Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease (MIRACLE)

October 28, 2024 updated by: AstraZeneca

A Phase 2b, Randomised, Double-Blind, Active Controlled, Multi Centre Study to Evaluate the Efficacy, Safety and Tolerability of Oral AZD9977 and Dapagliflozin Treatment in Patients With Heart Failure and Chronic Kidney Disease

The purpose of the study is to evaluate the efficacy and safety of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone and to assess the dose-response relationship, dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on urinary albumin to creatinine ratio (UACR). The study will be conducted in participants with heart failure (HF) with left ventricular ejection fraction (LVEF [below 60%]) and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR [between ≥ 20 and ≤ 60 mL/min/1.73 m^2, with at least 20% of participants with eGFR ≥ 20 to <30 mL/min/1.73^2 and a maximum of 35% of participants with eGFR ≥ 45 mL/min/1.73 m^2]).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After screening, eligible participants will undergo a run-in period where all participants receive dapagliflozin for up to 7 weeks depending on pre-study use of SGLT2i or not. At the end of the run-in period, eligible participants will be randomly assigned with a 1:1:1:1 ratio to receive once daily administration of one of the following 4 study treatments group for 12 weeks. To ensure blinding, the study treatment will be administered in the form of 3 oral capsules of AZD9977 or placebo and 1 oral tablet or dapagliflozin.

  1. AZD9977 Dose A + dapagliflozin 10 mg
  2. AZD9977 Dose B + dapagliflozin 10 mg
  3. AZD9977 Dose C + dapagliflozin 10 mg
  4. Dapagliflozin 10 mg

Participants will be randomized to one of the above treatment group, according to type 2 diabetes mellitus [T2DM (yes/no)] and eGFR (≥ 20 to <30 mL/min/1.73^2; or ≥ 30 to < 45 mL/min/1.73^2; or ≥45 mL/min/1.73^2).

The total duration of participation will be approximately 22 to 24weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Roeselare, Belgium, 8800
        • Research Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Research Site
      • Plovdiv, Bulgaria, 4003
        • Research Site
      • Plovdiv, Bulgaria, 4002
        • Research Site
      • Plovdiv, Bulgaria, 1606
        • Research Site
      • Sofia, Bulgaria, 1431
        • Research Site
      • Sofia, Bulgaria, 1784
        • Research Site
      • Sofia, Bulgaria, 1233
        • Research Site
      • Sofia, Bulgaria, 1309
        • Research Site
      • Sofia, Bulgaria, 1510
        • Research Site
      • Veliko Turnovo, Bulgaria, 5000
        • Research Site
  • Canada
      • Quebec, Canada, G1R 2J6
        • Research Site
    • Ontario
      • Peterborough, Ontario, Canada, K9J 0B2
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Research Site
  • Czechia
      • Pardubice, Czechia, 532 03
        • Research Site
      • Praha 2, Czechia, 120 00
        • Research Site
      • Praha 5, Czechia, 158 00
        • Research Site
      • Uherske Hradiste, Czechia, 68601
        • Research Site
  • Denmark
      • Aarhus, Denmark, 8200
        • Research Site
      • Herlev, Denmark, 2730
        • Research Site
      • Svendborg, Denmark, 5700
        • Research Site
  • Germany
      • Dresden, Germany, 1307
        • Research Site
      • Frankfurt, Germany, 60313
        • Research Site
      • Jena, Germany, 07747
        • Research Site
      • Leipzig, Germany, 04103
        • Research Site
  • Hungary
      • Balatonfüred, Hungary, 8230
        • Research Site
      • Budapest, Hungary, 1122
        • Research Site
      • Budapest, Hungary, 1036
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Miskolc, Hungary, 3530
        • Research Site
      • Oroshaza, Hungary, H-5900
        • Research Site
  • India
      • Ahmedabad, India, 382421
        • Research Site
      • Chennai, India, 600081
        • Research Site
      • Kolkata, India, 700020
        • Research Site
      • Pune, India, 411011
        • Research Site
  • Italy
      • Roma, Italy, 00168
        • Research Site
  • Japan
      • Chuo-ku, Japan, 103-0027
        • Research Site
      • Hamada-shi, Japan, 697-8511
        • Research Site
