A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease

Part of paid clinical trials in Canoga Park, California.

Sponsor
AstraZeneca
Study ID
NCT04492722
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • AZD5718 — DRUG
    Participants will receive once daily oral dose of AZD5718 as per the arms they are randomised, and will continue until Week 20.
  • Dapagliflozin 10 mg — DRUG
    Participants will receive once daily oral dose of 10 mg dapagliflozin for 8 weeks as an add-on therapy.
  • Placebo — DRUG
    Participants will receive once daily oral dose of placebo matched to AZD5718, and will continue until Week 20.

Study Details

The purpose of the study is to evaluate the dose-response efficacy, safety, and pharmacokinetics (PK) of AZD5718 in participants with proteinuric chronic kidney disease.

Key Dates

Start date
Oct 1, 2020
Status verified
Nov 2024
Primary completion
Sep 6, 2022
Completion
Sep 6, 2022

Study Design

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

Arms

  • Experimental: AZD5718 Dose 1 + Dapagliflozin 10 mg
    Participants will receive once daily oral dose 1 of AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.
  • Experimental: AZD5718 Dose 2 + Dapagliflozin 10 mg
    Participants will receive once daily oral dose 2 of AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.
  • Experimental: AZD5718 Dose 3 + Dapagliflozin 10 mg
    Participants will receive once daily oral dose 3 of AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.
  • Placebo Comparator: Placebo + Dapagliflozin 10 mg
    Participants will receive once daily oral dose of placebo matched to AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.

Primary Outcome Measure

Change From Baseline in Reduction of Urine Albumin to Creatinine Ratio (ACR) to Week 20 [ Time Frame: Week 1 (Baseline) to Week 20 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Research SiteCanoga ParkCalifornia91303-
Research SiteLa MesaCalifornia91942-
Research SiteSan CarlosCalifornia94070-
Research SiteSan FranciscoCalifornia94110-
Research SiteVictorvilleCalifornia92392-
Research SiteDenverColorado80045-
Research SiteJacksonvilleFlorida32216-
Research SiteWinter HavenFlorida33880-
Research SiteColumbusGeorgia31904-
Research SiteRosevilleMichigan48066-
Research SiteHazelwoodMissouri63042-
Research SiteFresh MeadowsNew York11365-
Research SiteGreat NeckNew York11021-
Research SiteJamaicaNew York11432-
Research SiteBlue AshOhio45242-
Research SiteEast ProvidenceRhode Island02914-
Research SiteMemphisTennessee38104-2127-
Research SiteAustinTexas78738-
Research SiteHoustonTexas77099-
Research SitePearlandTexas77584-
Research SiteSan AntonioTexas78215-
Research SiteSchertzTexas78154-

Find similar trials in Canoga Park, CA

By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
Research Site· Canoga Park, CAResearch Site· La Mesa, CAResearch Site· San Carlos, CAResearch Site· San Francisco, CAResearch Site· Victorville, CAResearch Site· Denver, CO

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