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AZD9977 for Chronic Kidney Disease (MIRACLE Trial)

Phase 2
Waitlist Available
Led By John McMurray
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) until week 12 (day 85)
Awards & highlights

MIRACLE Trial Summary

This trial will compare the effect of a new drug, AZD9977, when used with dapagliflozin, to dapagliflozin used alone, in people with heart failure and chronic kidney disease. The trial will also look at different doses of AZD9977 to see what effect it has.

Eligible Conditions
  • Chronic Kidney Disease
  • Heart Failure

MIRACLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) until week 12 (day 85)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) until week 12 (day 85) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent change from baseline in UACR at 12 weeks
Secondary outcome measures
Percent change from baseline in UACR at 12 weeks to assess dose-response relationship
Other outcome measures
Absolute value of eGFR over time
Absolute value of serum potassium over time
Change from baseline in eGFR over time
+2 more

MIRACLE Trial Design

4Treatment groups
Experimental Treatment
Group I: Dapagliflozin 10 mgExperimental Treatment1 Intervention
Participants will receive once daily oral dose of dapagliflozin 10 mg alone for 12 weeks.
Group II: AZD9977 Dose C + dapagliflozin 10 mgExperimental Treatment2 Interventions
Participants will receive once daily oral dose C of AZD9977 and 10 mg dapagliflozin for 12 weeks.
Group III: AZD9977 Dose B + dapagliflozin 10 mgExperimental Treatment2 Interventions
Participants will receive once daily oral dose B of AZD9977 and 10 mg dapagliflozin for 12 weeks.
Group IV: AZD9977 Dose A + dapagliflozin 10 mgExperimental Treatment2 Interventions
Participants will receive once daily oral dose A of AZD9977 and 10 mg dapagliflozin for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD9977
2019
Completed Phase 2
~240
Dapagliflozin
2014
Completed Phase 4
~64440

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,294 Previous Clinical Trials
288,620,527 Total Patients Enrolled
John McMurrayPrincipal InvestigatorUniversity of Glasgow, United Kingdom

Media Library

AZD9977 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04595370 — Phase 2
Chronic Kidney Disease Research Study Groups: AZD9977 Dose C + dapagliflozin 10 mg, Dapagliflozin 10 mg, AZD9977 Dose A + dapagliflozin 10 mg, AZD9977 Dose B + dapagliflozin 10 mg
Chronic Kidney Disease Clinical Trial 2023: AZD9977 Highlights & Side Effects. Trial Name: NCT04595370 — Phase 2
AZD9977 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04595370 — Phase 2
~35 spots leftby Jun 2025