RECRUITING

A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure

Official Title

A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure

Quick Facts

Study Start:2025-03-03
Study Completion:2030-04-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06742723

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.

Ages Eligible for Study:18 Years to 130 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
  2. 2. Participants with:
  3. 1. eGFR ≥ 30 and \< 60 mL/min/1.73 m2 (local or central laboratory values) AND UACR ≥ 30 mg/g (3.39 mg/mmol) and \< 500 mg/g (56.5 mg/mmol) (central laboratory values only), or
  4. 2. eGFR ≥ 30 and ≤ 75 mL/min/1.73 m2 (local or central laboratory values) AND UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) or UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local or central laboratory values).
  5. 3. \[obsolete\]
  6. 4. Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.
  7. 5. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.
  8. 6. Participants with:
  9. 1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values).
  10. 2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR \< 45 mL/min/1.73 m2 (local or central laboratory values).
  1. 1. Systolic blood pressure \> 180 mmHg, or diastolic BP \> 110 mmHg at screening.
  2. 2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months prior to screening.
  3. 3. Serum sodium \< 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).
  4. 4. T1DM:
  5. 1. For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion.
  6. 2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Fairhope, Alabama, 36532
United States
Research Site
Surprise, Arizona, 85374
United States
Research Site
Beverly Hills, California, 90211
United States
Research Site
Fremont, California, 94538
United States
Research Site
Fullerton, California, 92835
United States
Research Site
Los Alamitos, California, 90720
United States
Research Site
San Francisco, California, 94110
United States
Research Site
Tarzana, California, 91356
United States
Research Site
New Britain, Connecticut, 06051
United States
Research Site
Boca Raton, Florida, 33487
United States
Research Site
Boynton Beach, Florida, 33435
United States
Research Site
Edgewater, Florida, 32132
United States
Research Site
Fort Lauderdale, Florida, 33316
United States
Research Site
Hollywood, Florida, 33021
United States
Research Site
Jacksonville Beach, Florida, 32250
United States
Research Site
Melbourne, Florida, 32901
United States
Research Site
Miami Lakes, Florida, 33014
United States
Research Site
Ocoee, Florida, 34761
United States
Research Site
Port Charlotte, Florida, 33952
United States
Research Site
Port Orange, Florida, 32127
United States
Research Site
Riverview, Florida, 33578
United States
Research Site
Winter Haven, Florida, 33880
United States
Research Site
Atlanta, Georgia, 30344
United States
Research Site
Augusta, Georgia, 30904
United States
Research Site
Austell, Georgia, 30106
United States
Research Site
Brunswick, Georgia, 31520
United States
Research Site
Conyers, Georgia, 30094
United States
Research Site
Riverdale, Georgia, 30274
United States
Research Site
Honolulu, Hawaii, 96814
United States
Research Site
Champaign, Illinois, 61822
United States
Research Site
Maywood, Illinois, 60153
United States
Research Site
Rockford, Illinois, 61107
United States
Research Site
Evansville, Indiana, 47714
United States
Research Site
Iowa City, Iowa, 52242
United States
Research Site
West Des Moines, Iowa, 50266
United States
Research Site
Hutchinson, Kansas, 67502
United States
Research Site
Kansas City, Kansas, 66112
United States
Research Site
Wichita, Kansas, 67214
United States
Research Site
Metairie, Louisiana, 70006
United States
Research Site
West Monroe, Louisiana, 71291
United States
Research Site
Boston, Massachusetts, 02114
United States
Research Site
Boston, Massachusetts, 02115
United States
Research Site
New Bedford, Massachusetts, 02740
United States
Research Site
Ann Arbor, Michigan, 48109
United States
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Detroit, Michigan, 48202
United States
Research Site
Garden City, Michigan, 48135
United States
Research Site
Saint Joseph, Michigan, 49085
United States
Research Site
Kansas City, Missouri, 64111
United States
Research Site
Kansas City, Missouri, 64151
United States
Research Site
Saint Louis, Missouri, 63136
United States
Research Site
Norfolk, Nebraska, 68701
United States
Research Site
Eatontown, New Jersey, 07724
United States
Research Site
Albany, New York, 12208
United States
Research Site
New York, New York, 10016
United States
Research Site
Greenville, North Carolina, 27834
United States
Research Site
Hickory, North Carolina, 28601
United States
Research Site
Jacksonville, North Carolina, 28546
United States
Research Site
Kinston, North Carolina, 28504
United States
Research Site
Morehead City, North Carolina, 28557
United States
Research Site
New Bern, North Carolina, 28562
United States
Research Site
Rocky Mount, North Carolina, 27804
United States
Research Site
Sanford, North Carolina, 27330
United States
Research Site
Statesville, North Carolina, 28625
United States
Research Site
Wilmington, North Carolina, 28401
United States
Research Site
Wilmington, North Carolina, 28412
United States
Research Site
Winston-Salem, North Carolina, 27103
United States
Research Site
Canton, Ohio, 44718
United States
Research Site
Cincinnati, Ohio, 45212
United States
Research Site
Cincinnati, Ohio, 45219
United States
Research Site
Columbus, Ohio, 43210
United States
Research Site
Columbus, Ohio, 43213
United States
Research Site
Columbus, Ohio, 43215
United States
Research Site
Chester, Pennsylvania, 19013
United States
Research Site
East Providence, Rhode Island, 02914
United States
Research Site
Providence, Rhode Island, 02904
United States
Research Site
Columbia, South Carolina, 29203
United States
Research Site
Knoxville, Tennessee, 37912
United States
Research Site
Knoxville, Tennessee, 37938
United States
Research Site
Nashville, Tennessee, 37232
United States
Research Site
Arlington, Texas, 76015
United States
Research Site
Austin, Texas, 78726
United States
Research Site
Austin, Texas, 78735
United States
Research Site
Dallas, Texas, 75234
United States
Research Site
Dallas, Texas, 75246
United States
Research Site
Houston, Texas, 77004
United States
Research Site
Houston, Texas, 77099
United States
Research Site
Humble, Texas, 77338
United States
Research Site
Lewisville, Texas, 75057
United States
Research Site
Pasadena, Texas, 77504
United States
Research Site
Pearland, Texas, 77584
United States
Research Site
San Antonio, Texas, 78212
United States
Research Site
Arlington, Virginia, 22205
United States
Research Site
Manassas, Virginia, 20110
United States
Research Site
Newport News, Virginia, 23606
United States
Research Site
Woodbridge, Virginia, 22192
United States
Research Site
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: AstraZeneca

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 Registration Dates

Study Start Date2025-03-03
Study Completion Date2030-04-18

Study Record Updates

Study Start Date2025-03-03
Study Completion Date2030-04-18

Terms related to this study

Keywords Provided by Researchers

  • Chronic kidney disease
  • Hypertension
  • Blood pressure
  • Baxdrostat
  • Dapagliflozin
  • Event-Driven
  • Outcome

Additional Relevant MeSH Terms

  • Chronic Kidney Disease and Hypertension