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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Alexion Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

21 Jul 2025 → ongoing

Decision date (initial)

2025-06-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Alexion Pharmaceuticals Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacodynamic, Efficacy, Pharmacokinetic

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

Secondary objectives 3

1. To assess the effect of ravulizumab vs placebo on DGF incidence in adult participants who are at high risk of DGF after undergoing transplant of deceased donor kidney
2. To assess the effect of ravulizumab vs placebo on dialysis utilization in adult participants who are at high risk of DGF after undergoing transplant of deceased donor kidney
3. To assess graft function in renal transplant recipients treated with ravulizumab vs placebo in adult participants who are at high risk of DGF after undergoing transplant of deceased donor kidney

Conditions and MedDRA coding

Delayed Graft Function after Kidney Transplantation

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. ≥ 18 years of age at the time of signing the informed consent
2. Diagnosed with dialysis-dependent End-Stage Kidney Disease (ESKD)
3. A candidate for kidney transplant from: a) Donation after Circulatory Death (DCD) donor; b) High-risk Donation after Brain Death (DBD) donor

Exclusion criteria 2

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time to freedom from dialysis through 90 days post-transplant

Secondary endpoints 3

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Alexion Pharmaceuticals Inc.

Sponsor organisation

Alexion Pharmaceuticals Inc.

Address

121 Seaport Boulevard

City

Boston

Postcode

02210-2050

Country

United States

Scientific contact point

Organisation

Alexion Pharmaceuticals Inc.

Contact name

Aurelie Broch d'Hotelans

Public contact point

Organisation

Alexion Pharmaceuticals Inc.

Contact name

Aurelie Broch d'Hotelans

Third parties 12

Locations

8 EU/EEA countries · 42 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 126 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications