Evaluating Ravulizumab for Reducing Delayed Graft Function After Kidney Transplant
Official title: 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
Run by Alexion Pharmaceuticals, Inc. · NCT06830798 · Data updated 2026-11-12
This study is testing if a new drug called ravulizumab can help kidney transplant patients avoid delayed graft function and reduce the need for dialysis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | Alexion Pharmaceuticals, Inc. Industry-sponsored |
| Drugs / interventions | ravulizumab |
| Locations | 130 sites (Phoenix, Arizona and 129 other locations) |
| Status | Recruiting |
| Started | May 19, 2025 |
| Main results expected | November 30, 2027 |
| Study ends | August 30, 2028 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT06830798 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with dialysis-dependent end-stage kidney disease who are undergoing kidney transplantation from high-risk donors.
✕Probably not a fit
Patients receiving kidneys from donors classified as category I, II, IV, and V or those with acute kidney injury of stage 3 severity may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the efficacy and safety of ravulizumab in adult kidney transplant recipients who are at high risk for delayed graft function (DGF). Participants will be randomly assigned to receive either ravulizumab or a placebo intravenously. The primary goal is to measure the time to freedom from dialysis, indicating the severity of DGF. This multicenter approach allows for a diverse patient population and robust data collection.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of delayed graft function in kidney transplant patients, improving their recovery and overall outcomes.
How similar studies have gone: Previous studies have shown promise in using monoclonal antibodies for similar conditions, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Phoenix, Arizona, United States Recruiting -
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Jacksonville, Florida, United States Recruiting
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São José do Rio Preto, Brazil Recruiting
+80 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Alexion Pharmaceuticals, Inc. (Sponsor)
- Email: clinicaltrials@alexion.com
- Phone: 1-855-752-2356
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Omnisol-preserved kidneys before transplant (hypothermic machine perfusion)
This study tests whether using Omnisol during hypothermic machine perfusion before kidney transplant can improve early graft function compared with standard preservation.
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How Propofol and Sevoflurane Affect miRNA in Living Kidney Donors
This study tests whether using propofol or sevoflurane during donor nephrectomy changes levels of miRNAs in living kidney donors.
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Intraoperative diuretics during deceased-donor kidney transplants
This trial tests whether using furosemide or mannitol during kidney transplant surgery affects delayed graft function in adults receiving a deceased-donor kidney.
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Effects of general vs spinal-epidural anesthesia on kidney transplant biomarkers
This study tests whether sevoflurane general anesthesia or combined spinal-epidural anesthesia changes markers of cellular stress and protective peptides in adults undergoing kidney transplantation.
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How kidney transplant patients feel about using artificial intelligence in medicine
This international survey asks adults who have had a kidney transplant how they feel about AI tools that predict graft loss and what it might mean for their daily care.
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Ravulizumab for Generalized Myasthenia Gravis in Chinese Adults
This trial tests ravulizumab in Chinese adults with generalized myasthenia gravis to see if it helps symptoms while checking safety and how the drug behaves in the body.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.