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Compares treatment options for Chronic Kidney Disease(CKD)
Official 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
ClinicalTrials.gov ID: NCT05732727
What this study is testing
What is Antihypertensive algorithm?
Antihypertensive algorithm is an investigational medicine, being studied as a potential treatment for chronic kidney disease(ckd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Chronic kidney disease (CKD) is a major public health issue worldwide. Hypertension is the first risk factor in patients with CKD for mortality, cardiovascular disease and end-stage renal disease.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Clinical signs of hypovolemia
- Symptomatic orthostatic hypotension
- Hyponatremia (\<130 mmol/L)
See the full eligibility 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...
- 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
- 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...
- Clinical signs of hypovolemia
- Symptomatic orthostatic hypotension
- Hyponatremia (\<130 mmol/L)
- Dyskalemia (\ 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
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Bordeaux, France
- Brest, France
- Chalon-sur-Saône, France
- Chartres, France
- Clermont-Ferrand, France
- Colmar, France
- Grenoble, France
- Haguenau, France
- La Roche-sur-Yon, France
- Le Mans, France
- Le Puy-en-Velay, France
- Lille, France
- Limoges, France
- Lorient, France
- Lyon, France
- Marseille, France
- Metz, France
- Mulhouse, France
- Nantes, France
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Bordeaux, France; Brest, France; Chalon-sur-Saône, France; Chartres, France; Clermont-Ferrand, France and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.