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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)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523994-41-00
Enrollment
260
Registered
2026-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease (CKD) in adults, with specified ranges of eGFR and albuminuria (UACR), irrespective of T2DM status; background SGLT2i dapagliflozin 10 mg as GDMT.

Brief summary

Time to first occurrence of any component of the composite of: ≥50% sustained decline in eGFR, end-stage kidney disease (ESKD; sustained eGFR <10 mL/min/1.73 m2, chronic dialysis, or renal transplant), or all-cause mortality.

Detailed description

Time to first occurrence of composite of ≥50% sustained decline in eGFR, ESKD, or CV and renal death., Time to composite of all-cause mortality, MI, or stroke., Time to 3-point MACE (CV death, MI, stroke)., Time to all-cause mortality., Time to CV death., Time to first occurrence of any component of pure renal composite: ≥50% sustained decline in eGFR, ESKD, or renal death., Time to composite of CV death or hospitalization for HF (hHF)., Time to composite of CV death MI, stroke, or HF hospitalizations., Time to all-cause hospitalization.

Interventions

DRUGForxiga 10 mg film-coated tablets

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to first occurrence of any component of the composite of: ≥50% sustained decline in eGFR, end-stage kidney disease (ESKD; sustained eGFR <10 mL/min/1.73 m2, chronic dialysis, or renal transplant), or all-cause mortality.

Secondary

MeasureTime frame
Time to first occurrence of composite of ≥50% sustained decline in eGFR, ESKD, or CV and renal death., Time to composite of all-cause mortality, MI, or stroke., Time to 3-point MACE (CV death, MI, stroke)., Time to all-cause mortality., Time to CV death., Time to first occurrence of any component of pure renal composite: ≥50% sustained decline in eGFR, ESKD, or renal death., Time to composite of CV death or hospitalization for HF (hHF)., Time to composite of CV death MI, stroke, or HF hospitalizations., Time to all-cause hospitalization.

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 25, 2026