A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure

Plain English Summary

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 is a Phase 3 clinical trial sponsored by AstraZeneca studying Chronic Kidney Disease and Hypertension. Tests the effectiveness and safety of Baxdrostat combined with Dapagliflozin in reducing kidney and heart problems in people with chronic kidney disease and high blood pressure. For adults aged 18 and older with chronic kidney disease and high blood pressure, who have been on a stable dose of ACEi or ARB for at least 4 weeks. Participation involves taking Baxdrostat or placebo tablets along with Dapagliflozin tablets, and regular check-ups. Alternative treatments include other medications for high blood pressure and chronic kidney disease. The trial aims to enroll 5000 participants.

Official Summary

International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible participants are adults aged 18 and older with chronic kidney disease and high blood pressure. Excluded are those with uncontrolled diabetes, recent kidney or heart issues, or other serious health conditions. Age: 18 years and older. Health requirements: Stable blood pressure, stable dose of ACEi or ARB, and certain kidney function levels. This trial is studying Chronic Kidney Disease and Hypertension, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures the risk of kidney and heart problems, which means patients could benefit from reduced risk of severe health issues. The specific primary outcome measures are: To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, Heart Failure events(HF), or CV death. (Up to 37 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a critical gap in treatment for chronic kidney disease and high blood pressure, aiming to reduce serious complications like kidney failure and heart events. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Chronic Kidney Disease and Hypertension, where improved treatment options are needed.

Investor Insight

The large market size and competitive landscape suggest a high probability of approval, making this a promising investment opportunity. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 5000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if you have chronic kidney disease and high blood pressure, and if you meet the age and health criteria. Participation involves taking daily tablets and attending regular check-ups. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 5,000 participants

Interventions

• DRUG: Baxdrostat/dapagliflozin — baxdrostat tablet dapagliflozin tablet
• DRUG: Placebo/dapagliflozin — dapagliflozin tablet placebo tablet

Primary Outcomes

• To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, Heart Failure events(HF), or CV death. (Up to 37 months)

Secondary Outcomes

• To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure or CV death. (Up to 37 months)
• To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of kidney failure (Up to 37 months)
• To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of MACE (Major Adverse Cardiac Events). (Up to 37 months)
• To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of CV (cardiovascular) death. (Up to 37 months)
• To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of all-cause death. (Up to 37 months)

Full Eligibility Criteria

Inclusion Criteria:

1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
2. Participants with (a) or (b):

   a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND:
   * 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
   * UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only).

     (b) eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND:
   * 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)
3. \[obsolete\]
4. 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.
5. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.
6. Participants with:

   1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values)
   2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR \< 45 mL/min/1.73 m2 (local or central laboratory values)

Exclusion Criteria:

1. Systolic blood pressure \> 180 mmHg, or diastolic BP \> 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 (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).

4\. Participants with T1DM will be excluded, except:

1. 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.
2. 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.

   5 Uncontrolled T2DM with HbA1c \> 10.5% (\> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).

   6 New York Heart Association functional HF class IV at screening.

   7 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.

   8 Documented history of adrenal insufficiency.

   9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.

   10 Any acute kidney injury within 3 months prior to the Screening Visit.

   11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).

   12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).

Trial Locations

• Research Site, Fairhope, Alabama, United States
• Research Site, Surprise, Arizona, United States
• Research Site, Tucson, Arizona, United States
• Research Site, Beverly Hills, California, United States
• Research Site, Canoga Park, California, United States
• Research Site, Concord, California, United States
• Research Site, Fremont, California, United States
• Research Site, Fullerton, California, United States
• Research Site, Inglewood, California, United States
• Research Site, Los Alamitos, California, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Chronic kidney disease, hypertension, cardiovascular disease, diabetes, heart failure

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