      • Hamamatsu-shi, Japan, 430-0929
        • Research Site
      • Hanyu-shi, Japan, 348-8505
        • Research Site
      • Itabashi-ku, Japan, 173-8610
        • Research Site
      • Kasugai-shi, Japan, 487-0016
        • Research Site
      • Kawaguchi, Japan, 333-0842
        • Research Site
      • Kishiwada-shi, Japan, 596-8522
        • Research Site
      • Kobe, Japan, 654-0155
        • Research Site
      • Kobe-shi, Japan, 650-0047
        • Research Site
      • Matsudo-Shi, Japan, 271-0077
        • Research Site
      • Matsumoto-shi, Japan, 390-8621
        • Research Site
      • Ono, Japan, 675-1392
        • Research Site
      • Osaka-shi, Japan, 530-0001
        • Research Site
      • Sapporo-shi, Japan, 006-0811
        • Research Site
      • Sayama, Japan, 350-1305
        • Research Site
      • Takasago-shi, Japan, 676-0812
        • Research Site
      • Takasaki-shi, Japan, 370-0829
        • Research Site
      • Ueda-shi, Japan, 386-8610
        • Research Site
      • Yokohama-shi, Japan, 236-0004
        • Research Site
      • Yokohama-shi, Japan, 231-8682
        • Research Site
      • Yokohama-shi, Japan, 234-8503
        • Research Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Research Site
      • Gangwon-do, Korea, Republic of, 26426
        • Research Site
      • Seongnam-si, Korea, Republic of, 463-707
        • Research Site
      • Seoul, Korea, Republic of, 03080
        • Research Site
      • Seoul, Korea, Republic of, 06351
        • Research Site
      • Seoul, Korea, Republic of, 06591
        • Research Site
  • Lithuania
      • Kaunas, Lithuania, 50177
        • Research Site
      • Klaipeda, Lithuania, 92231
        • Research Site
      • Siauliai, Lithuania, LT-76231
        • Research Site
      • Vilnius, Lithuania, 08661
        • Research Site
  • Poland
      • Gdansk, Poland, 80-952
        • Research Site
      • Gdańsk, Poland, 80-382
        • Research Site
      • Katowice, Poland, 40-040
        • Research Site
      • Lublin, Poland, 20-709
        • Research Site
      • Ostrowiec Świętokrzyski, Poland, 27-400
        • Research Site
      • Oława, Poland, 55-200
        • Research Site
      • Oświęcim, Poland, 32-600
        • Research Site
      • Pabianice, Poland, 95-200
        • Research Site
      • Poznań, Poland, 60-702
        • Research Site
      • Skorzewo, Poland, 60-185
        • Research Site
      • Sopot, Poland, 81-717
        • Research Site
      • Szczecin, Poland, 71-434
        • Research Site
      • Toruń, Poland, 87-100
        • Research Site
      • Warszawa, Poland, 01-192
        • Research Site
      • Łódź, Poland, 92-213
        • Research Site
      • Łódź, Poland, 90-127
        • Research Site
      • Łódź, Poland, 95-513
        • Research Site
  • Russian Federation
      • Kazan, Russian Federation, 420101
        • Research Site
      • Kazan, Tatarstan, Russian Federation, 420012
        • Research Site
      • Kemerovo, Russian Federation, 650002
        • Research Site
      • Moscow, Russian Federation, 121552
        • Research Site
      • Moscow, Russian Federation, 125284
        • Research Site
      • Moscow, Russian Federation, 111539
        • Research Site
      • Moscow, Russian Federation, 129110
        • Research Site
      • Saint-Petersburg, Russian Federation, 195257
        • Research Site
      • St Petersburg, Russian Federation, 195067
        • Research Site
      • St. Petersburg, Russian Federation, 197022
        • Research Site
      • St. Petersburg, Russian Federation, 197089
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia, 974 01
        • Research Site
      • Brezno, Slovakia, 977 01
        • Research Site
      • Lucenec, Slovakia, 984 01
        • Research Site
      • Presov, Slovakia, 080 01
        • Research Site
      • Svidnik, Slovakia, 08901
        • Research Site
      • Trencin, Slovakia, 911 01
        • Research Site
  • Spain
      • Barcelona, Spain, 08003
        • Research Site
      • Coruña, Spain, 15006
        • Research Site
      • El Palmar, Spain, 30120
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
      • Santiago(A Coruña), Spain, 15706
        • Research Site
      • Sevilla, Spain, 41009
