A Phase 2b Diabetic Kidney Disease Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT04170543
Phase
PHASE2
Status
Completed

Conditions

  • Diabetic Kidney Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 101 Years
Healthy Volunteers
Not accepted

Interventions

  • MEDI3506 — DRUG
    Dose 1, Dose 2, Dose 3, Dose 4
  • Placebo — DRUG
    Placebo
  • Dapagliflozin — DRUG
    Dapagliflozin 10 mg

Study Details

A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease

Key Dates

Start date
Nov 18, 2019
Status verified
Jul 2024
Primary completion
May 16, 2023
Completion
May 16, 2023

Study Design

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

Arms

  • Experimental: Group 1
    MEDI3506 Dose 1 plus Dapagliflozin (Day 85 to Day 168).
  • Experimental: Group 2
    MEDI3506 Dose 2 plus Dapagliflozin (Day 85 to Day 168).
  • Experimental: Group 3
    MEDI3506 Dose 3 plus Dapagliflozin (Day 85 to Day 168).
  • Experimental: Group 4
    MEDI3506 Dose 4 plus Dapagliflozin (Day 85 to Day 168).
  • Placebo Comparator: Group 5
    Placebo (volume matched) plus Dapagliflozin (Day 85 to Day 168).

Primary Outcome Measure

Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population [ Time Frame: From baseline to Day 169 ]

Locations (49)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35209-
Research SiteHuntsvilleAlabama35805-
Research SiteMesaArizona85210-
Research SiteAlhambraCalifornia91801-
Research SiteGlendaleCalifornia91204-
Research SiteGranada HillsCalifornia91344-
Research SiteHuntington ParkCalifornia90255-
Research SiteNorthridgeCalifornia91324-
Research SiteSacramentoCalifornia95821-
Research SiteSan DiegoCalifornia92123-
Research SiteSan DimasCalifornia91773-
Research SiteVacavilleCalifornia95687-
Research SiteFleming IslandFlorida32003-
Research SiteHialeahFlorida33016-
Research SiteJacksonvilleFlorida32204-
Research SiteMiamiFlorida33015-
Research SiteAtlantaGeorgia30338-
Research SiteHonoluluHawaii96814-
Research SiteChicagoIllinois60607-
Research SiteChicagoIllinois60643-
Research SiteIowa CityIowa52242-
Research SiteManhattanKansas66502-
Research SiteTopekaKansas66606-
Research SiteWichitaKansas67214-
Research SiteFlintMichigan48504-
Research SiteHendersonNevada89014-
Research SiteLas VegasNevada89129-
Research SiteBerlinNew Jersey08009-
Research SiteCharlotteNorth Carolina28204-
Research SiteGreensboroNorth Carolina27408-
Research SiteGreenvilleNorth Carolina27834-
Research SiteMorehead CityNorth Carolina28557-
Research SiteMaumeeOhio43537-
Research SiteOklahoma CityOklahoma73116-
Research SiteBethlehemPennsylvania18017-
Research SiteEast ProvidenceRhode Island02915-
Research SiteColumbiaSouth Carolina29203-
Research SiteMemphisTennessee38119-
Research SiteCypressTexas77429-
Research SiteHoustonTexas77004-
Research SiteHoustonTexas77079-
Research SiteKatyTexas77450-
Research SiteSan AntonioTexas78212-
Research SiteSan AntonioTexas78229-
Research SiteSan AntonioTexas78251-
Research SiteSt. GeorgeUtah84790-
Research SiteBurkeVirginia22015-
Research SiteTacomaWashington98405-
Research SiteMorgantownWest Virginia26506-

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