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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

ConditionsDelayed Graft FunctionDGFKidney Transplant
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexion Pharmaceuticals, Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years of age at the time of signing the informed consent

Diagnosed with Dialysis-dependent End-Stage Kidney Disease (ESKD)

Donation after Circulatory Death (DCD) donor

High-risk Donation after Brain Death (DBD) donor

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ravulizumab

    Drug

    Participants will receive ravulizumab via intravenous (IV) infusion.

  • Placebo

    Drug

    Participants will receive placebo via intravenous (IV) infusion.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: RavulizumabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to Freedom from Dialysis

Time frame
Through 90 days post-transplant

Secondary outcomes

1

DGF Incidence

Time frame
Up to 7 days post-transplant
2

Number of Dialysis Sessions

Time frame
Through 90 days post-transplant
3

Time to Occurrence of eGFR reaching 30 mL/min/1.73 m2

Time frame
Through 90 days post-transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexion Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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