A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function after Kidney Transplantation

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517568-48-00

Acronym

ALXN1210-DGF-321

Enrollment

164

Registered

2025-06-18

Start date

2025-07-21

Completion date

Unknown

Last updated

2025-09-23

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

Conditions

Delayed Graft Function after Kidney Transplantation

Brief summary

Time to freedom from dialysis through 90 days post-transplant

Detailed description

DGF incidence: Requirement of at least 1 dialysis session within the first 7 days post-transplant, Number of dialysis sessions through 90 days post-transplant, Time to first occurrence of eGFR ≥ 30 mL/min/1.73 m2 through 90 days post-transplant

Interventions

DRUGUltomiris 1

DRUG100 mg/11 mL concentrate for solution for infusion

DRUGAnti C5 Complement mAb Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to freedom from dialysis through 90 days post-transplant	—

Secondary

Measure	Time frame
DGF incidence: Requirement of at least 1 dialysis session within the first 7 days post-transplant, Number of dialysis sessions through 90 days post-transplant, Time to first occurrence of eGFR ≥ 30 mL/min/1.73 m2 through 90 days post-transplant	—

Countries

Austria, Czechia, Germany, Italy, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026