        • Research Site
      • Valencia, Spain, 46010
        • Research Site
      • Valencia, Spain, 46026
        • Research Site
  • Sweden
      • Goeteborg, Sweden, 413 46
        • Research Site
      • Stockholm, Sweden, 14186
        • Research Site
      • Stockholm, Sweden, 18288
        • Research Site
      • Uppsala, Sweden, 75185
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Research Site
      • Taichung, Taiwan, 40201
        • Research Site
      • Taipei, Taiwan, 10449
        • Research Site
      • Taipei, Taiwan, 11217
        • Research Site
      • Taipei City, Taiwan, 110
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Research Site
      • Bangkok, Thailand, 10700
        • Research Site
      • Chaingmai, Thailand, 50200
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
  • Turkey
      • Adana, Turkey, 01060
        • Research Site
      • Kocaeli, Turkey, 41380
        • Research Site
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76018
        • Research Site
      • Kharkiv, Ukraine, 61039
        • Research Site
      • Kyiv, Ukraine, 02091
        • Research Site
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Research Site
      • Fountain Valley, California, United States, 92708
        • Research Site
      • Northridge, California, United States, 91324
        • Research Site
      • S. Gate, California, United States, 90280
        • Research Site
    • Florida
      • Hialeah, Florida, United States, 33016
        • Research Site
      • Homestead, Florida, United States, 33032
        • Research Site
      • Jacksonville, Florida, United States, 32216
        • Research Site
      • Miami, Florida, United States, 33155
        • Research Site
      • Ocala, Florida, United States, 34474
        • Research Site
      • Tampa, Florida, United States, 33603
        • Research Site
    • Georgia
      • Augusta, Georgia, United States, 30904
        • Research Site
      • Columbus, Georgia, United States, 31904
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Research Site
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63136
        • Research Site
    • New York
      • Bronx, New York, United States, 10455
        • Research Site
    • North Carolina
      • New Bern, North Carolina, United States, 28562
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Research Site
    • Texas
      • Houston, Texas, United States, 77087
        • Research Site
      • Houston, Texas, United States, 77099
        • Research Site
      • Kingwood, Texas, United States, 77339
        • Research Site
      • McKinney, Texas, United States, 75069
        • Research Site
      • San Antonio, Texas, United States, 78207
        • Research Site
      • Sherman, Texas, United States, 75092
        • Research Site
      • Webster, Texas, United States, 77598
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants are included in the study if any of the following criteria apply:

  • Documented diagnosis of stable symptomatic HF (New York Heart Association class II-III) at screening, and a medical history of typical symptoms and signs of HF in those who are currently receiving loop diuretic treatment
  • Left ventricular ejection fraction <60% documented by the most recent echocardiogram or cardiac magnetic resonance imaging within the last 12 months prior to screening
  • Stable background treatment for HF, hypertension, diabetes mellitus or renal disease according to guidelines
  • N-terminal-pro-brain natriuretic peptide (NT proBNP) ≥300 pg/mL for participants with sinus rhythm at screening; and NT proBNP ≥600 pg/mL for participants with atrial fibrillation/flutter at screening
  • The eGFR ≥30 and ≤60 mL/min/1.73^2 (by CKD- EPI formula) and UACR ≥30 mg/g (3 mg/mmol) and <3000 mg/g (300 mg/mmol)
  • Body mass index less than 40 kg/m^2
  • Serum/plasma K+ level ≥ 3.5 and < 5.0 mmol/L within 10 days prior to randomization
  • Serum/ plasma Na+ level within normal reference values within 10 days prior to randomization
  • Systolic blood pressure should be at protocol defined range at randomization (Visit 3), with no change to antihypertensive treatments in previous 3 weeks
  • Male or female of non-childbearing potential
