Chronic Kidney Disease
Conditions
Keywords
Chronic kidney disease, Elecoglipron
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.
Interventions
DRUGElecoglipron
Elicoglipron tablet
DRUGPlacebo
Placebo tablet
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Placebo controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 \- CV and renal death |
| 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 | Time to the first occurrence of any component of this composite: * All-cause mortality * MI * Stroke |
| 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 | Time to the first occurrence of any component of this composite: * CV and renal death * MI * Stroke |
| 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 | Time to death from any cause |
| 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 | Time to death from CV cause |
| 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 | 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 \- Renal death |
| 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 | Time to the first occurrence of any component of this composite: * CV death * HF hospitalizations (hHF) |
| 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 | Time to first occurrence of any component of this composite: * CV death * MI * Stroke * HF hospitalizations (hHF) |
| 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 | Time to hospitalization for any cause |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Czechia, Denmark, Finland, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Norway, Peru, Philippines, Poland, Romania, Serbia, South Korea, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States, Vietnam
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed