A trial to learn how well balcinrenone in combination with dapagliflozin works and how safe it is compared to dapagliflozin alone in adults with chronic kidney disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Metabolism [G03]

Trial duration

30 Jul 2024 → 10 May 2025

Decision date (initial)

2024-07-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacodynamic, Dose response, Pharmacokinetic, Others, Efficacy

To determine whether balcinrenone in combination with dapagliflozin is superior to dapagliflozin in reducing albuminuria.

Conditions and MedDRA coding

Chronic Kidney Disease and Albuminuria

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Age ≥ 18 years old
2. 2.Diagnosis of CKD and eGFR ≥ 25 to < 60 mL/min/1.73 m2.
3. 3. UACR > 100 mg/g (10 mg/mmol) to ≤ 5000 mg/g (500 mg/mmol).
4. 4. Serum potassium ≥ 3.5 mmol/L to ≤ 5.0 mmol/L.
5. 5. Stable RAAS inhibitors treatment for 4 weeks before screening. Participants who cannot tolerate or are not treated with RAAS inhibitors can also participate in the study.

Exclusion criteria 13

1. 1. Uncontrolled arterial hypertension (SBP > 160 mmHg or DBP > 100 mmHg).
2. 10. Hepatic disease, including active hepatitis, and/or hepatic impairment (Child-Pugh class B-C; or any of AST or ALT > 3 × ULN; or TBL > 2 × ULN.
3. 11. Serum HCO3 < 18 mmol/L at screening.
4. 12. Adrenal insufficiency (eg, Addison's disease, prolonged use of glucocorticoids).
5. 2. Hypotension defined as SBP < 100 mmHg.
6. 3. Diagnosis of lupus nephritis or antineutrophil cytoplasmic antibody-associated vasculitis. Other nephropathies that are unstable, or progress rapidly, or require cytotoxic or immunomodulatory therapy.
7. 4. Cytotoxic or immunomodulatory therapy within 6 months prior to screening, or current, or planned within 6 months following randomization.
8. 5. Diagnosis of autosomal dominant polycystic kidney disease
9. 6. History of solid organ or bone marrow transplantation.
10. 7. Recent (90 d prior to screening) or ongoing dialysis, or likely need for dialysis within 3 months following randomization.
11. 8. Acute coronary syndrome (myocardial infarction or unstable angina), stroke, transient ischaemic attack within 12 weeks prior to randomisation (Visit 2).
12. 9. Type 1 diabetes mellitus (DM) or uncontrolled type 2 DM.
13. 13. Any use of the following within 4 weeks prior to screening: - MRA (or planned initiation of MRA treatment), potassium sparing diuretic, potassium binders, fludrocortisone. - Strong or moderate CYP3A4 inducers or inhibitors prohibited at least 1 week prior to randomisation and during treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Relative change in UACR from baseline to Week 12

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Centre

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Centre

Locations

5 EU/EEA countries · 33 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 45 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications