Informations générales (source: ClinicalTrials.gov)
A Phase III, Randomised, Double-Blind Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants With CKD and High Blood Pressure
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
mars 2024
décembre 2027
15 avril 2025
The purpose of this study is to measure the efficacy and safety of
baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN.
This study consists of a screening, a 4-week dapagliflozin run-in period for participants
naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will
receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period
in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin
alone.
Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation.
Thereafter visits will occur approximately every 4 months, until the 24-month visit at
which time baxdrostat/placebo will be discontinued. Participants will continue open-label
dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur
for the primary efficacy endpoint.
In the event of premature discontinuation of blinded study intervention, participants
will continue in the study and receive open-label dapagliflozin monotherapy, unless the
participant meets dapagliflozin specific discontinuation criteria, in which case all
study interventions will be discontinued.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | MONTSENY | 14/02/2025 09:03:13 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Research Site - 07103 - Annonay Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 13385 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 29000 - Quimper - France | Contact (sur clinicalTrials) | ||||
| Research Site - 29200 - Brest Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 30029 - Nimes - France | Contact (sur clinicalTrials) | ||||
| Research Site - 31400 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Research Site - 33076 - Bordeaux cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 37000 - Tours - France | Contact (sur clinicalTrials) | ||||
| Research Site - 43000 - Le Puy-en-Velay - France | Contact (sur clinicalTrials) | ||||
| Research Site - 54511 - Vandoeuvre-Les-Nancy - France | Contact (sur clinicalTrials) | ||||
| Research Site - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 59300 - Valenciennes - France | Contact (sur clinicalTrials) | ||||
| Research Site - 63003 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75015 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75018 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75020 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 76230 - Bois-Guillaume - France | Contact (sur clinicalTrials) | ||||
| Research Site - 80054 - Amiens Cedex 1 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 85925 - La Roche Sur Yon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Research Site - 92104 - Boulogne Billancourt Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 95200 - Sarcelles - France | Contact (sur clinicalTrials) | ||||
| Research Site - 95300 - Pontoise - France | Contact (sur clinicalTrials) | ||||
| Research Site - Montpellier - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Participants of any sex and gender must be ≥ 18 years old, or older, at the time of
signing the informed consent.
2. Participants with CKD and eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
3. Urine albumin creatinine ratio > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565
mg/mmol) at screening
4. Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at
the randomisation visit
5. Stable and maximum tolerated dose of an ACE inhibitor or an ARB (not both) for at
least 4 weeks prior to Screening Visit
6. Central laboratory serum potassium must meet the following criteria at the Screening
Visit, based on screening eGFR:
- for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be ≥
3.0 and ≤ 4.8 mmol/L at the Screening Visit
- for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be ≥
3.0 and ≤ 4.5 mmol/L at the Screening Visit
1. Participants of any sex and gender must be ≥ 18 years old, or older, at the time of
signing the informed consent.
2. Participants with CKD and eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
3. Urine albumin creatinine ratio > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565
mg/mmol) at screening
4. Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at
the randomisation visit
5. Stable and maximum tolerated dose of an ACE inhibitor or an ARB (not both) for at
least 4 weeks prior to Screening Visit
6. Central laboratory serum potassium must meet the following criteria at the Screening
Visit, based on screening eGFR:
- for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be ≥
3.0 and ≤ 4.8 mmol/L at the Screening Visit
- for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be ≥
3.0 and ≤ 4.5 mmol/L at the Screening Visit
1. Systolic blood pressure > 180 mmHg, or DBP > 110 mmHg at screening.
2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at
screening.
3. Serum sodium < 135 mmol/L at the Screening Visit, determined as per central
laboratory.
4. Diabetes mellitus:
(a) T1DM at Screening Visit: (i) For US only: patients with T1DM treated with SGLT2i
for at least 4 months, without DKA during that period, and who have experience with
ketone monitoring are eligible for inclusion.
(ii) For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at
least 4 months, without DKA during the period of dapagliflozin treatment are
eligible for inclusion.
(b) Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol).
5. New York Heart Association functional HF class IV at screening.
6. Stroke, transient ischaemic cerebral attack, valve implantation or valve
replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or
hospitalisation for worsening heart failure within previous 3 months prior to
randomisation.
7. Any dialysis (including for acute kidney injury) within 3 months prior to Screening
Visit.
8. Any acute kidney injury within 3 months prior to the Screening Visit
9. History of organ transplant or bone marrow transplant, or planned organ transplant
within 6 months following randomisation (including kidney transplant).
10. History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2
inhibitor (eg, empagliflozin) or ASI.
11. Any clinical condition requiring systemic immunosuppression therapy other than
stable maintenance therapy for at least 3 months prior to Visit 1.
12. Any use of mineralocorticoid receptor antagonists (such as spironolactone,
eplerenone, or finerenone), potassium-sparing diuretics (such as triamterene or
amiloride), or potassium binders (such as sodium zirconium cyclosilicate, patiromer,
or sodium polystyrene sulfonate) within 4 weeks prior to screening.