  • All participants must follow protocol defined contraceptives procedures

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Primary glomerulopathy, vasculitic renal disease, prior dialysis or unstable rapidly progressing renal disease, autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or anti-neutrophil cytoplasm antibody-associated vasculitis
  • Participants with currently decompensated HF requiring hospitalization for optimization of HF treatment and are not on stable HF therapy at the time of enrollment
  • HF due to cardiomyopathies
  • High output HF (e.g., due to hyperthyroidism or Paget's disease)
  • HF due to pericardial disease, congenital heart disease or clinically significant uncorrected primary cardiac valvular disease or planned cardiac valve repair/replacement
  • Participants with uncontrolled diabetes mellitus (Glycated hemoglobin >10%)
  • Participants with Type 1 diabetes mellitus
  • Intermittent or persistent 2nd or 3rd degree atrioventricular block, sinus node dysfunction with clinically significant bradycardia or sinus pauses, not treated with a pacemaker
  • History of any life-threatening cardiac dysrhythmia or uncontrolled ventricular rate in participants with atrial fibrillation or atrial flutter
  • Acute coronary syndrome and/or elective/non-elective percutaneous cardiac interventions (within 3 months) prior to randomisation or is planned to undergo any of these procedures during the study
  • Any major cardiovascular (eg, open chest, coronary artery bypass grafting or valvular repair/replacement) or major non-cardiovascular surgery within 3 months prior to randomisation or is planned to undergo any cardiovascular surgery during the study
  • Heart transplantation or left ventricular assist device at any time or if these are planned
  • Kidney or any organ transplantation or if these are planned
  • Medical conditions associated with development of hyperkalaemia (Addison's disease )
  • History or ongoing allergy/hypersensitivity, to sodium-glucose co-transporter-2 inhibitor (SGLT2i e.g., dapagliflozin, empagliflozin)
  • Stroke, transient ischemic attack, carotid surgery, or carotid angioplasty within previous 3 months prior to randomisation
  • Hepatic disease, including hepatitis and/or hepatic impairment (Child-Pugh class A-C), and aspartate aminotransferase or alanine transaminase or total bilirubin should be in protocol defined range at time of screening and/ or within 7 days prior to randomization
  • Participants with newly detected pathological laboratory values or an ongoing disease condition
  • If the participants clinical signs and symptoms consistent with COVID-19, and has been previously hospitalized with COVID-19 infection and did not fully recover their previous health status
  • Previous randomization in the present study
  • Prior medical treatment with an mineralocorticoid receptor antagonist where the medication was taken within 90 days prior to screening
  • Current or prior treatment within 6 months prior to screening with cytotoxic therapy, immunosuppressive therapy, or other immunotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AZD9977 Dose A + dapagliflozin 10 mg
Participants will receive once daily oral dose A of AZD9977 and 10 mg dapagliflozin for 12 weeks.
Drug: Dapagliflozin
Participants will receive dapagliflozin as per the arms they are randomized.
Drug: AZD9977
Participants will receive AZD9977 as per the arms they are randomized.
Experimental: AZD9977 Dose B + dapagliflozin 10 mg
Participants will receive once daily oral dose B of AZD9977 and 10 mg dapagliflozin for 12 weeks.
Drug: Dapagliflozin
Participants will receive dapagliflozin as per the arms they are randomized.
Drug: AZD9977
Participants will receive AZD9977 as per the arms they are randomized.
Experimental: AZD9977 Dose C + dapagliflozin 10 mg
Participants will receive once daily oral dose C of AZD9977 and 10 mg dapagliflozin for 12 weeks.
Drug: Dapagliflozin
Participants will receive dapagliflozin as per the arms they are randomized.
Drug: AZD9977
Participants will receive AZD9977 as per the arms they are randomized.
Experimental: Dapagliflozin 10 mg
Participants will receive once daily oral dose of dapagliflozin 10 mg alone for 12 weeks.
