Balcinrenone/Dapagliflozin for Chronic Kidney Disease

A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)

Recruiting Phase 3 Interventional Study
Renal Insufficiency, Chronic
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.
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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 out Type 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.

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About This Trial
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 …
Trial Locations
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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 \…
Contacts

AstraZeneca Clinical Study Information Center

+18772409479

information.center@astrazeneca.com

CONTACT

AstraZeneca Clinical AstraZeneca Clinical

+18772409479

information.center@astrazeneca.com

CONTACT