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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
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1) until week 12 (day 85)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) until week 12 (day 85)
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 moreTrial 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
4,302 Previous Clinical Trials
288,624,446 Total Patients Enrolled
John McMurrayPrincipal InvestigatorUniversity of Glasgow, United Kingdom
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have Type 1 diabetes.You have a history of dangerous heart rhythm problems or uncontrolled rapid heart rate if you have atrial fibrillation or atrial flutter.You have had a stroke, mini-stroke, or surgery on your carotid artery within the past 3 months.You have taken a certain type of medication called a mineralocorticoid receptor antagonist within the last 90 days.Your body weight is not extremely high for your height.You have had an allergic reaction or sensitivity to a medication called SGLT2 inhibitor, like dapagliflozin or empagliflozin.You have a condition called high output heart failure, which can be caused by conditions like hyperthyroidism or Paget's disease.You have a heart condition that causes slow or irregular heartbeats, and you are not using a pacemaker to help regulate your heart.
Research Study Groups:
This trial has the following groups:- Group 1: AZD9977 Dose C + dapagliflozin 10 mg
- Group 2: Dapagliflozin 10 mg
- Group 3: AZD9977 Dose A + dapagliflozin 10 mg
- Group 4: AZD9977 Dose B + dapagliflozin 10 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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