Site Locations
Total: 40 locations
1
Department of Nephrology, University Hospital of Angers
Angers, France, 49933
Actively Recruiting
2
Department of Nephrology, University Hospital of Bordeaux
Bordeaux, France, 33000
Actively Recruiting
3
AUB Santé foundation, Brest
Brest, France, 29200
Actively Recruiting
4
Department of Nephrology, University Hospital of Brest
Brest, France, 29200
Actively Recruiting
5
Department of Nephrology, Hospital of Chalon-sur-Saône
Chalon-sur-Saône, France
Actively Recruiting
6
Department of Nephrology, Hospital of Chartres
Chartres, France, 28630
Actively Recruiting
7
Department of Nephrology, University Hospital of Clermont-Ferrand
Clermont-Ferrand, France, 63001
Actively Recruiting
8
Department of Nephrology, Hospital of Colmar
Colmar, France, 68024
Actively Recruiting
9
Department of Nephrology, University Hospital of Grenoble
Grenoble, France, 38043
Actively Recruiting
10
Department of Nephrology, Hospital of Haguenau
Haguenau, France, 67500
Actively Recruiting
11
Department of Nephrology, Departemental Hospital of Vendée
La Roche-sur-Yon, France, 85925
Actively Recruiting
12
ECHO Santé Association, Le Mans
Le Mans, France, 72100
Actively Recruiting
13
Department of Nephrology, Hospital of Le Puy en Velay
Le Puy-en-Velay, France, 43012
Actively Recruiting
14
Department of Nephrology, University Hospital of Lille
Lille, France, 59000
Actively Recruiting
15
Department of Nephrology, University Hospital of Limoges
Limoges, France, 87042
Actively Recruiting
16
AUB Santé foundation, Lorient
Lorient, France, 56100
Actively Recruiting
17
Department of Nephrology, University Hospital of Lyon
Lyon, France, 69003
Actively Recruiting
18
Department of Nephrology, University Hospital of Marseille
Marseille, France, 13005
Actively Recruiting
19
Department of Nephrology, Regional Hospital of Metz
Metz, France, 57085
Actively Recruiting
20
Department of Nephrology, Régional Hospital of Mulhouse
Mulhouse, France, 68100
Actively Recruiting
21
Department of Nephrology, University Hospital of Nantes
Nantes, France, 44093
Actively Recruiting
22
ECHO Santé Association, Nantes
Nantes, France, 44402
Actively Recruiting
23
Department of Nephrology, University Hospital of Nîmes
Nîmes, France, 30029
Actively Recruiting
24
Department of Nephrology, Hospital of Orléans
Orléans, France, 45067
Actively Recruiting
25
Department of Nephrology, European Hospital Georges Pompidou, AP-HP
Paris, France, 75015
Active, Not Recruiting
26
Department of Nephrology, Necker Hospital, AP-HP
Paris, France, 75015
Actively Recruiting
27
Department of Nephrology, Bichat Hospital, AP-HP
Paris, France, 75018
Actively Recruiting
28
Department of Nephrology, Tenon Hospital, AP-HP
Paris, France, 75020
Active, Not Recruiting
29
Department of Nephrology, Hospital of Perpignan
Perpignan, France, 66046
Actively Recruiting
30
Department of Nephrology, University Hospital of Reims
Reims, France, 51092
Actively Recruiting
31
Department of Nephrology, University Hospital of Rennes
Rennes, France, 35033
Actively Recruiting
32
Department of Nephrology, Hospital of Roubaix
Roubaix, France, 59100
Actively Recruiting
33
Department of Nephrology, University Hospital of Rouen
Rouen, France, 76230
Actively Recruiting
34
Department of Nephrology, University Hospital of Saint Etienne
Saint-Etienne, France, 42270
Actively Recruiting
35
ECHO Santé Association, Saint Herblain
Saint-Herblain, France, 44819
Active, Not Recruiting
36
Department of Nephrology, Hospital of Saint Malo
St-Malo, France, 35400
Actively Recruiting
37
Department of Nephrology, Hospital of Strasbourg
Strasbourg, France, 67000
Actively Recruiting
38
Department of Nephrology, University Hospital of Tours
Tours, France, 37044
Actively Recruiting
39
Department of Nephrology, Hospital of Valenciennes
Valenciennes, France, 59322
Actively Recruiting
40
Department of Nephrology, University Hospital of Nancy
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
Research Team
B
Bénédicte Sautenet, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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