Chronic Kidney Disease and Hypertension study: Baxdrostat/dapagliflozin
Official title A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
ClinicalTrials.gov ID: NCT06742723
What this study is testing
What is Baxdrostat/dapagliflozin?
Investigational oral tablets being studied as a potential treatment for chronic kidney disease and high blood pressure. Baxdrostat is designed to block mineralocorticoid receptors, and dapagliflozin is designed to inhibit SGLT2 to reduce glucose reabsorption in the kidneys.
Also referred to as Baxdrostat CIN-107, dapagliflozin.
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
- This study is testing whether adding Baxdrostat to dapagliflozin improves kidney outcomes and reduces heart deaths in people with chronic kidney disease and high blood pressure.
- Who it's for
- You may be able to join if you have chronic kidney disease and high blood pressure.
- What's involved
- You will take a medicine called Baxdrostat together with dapagliflozin. You will visit the clinic for check‑ins and give blood or urine samples. You will not know if you get the real drug or a pretend one.
- Time commitment
- The study lasts about 2 years, with regular visits every few months to monitor your health.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
- UACR ≥ 30 mg/g (3.39 mg/mmol) and \< 500 mg/g (56.5 mg/mmol) (central laboratory value only), or
- UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or
- UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or
- UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only)
You likely can't join if
- Systolic blood pressure \> 180 mmHg, or diastolic BP \> 110 mmHg at screening.
- Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
- 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...
- For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment...
See the full eligibility criteria
- Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
- UACR ≥ 30 mg/g (3.39 mg/mmol) and \< 500 mg/g (56.5 mg/mmol) (central laboratory value only), or
- UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or
- UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or
- UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only)
- [obsolete]
- Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.
- Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.
- Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values)
- Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR \< 45 mL/min/1.73 m2 (local or central laboratory values)
- Systolic blood pressure \> 180 mmHg, or diastolic BP \> 110 mmHg at screening.
- Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Fairhope, Alabama, United States
- Sun City, Arizona, United States
- Tucson, Arizona, United States
- Beverly Hills, California, United States
- Concord, California, United States
- Fremont, California, United States
- Fullerton, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Stanford, California, United States
- Tarzana, California, United States
- Arvada, Colorado, United States
- New Britain, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Boca Raton, Florida, United States
- Boynton Beach, Florida, United States
- Edgewater, Florida, United States
- Fort Lauderdale, Florida, United States
- Hollywood, Florida, United States
- Jacksonville Beach, Florida, United States
+ 522 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, but 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?
This study is enrolling now at Fairhope, Alabama, United States; Sun City, Arizona, United States; Tucson, Arizona, United States; Beverly Hills, California, United States; Concord, California, United States; Fremont, California, United States and 536 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.