Drug: Dapagliflozin
Participants will receive dapagliflozin as per the arms they are randomized.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12
Time Frame: Baseline (Day 1) to Week 12
The effect of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone on UACR assessed. Urine samples were collected for the analysis of UACR. UACR (milligrams per gram [mg/g]) was calculated as 10 x urine albumin (mg per deciliter [mg/dL])/urine creatinine (g/dL). Change from baseline in UACR at the end of 12 weeks of study treatment was calculated as the average of the UACR values at Week 12 and was analyzed by a mixed-effects model for repeated measures (MMRM). Due to early removal of arms (AZD9977 150 mg monotherapy and Placebo), the study objectives were revised and the MMRM analysis included the 4 remaining arms (AZD9977 15 mg + Dapagliflozin, AZD9977 50 mg + Dapagliflozin, AZD9977 150 mg + Dapagliflozin, and Dapagliflozin 10 mg). Since 2 arms were removed from the study resulting in fewer participants only descriptive statistics are shown for those two arms without formal comparison.
Baseline (Day 1) to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at 12 Weeks to Assess Dose-Response Relationship
Time Frame: Baseline (Day 1) to Week 12
The dose-response relationship of dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on UACR was assessed. Urine samples were collected for the analysis of UACR. UACR (mg/g) was calculated as 10 x urine albumin (mg/dL)/urine creatinine (g/dL). Change from baseline in UACR at the end of 12 weeks of study treatment was calculated as the average of the UACR values at Week 12 and was analyzed by a mixed-effects model for repeated measures (MMRM). Due to early removal of arms (AZD9977 150 mg monotherapy and Placebo), the study objectives were revised and the MMRM analysis included the 4 remaining arms (AZD9977 15 mg + Dapagliflozin, AZD9977 50 mg + Dapagliflozin, AZD9977 150 mg + Dapagliflozin, and Dapagliflozin 10 mg). Since 2 arms were removed from the study resulting in fewer participants, only descriptive statistics was shown for those two arms without formal comparison.
Baseline (Day 1) to Week 12
Number of Participants With Adverse Events (AEs)
Time Frame: From baseline (Day 1) until Day 113
The safety and tolerability of AZD9977 combined with dapagliflozin 10 mg, AZD9977 monotherapy, dapagliflozin 10 mg monotherapy and placebo was assessed.
From baseline (Day 1) until Day 113
Change From Baseline in Serum Potassium (K+)
Time Frame: Baseline (Day 1) and Week 12
Effect of AZD9977 combined with dapagliflozin 10 mg, AZD9977 monotherapy, dapagliflozin 10 mg monotherapy and placebo on serum K+ was assessed.
Baseline (Day 1) and Week 12
Absolute Value of Serum Potassium Over Time
Time Frame: Baseline (Day 1) and Week 12
Effect of AZD9977 combined with dapagliflozin 10 mg, AZD9977 monotherapy, dapagliflozin 10 mg monotherapy and placebo on serum K+ was assessed.
Baseline (Day 1) and Week 12
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline (Day 1) and Week 12
Effect of AZD9977 combined with dapagliflozin 10 mg, AZD9977 monotherapy, dapagliflozin 10 mg monotherapy and placebo on eGFR was assessed.
Baseline (Day 1) and Week 12
Absolute Value of eGFR Over Time
Time Frame: Baseline (Day 1) to Week 12
Effect of all doses of AZD9977 combined with dapagliflozin 10 mg, AZD9977 monotherapy, dapagliflozin 10 mg monotherapy and placebo on eGFR was assessed
Baseline (Day 1) to Week 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: From baseline (Day 1) until Day 113 (Safety Follow-up)
Assessment of the general safety and tolerability of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone.
From baseline (Day 1) until Day 113 (Safety Follow-up)
Absolute value of serum potassium over time
Time Frame: Days 1, and 3 until Day 85
Assessment of the effect of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone on serum potassium.
Days 1, and 3 until Day 85
Change from baseline in serum potassium over time
Time Frame: From baseline (Day 1), Day 3 until Day 85
Assessment of the effect of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone on serum potassium.
From baseline (Day 1), Day 3 until Day 85
Absolute value of eGFR over time
Time Frame: Days 1, and 3 until Day 85
Assessment of the effect of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone on eGFR.
Days 1, and 3 until Day 85
Change from baseline in eGFR over time
Time Frame: From baseline (Day 1), Day 3 until Day 85
Assessment of the effect of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone on eGFR.
From baseline (Day 1), Day 3 until Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John McMurray, University of Glasgow, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D6402C00001
  • 2020-003126-23 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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