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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
~64880

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,633 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current population enrolled in this research project?

"Affirmative. Clinicaltrials.gov indicates that this trial, first posted on January 26th 2021, is in the process of recruiting individuals to participate. Altogether, 500 patients must be found from 33 distinct sites for successful completion of the study."

Answered by AI

Are there any vacant slots remaining in this trial for participants?

"Clinicaltrials.gov confirms that this clinical trial is in the process of recruiting participants, with a post date of January 26th 2021 and an edit on November 22nd 2022."

Answered by AI

Has Dapagliflozin been explored by other researchers in the past?

"The University of Texas Health Science Center at San Antonio initially conducted research on dapagliflozin in 2014. Presently, there are 18460 completed trials and 63 active ones taking place primarily around Poughkeepsie, New york."

Answered by AI

Is this a pioneering endeavor in its respective field?

"As of today, Dapagliflozin is a N/A approved drug after its first clinical trial in 2014. Sponsored by AstraZeneca and involving 700 individuals, it has since been studied extensively with 63 active trials conducted across 235 cities and 50 nations."

Answered by AI

Is this research enrolled individuals of advanced age?

"The requirements for this study indicate that suitable candidates must be aged between 21 and 130. Additionally, there are 68 studies available to those under 18 while 1191 exist specifically tailored towards participants above 65 years of age."

Answered by AI

Is enrollment currently open to join this research trial?

"Admission to this study requires individuals of ages between 21 and 130 years old that are suffering from cardiac failure. Aspiring participants must be cognizant that 500 spots are available in total."

Answered by AI

What ailments does Dapagliflozin typically ameliorate?

"Dapagliflozin is frequently prescribed to treat pharmaceutical preparations, but it can also provide benefits for patients with diet-related issues, an exercise regimen that does not yield the desired results, and those who do not respond well to single therapy."

Answered by AI

Does Dapagliflozin exhibit any potentially dangerous side effects?

"While the efficacy of Dapagliflozin is still uncertain, clinical data does suggest safety, so our team at Power gave it a score of 2."

Answered by AI

How many health facilities are currently administering this trial in the state?

"At present, 33 medical centres are actively recruiting for this clinical trial. Prospective patients can select from a variety of locations including Poughkeepsie, New Bern and Augusta - to name but a few. It is important to choose the closest site in order to decrease travel requirements if you decide to partake in the study."

Answered by AI

Who else is applying?

What state do they live in?
Arkansas
Florida
Texas
How old are they?
18 - 65
65+
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~37 spots leftby Apr 2025