Phase 3 Study of Ravulizumab versus Placebo in Adult Participants at High Risk of DGF after Kidney Transplantation

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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051250092

Enrollment

450

Registered

2025-08-19

Start date

2025-08-15

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

suppression of delayed graft function

Interventions

Lablizumab (genetically recombined) or placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. >= 18 years of age at the time of signing the informed consent. 2. Diagnosed with dialysis-dependent ESKD 3. A candidate for kidney transplant from 1 of the following: a. DCD donor; b. DBD donor with KDPI score of >= 60%

Exclusion criteria

Exclusion criteria: 1. Is to receive a kidney from a donor with category I, II, IV and V Maastricht Classification 2. Diagnosed with Acute Kidney Injury (AKI) of Stage 3 severity according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines

Design outcomes

Primary

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

Secondary

Measure	Time frame
(1) DGF incidence: Requirement of at least 1 dialysis session within the first 7 days post-transplant. (2) Number of dialysis sessions through 90 days post-transplant. (3) Time to first occurrence of eGFR >= 30 mL/min/1.73 m2 through 90 days post-transplant	—

Countries

Argentina, Australia, Austria, Brazil, Canada, China, Czechia, France, Germany, Italy, Japan, Korea, Poland, Portugal, Spain, Taiwan, UK, US

Contacts

Public ContactAkiko Matsusaki

Alexion Pharma GK

JPDept-DevOps-PMCO@alexion.com+81-3-3457-9559

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026