Improving blood pressure management in patients with chronic kidney disease
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, a Cluster Randomized Controlled, Phase 3 Trial
This study tests if a stronger approach to lowering blood pressure using diuretics can help people with chronic kidney disease and high blood pressure feel better and stay healthier.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 720 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Tours Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 40 sites (Angers and 39 other locations) |
| Trial ID | NCT05732727 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intensifying blood pressure-lowering treatments, specifically using diuretics, compared to standard management in patients with moderate to severe chronic kidney disease (CKD) who have uncontrolled hypertension. The study aims to determine if a tailored antihypertensive algorithm can lead to better blood pressure control and improved health outcomes in this high-risk population. Participants will be monitored for their blood pressure levels and overall kidney function throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with moderate to severe chronic kidney disease and uncontrolled hypertension despite current treatment.
Not a fit: Patients with severe kidney disease (eGFR <15 mL/min/1.73m²) or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better blood pressure control and reduced complications for patients with chronic kidney disease.
How similar studies have performed: Other studies have shown promising results with similar approaches to managing hypertension in patients with chronic kidney disease, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female \>=18 years with a clinical frailty score ≤5 for patient aged over 80 * Advanced or moderate chronic kidney disease (eGFR 15 to 44.9 mL/min/1.73m² using CKD-EPI formula) * Arterial hypertension treated with at least one blood pressure lowering drug therapy among blockers of the renin-angiotensin system (ACEi or ARB), at the maximal posology tolerated by the patients stable since at least one month. Other blood pressure lowering drug therapies are tolerated in combination with or in the event of intolerance to ACE inhibitors or ARBs. * Uncontrolled office BP * Uncontrolled office BP (\>140 and/or 90 mmHg) confirmed by home blood pressure monitoring (\>135 and/or 85 mmHg) or Day-time Ambulatory Blood Pressure Monitoring * Participant covered by or entitled to social security * Written informed consent obtained from the participant Exclusion Criteria: * Patient following any measures of legal presentation * Pregnant or breastfeeding woman * woman of childbearing without a highly effective contraceptive measure (combined or progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device or intrauterine hormone-releasing system) * Clinical signs of hypovolemia * Symptomatic orthostatic hypotension * Hyponatremia (\<130 mmol/L) * Dyskalemia (\<3,5 mmol/L or \>5,5 mmol/L) * Major adverse cardiovascular event during the last three months: myocardial infarction, heart failure hospitalization, stroke * Current medical history of cancer requiring chemotherapy * Solid organ transplantation * Two or more diuretic agents (loop diuretic, thiazides and thiazide-like diuretics) * Mineralocorticoid receptor antagonists * Autosomal dominant polycystic kidney disease treated with Tolvaptan * Contraindication to diuretics involved in the algorithm * Severe heart failure (NYHA III\_IV) * Cirrhosis Child B-C
Where this trial is running
Angers and 39 other locations
- Department of Nephrology, University Hospital of Angers — Angers, France (Recruiting)
- Department of Nephrology, University Hospital of Bordeaux — Bordeaux, France (Recruiting)
- AUB Santé foundation, Brest — Brest, France (Recruiting)
- Department of Nephrology, University Hospital of Brest — Brest, France (Recruiting)
- Department of Nephrology, Hospital of Chalon-sur-Saône — Chalon-sur-Saône, France (Recruiting)
- Department of Nephrology, Hospital of Chartres — Chartres, France (Recruiting)
- Department of Nephrology, University Hospital of Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- Department of Nephrology, Hospital of Colmar — Colmar, France (Recruiting)
- Department of Nephrology, University Hospital of Grenoble — Grenoble, France (Recruiting)
- Department of Nephrology, Hospital of Haguenau — Haguenau, France (Recruiting)
- Department of Nephrology, Departemental Hospital of Vendée — La Roche-sur-Yon, France (Recruiting)
- ECHO Santé Association, Le Mans — Le Mans, France (Recruiting)
- Department of Nephrology, Hospital of Le Puy en Velay — Le Puy-en-Velay, France (Recruiting)
- Department of Nephrology, University Hospital of Lille — Lille, France (Recruiting)
- Department of Nephrology, University Hospital of Limoges — Limoges, France (Recruiting)
- AUB Santé foundation, Lorient — Lorient, France (Recruiting)
- Department of Nephrology, University Hospital of Lyon — Lyon, France (Recruiting)
- Department of Nephrology, University Hospital of Marseille — Marseille, France (Recruiting)
- Department of Nephrology, Regional Hospital of Metz — Metz, France (Recruiting)
- Department of Nephrology, Régional Hospital of Mulhouse — Mulhouse, France (Recruiting)
- Department of Nephrology, University Hospital of Nantes — Nantes, France (Recruiting)
- ECHO Santé Association, Nantes — Nantes, France (Recruiting)
- Department of Nephrology, University Hospital of Nîmes — Nîmes, France (Recruiting)
- Department of Nephrology, Hospital of Orléans — Orléans, France (Recruiting)
- Department of Nephrology, European Hospital Georges Pompidou, AP-HP — Paris, France (Active_not_recruiting)
- Department of Nephrology, Necker Hospital, AP-HP — Paris, France (Recruiting)
- Department of Nephrology, Bichat Hospital, AP-HP — Paris, France (Recruiting)
- Department of Nephrology, Tenon Hospital, AP-HP — Paris, France (Active_not_recruiting)
- Department of Nephrology, Hospital of Perpignan — Perpignan, France (Recruiting)
- Department of Nephrology, University Hospital of Reims — Reims, France (Recruiting)
- Department of Nephrology, University Hospital of Rennes — Rennes, France (Recruiting)
- Department of Nephrology, Hospital of Roubaix — Roubaix, France (Recruiting)
- Department of Nephrology, University Hospital of Rouen — Rouen, France (Recruiting)
- Department of Nephrology, University Hospital of Saint Etienne — Saint-Etienne, France (Recruiting)
- ECHO Santé Association, Saint Herblain — Saint-Herblain, France (Active_not_recruiting)
- Department of Nephrology, Hospital of Saint Malo — St-Malo, France (Recruiting)
- Department of Nephrology, Hospital of Strasbourg — Strasbourg, France (Recruiting)
- Department of Nephrology, University Hospital of Tours — Tours, France (Recruiting)
- Department of Nephrology, Hospital of Valenciennes — Valenciennes, France (Recruiting)
- Department of Nephrology, University Hospital of Nancy — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Principal investigator: Bénédicte Sautenet, MD — University Hospital, Tours
- Study coordinator: Bénédicte Sautenet, MD
- Email: benedicte.sautenet@gmail.com
- Phone: 02.34.37.96.86
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.