Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease

Part of paid clinical trials in Beverly Hills, California.

Sponsor
AstraZeneca
Study ID
NCT04595370
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD9977 — DRUG
    Participants will receive AZD9977 as per the arms they are randomized.
  • Dapagliflozin — DRUG
    Participants will receive dapagliflozin as per the arms they are randomized.

Study Details

The purpose of the study is to evaluate the efficacy and safety of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone and to assess the dose-response relationship, dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on urinary albumin to creatinine ratio (UACR). The study will be conducted in participants with heart failure (HF) with left ventricular ejection fraction (LVEF \[below 60%\]) and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR \[between ≥ 20 and ≤ 60 mL/min/1.73 m\^2, with at least 20% of participants with eGFR ≥ 20 to \<30 mL/min/1.73\^2 and a maximum of 35% of participants with eGFR ≥ 45 mL/min/1.73 m\^2\]).

Key Dates

Start date
Jan 26, 2021
Status verified
Oct 2024
Primary completion
Sep 22, 2023
Completion
Sep 22, 2023

Study Design

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

Arms

  • Experimental: AZD9977 Dose A + dapagliflozin 10 mg
    Participants will receive once daily oral dose A of AZD9977 and 10 mg dapagliflozin for 12 weeks.
  • Experimental: AZD9977 Dose B + dapagliflozin 10 mg
    Participants will receive once daily oral dose B of AZD9977 and 10 mg dapagliflozin for 12 weeks.
  • Experimental: AZD9977 Dose C + dapagliflozin 10 mg
    Participants will receive once daily oral dose C of AZD9977 and 10 mg dapagliflozin for 12 weeks.
  • Experimental: Dapagliflozin 10 mg
    Participants will receive once daily oral dose of dapagliflozin 10 mg alone for 12 weeks.

Primary Outcome Measure

Percent Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ]

Locations (26)

FacilityCityStateZIPSite coordinators
Research SiteBeverly HillsCalifornia90211-
Research SiteFountain ValleyCalifornia92708-
Research SiteNorthridgeCalifornia91324-
Research SiteSouth GateCalifornia90280-
Research SiteHialeahFlorida33016-
Research SiteHomesteadFlorida33032-
Research SiteJacksonvilleFlorida32216-
Research SiteMiamiFlorida33155-
Research SiteOcalaFlorida34474-
Research SiteTampaFlorida33603-
Research SiteAugustaGeorgia30904-
Research SiteColumbusGeorgia31904-
Research SiteBaltimoreMaryland21287-
Research SiteMethuenMassachusetts01844-
Research SiteSt LouisMissouri63136-
Research SiteThe BronxNew York10455-
Research SiteNew BernNorth Carolina28562-
Research SiteRapid CitySouth Dakota57701-
Research SiteMemphisTennessee38119-
Research SiteHoustonTexas77087-
Research SiteHoustonTexas77099-
Research SiteKingwoodTexas77339-
Research SiteMcKinneyTexas75069-
Research SiteSan AntonioTexas78207-
Research SiteShermanTexas75092-
Research SiteWebsterTexas77598-

Find similar trials in Beverly Hills, CA

By condition
Chronic kidney diseaseHeart failure
By specialty
NephrologyKidney diseaseCardiologyHeart disease
By research site
Research Site· Beverly Hills, CAResearch Site· Fountain Valley, CAResearch Site· Northridge, CAResearch Site· South Gate, CAResearch Site· Hialeah, FLResearch Site· Homestead, FL

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