NCT06830798 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
| NCT ID | NCT06830798 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Alexion Pharmaceuticals, Inc. |
| Condition | Delayed Graft Function |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 450 participants in total. It began in 2025-05-19 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this study is to demonstrate the efficacy of ravulizumab vs placebo in reducing the severity of DGF as measured by time to freedom from dialysis in adult participants who are at high risk of DGF after undergoing transplant of deceased donor kidney.
Eligibility Criteria
Inclusion Criteria: * ≥ 18 years of age at the time of signing the informed consent * Diagnosed with Dialysis-dependent End-Stage Kidney Disease (ESKD) * A candidate for kidney transplant from: 1. Donation after Circulatory Death (DCD) donor 2. High-risk Donation after Brain Death (DBD) donor Exclusion Criteria: * Is to receive a kidney from a donor with category I,II,IV and V Maastricht Classification * Diagnosed with Acute Kidney Injury (AKI) of Stage 3 severity according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06830798 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Delayed Graft Function. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06830798 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 450 participants.
Is NCT06830798 currently recruiting?
Yes, NCT06830798 is actively recruiting participants. Contact the research team at clinicaltrials@alexion.com for enrollment information.
Where is the NCT06830798 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, San Francisco, United States, San Francisco, United States and 11 additional locations.
Who is sponsoring the NCT06830798 clinical trial?
NCT06830798 is sponsored by Alexion Pharmaceuticals, Inc.. The trial plans to enroll 450 participants.