No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
2,800 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for adults with chronic kidney disease stages 3b and 4. Participants will take a daily combination of two medications to see how well they work together compared to taking just one of them.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesPolycystic kidney disease
You may be able to join if
I am 18 years old or older
I have been diagnosed with chronic kidney disease
I have stable blood potassium levels
I have been on a maximum tolerated dose of ACE inhibitors or ARBs
You may not be able to join if
I have needed dialysis in the past 3 months or will likely need it in the next 3 months
I have very high protein levels in my urine
I have high blood pressure that is too high or too low
I have diabetes with high HbA1c levels
I have had major heart surgery or serious heart issues in the last 12 weeks
I have severe liver problems
I have adrenal insufficiency
I have been hospitalized for heart failure in the last 4 weeks
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to evaluate the efficacy, safety and tolerability of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to \< 45 mL/min/1.73 m2) administered orally once daily in addition to SoC.
This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently …
The purpose of this study is to evaluate the efficacy, safety and tolerability of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to \< 45 mL/min/1.73 m2) administered orally once daily in addition to SoC.
This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from interventional trials.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years
* Diagnosis of CKD and at least one of the following:
1. eGFR ≥ 15 to \< 45 mL/min/1.73 m2 AND: UACR ≥ 30 mg/g (central laboratory) or UACR ≥ 100 mg/g (local laboratory ) or UPCR ≥ 200 mg/g (local laboratory).
2. eGFR ≥ 15 to \< 30 mL/min/1.73 m2 and UACR \…
Inclusion Criteria:
* Age ≥ 18 years
* Diagnosis of CKD and at least one of the following:
1. eGFR ≥ 15 to \< 45 mL/min/1.73 m2 AND: UACR ≥ 30 mg/g (central laboratory) or UACR ≥ 100 mg/g (local laboratory ) or UPCR ≥ 200 mg/g (local laboratory).
2. eGFR ≥ 15 to \< 30 mL/min/1.73 m2 and UACR \< 30 mg/g (local or central laboratory UACR value).
* Serum/plasma K+ ≤ 5.0 mmol/L
* Maximum tolerated dose of an ACEi or an ARB, unless contraindicated or not tolerated. The dose should be stable for at least 4 weeks before screening.
Exclusion Criteria:
* Recent (within 90 days prior to screening) or ongoing dialysis, or likely to require dialysis within 3 months following randomisation
* UACR ≥ 5000 mg/g or UPCR ≥ 7000 mg/g at screening.
* SBP \> 180 mmHg or DBP \> 110 mmHg at screening.
* SBP \< 90 mmHg at screening.
* HbA1c \> 9% at screening
* T1DM, except:
1. For US only: patients with T1DM treated with SGLT2i for at least 4 months prior to screening, without DKA during that period, and who have experience with ketone monitoring are eligible.
2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months prior to Screening, without DKA during the period of dapagliflozin treatment are eligible for inclusion.
* Autosomal dominant polycystic kidney disease.
* Major cardiac or valvular surgery, acute coronary syndrome (myocardial infarction or unstable angina), stroke, transient ischaemic attack within 12 weeks prior to screening.
* Severe hepatic impairment (Child-Pugh Class C).
* Adrenal insufficiency.
* Clinically significant acute kidney injury within 12 weeks prior to the screening.
* New York Heart Association functional HF class IV at screening, or hospitalisation for heart failure within 4 weeks prior to screening.
* Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months) prior to screening.
* Solid organ or bone marrow transplant or a plan for transplant within 6 months following randomisation.
* Any use of the following medications and supplements:
1. MRAs
2. Aldosterone analogues
3. Aldosterone synthase inhibitors
4. Any use of potassium binders within 2 weeks prior to screening. Use is allowed after randomisation.
5. Strong or moderate inducers or inhibitors of CYP3A4, prohibited at least one week prior to randomisation
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