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Tests treatment safety and results for Delayed Graft Function
Official title 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
ClinicalTrials.gov ID: NCT06830798
What this study is testing
What is Ravulizumab?
Ravulizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for delayed graft function.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 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:
- Donation after Circulatory Death (DCD) donor
- High-risk Donation after Brain Death (DBD) donor
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Fairway, Kansas, United States
- Lexington, Kentucky, United States
- Kenner, Louisiana, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Livingston, New Jersey, United States
- New York, New York, United States
- Durham, North Carolina, United States
+ 86 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; San Francisco, California, United States; Stanford, California, United States; New Haven, Connecticut, United States; Jacksonville, Florida, United States and 100 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.