Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease

Part of paid clinical trials in Sheffield, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06350123
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD.

Key Dates

First listed
Apr 5, 2024
Start date
May 1, 2024
Status verified
Jun 2026
Primary completion
May 9, 2025
Completion
May 9, 2025

Study Design

Enrollment
324 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Balcinrenone/dapagliflozin 15 mg/10 mg
    Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
  • Experimental: Balcinrenone/dapagliflozin 40 mg/10 mg
    Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
  • Active Comparator: Dapagliflozin 10 mg
    Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin

Primary Outcome Measure

Relative Change in Urine Albumin-to-Creatinine Ratio (UACR) From Baseline to Week 12 [ Time Frame: Baseline (Day 1) until Week 12 (Day 85) ]

Locations (15)

FacilityCityStateZIPSite coordinators
Research SiteSheffieldAlabama35660-
Research SiteGlendaleCalifornia91206-
Research SiteWaterburyConnecticut06708-
Research SiteHialeahFlorida33012-
Research SiteMiami LakesFlorida33014-
Research SiteAnnapolisMaryland21401-
Research SiteNew BernNorth Carolina28562-
Research SiteEl PasoTexas79935-
Research SiteHoustonTexas77079-
Research SiteHoustonTexas77099-
Research SiteSan AntonioTexas78212-
Research SiteOgdenUtah84405-
Research SiteSalt Lake CityUtah84115-
Research SiteSalt Lake CityUtah84124-
Research SiteNorfolkVirginia23504-

Related coverage on Hipa.ai

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By condition
Chronic kidney disease
By specialty
NephrologyKidney disease

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