Dapagliflozin + Baxdrostat for Chronic Kidney Disease
(BaxDuo-Baltic Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of medications, baxdrostat and dapagliflozin, to determine if they can reduce protein in urine (albuminuria) and improve safety for people with chronic kidney disease and high blood pressure. Participants will receive either the baxdrostat/dapagliflozin combination or baxdrostat with a placebo. This trial may suit those managing chronic kidney disease and high blood pressure while on a stable dose of certain blood pressure medications. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial requires that you have been on a stable dose of either an ACE inhibitor or an ARB for at least 4 weeks before screening. You must also avoid certain medications like mineralocorticoid receptor antagonists and potassium-sparing diuretics for 4 weeks before screening.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that baxdrostat, when combined with dapagliflozin, is generally safe and well-tolerated. Studies examining this combination for safety have not identified any major concerns. One study found that baxdrostat significantly lowered blood pressure in patients with chronic kidney disease, which is promising. Although no major side effects have been reported, it's important to note that the treatment has undergone human testing before, so any serious issues would likely have been discovered. Always consult a healthcare professional for personalized advice.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of dapagliflozin and baxdrostat for chronic kidney disease because it offers a fresh approach compared to standard treatments like ACE inhibitors or ARBs. Unlike these traditional therapies, dapagliflozin is a type of SGLT2 inhibitor that helps kidneys remove excess glucose and sodium, which can reduce kidney stress. Baxdrostat, on the other hand, inhibits aldosterone synthesis, potentially providing added kidney protection by controlling blood pressure and reducing inflammation. This dual-action approach targets multiple pathways, which could enhance kidney function and slow disease progression more effectively than current options.
What evidence suggests that this trial's treatments could be effective for chronic kidney disease?
Research shows that using baxdrostat with dapagliflozin may benefit people with chronic kidney disease and high blood pressure. In this trial, one group of participants will receive the combination of baxdrostat and dapagliflozin, while another group will receive baxdrostat with a placebo instead of dapagliflozin. Studies have found that baxdrostat can significantly lower systolic blood pressure by an average of 8.1 mmHg compared to a placebo. Dapagliflozin is already known to help protect the kidneys and control blood sugar levels. Together, these treatments aim to reduce protein in the urine, a sign of kidney damage, and improve kidney function. This combination is being tested because both treatments have shown potential benefits in earlier studies.12345
Are You a Good Fit for This Trial?
Adults with chronic kidney disease and high blood pressure, having a certain level of kidney function (eGFR ≥ 30 and < 90 mL/min/1.73 m2) and albuminuria can join. They must have stable hypertension, be on specific blood pressure meds for at least 4 weeks, and not have severe liver issues or recent dialysis. Uncontrolled type 2 diabetes patients or those with very high potassium levels are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Pre-screening
Optional pre-screening period to assess parameters such as eGFR, UACR, potassium, sodium, and BP
Screening
Participants are screened for eligibility to participate in the trial
Washout
Participants on SGLT2i treatment undergo a washout period before randomization
Treatment
Participants receive either baxdrostat/dapagliflozin or baxdrostat/placebo to evaluate the effect on albuminuria
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Baxdrostat
- Dapagliflozin
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology