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A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease.
7000 patients around the world
Available in Spain, Argentina, Brazil, Chile, Peru, United States
AstraZeneca
7000Patients around the world
This study is for people with
Renal disease
Chronic kidney disease
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Adults with confirmed CKD; UACR ≥30 mg/g and eGFR ≥20 mL/min/1.73 m² within specified ranges.On stable, patient maximum tolerated, labeled daily dose of ACEI or ARB for ≥4 weeks at least 28 days before screening.
- BMI <23 kg/m² at screening.History of type 1 diabetes mellitus.HbA1c ≥10% (86 mmol/mol) at screening.Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema.Have had more than one episode of severe hypoglycemia within 180 days prior to screening, or hypoglycemia unawareness.Acute coronary syndrome, major cardiac procedure, stroke, or TIA within 3 months prior to screening.Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying.History of acute or chronic pancreatitis.History/family history (first degree) of medullary thyroid cancer or MEN2.
StudyElevate-CKD
SponsorAstraZeneca
Study typeInterventional
Conditions
Chronic kidney disease
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07753993
