A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagl… (NCT06268873) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.
United States2,554 participantsStarted 2024-03-29
Plain-language summary
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 untreated with SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin; and approximately 12-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 12-weeks (approximately), where reassessment of eGFR 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants of any sex and gender must be ≥ 18 years old, or older, at the time of signing the informed consent.
✓. Participants with CKD and eGFR ≥ 30 and \< 90 mL/min/1.73 m2 at screening
✓. Urine albumin creatinine ratio \> 200 mg/g (22.6 mg/mmol) and \< 5000 mg/g (565 mg/mmol) at screening
✓. Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit
✓. Stable and maximum tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening Visit
✓. Central laboratory serum potassium must meet the following criteria at the Screening Visit, based on screening eGFR:
Exclusion criteria
✕. Systolic blood pressure \> 180 mmHg, or DBP \> 110 mmHg at screening.
✕. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
✕. Serum sodium \< 135 mmol/L at the Screening Visit, determined as per central laboratory.
What they're measuring
1
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time.