NCT07753993RecruitingPhase 3
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants With Chronic Kidney Disease (Elevate-CKD)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 7,000
- Locations
- 715
- Primary Endpoint
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or all-cause mortality
Study Overview
Brief Summary
This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled multicenter study to investigate outcomes with elecoglipron compared with placebo in participants with CKD with and without T2DM who are on background SGLT2i (dapagliflozin) as GDMT and other SoC treatments for CKD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Placebo controlled
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Placebo
Active Comparator
Placebo matching Elecoglipron tablet once daily
Intervention: Placebo (Drug)
Elecoglipron
Experimental
Elecoglipron tablet once daily
Intervention: Elecoglipron (Drug)
Outcomes
Primary Outcomes
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or all-cause mortality
Time Frame: Event-driven, trial is estimated to be up to 4.5 years
Time to the first occurrence of any component of this composite: * ≥ 50% sustained decline in eGFR * ESKD defined as sustained eGFR \< 10 mL/min/1.73 m2, or Chronic dialysis treatment, or Receiving a renal transplant * All-cause mortality
Secondary Outcomes
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of composite of all-cause mortality, MI, or stroke(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of MACE (CV death, MI, or stroke)(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of all-cause mortality(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HF hospitalizations(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite endpoint of CV death, MI, stroke, or HF hospitalizations(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of all-cause hospitalization(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or CV and renal death(Event-driven, trial is estimated to be up to 4.5 years)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the pure renal composite of ≥ 50% sustained decline in eGFR, ESKD, or renal death(Event-driven, trial is estimated to be up to 4.5 years)
Investigators
Study Sites (715)
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