Delayed Graft FunctionPhase 3AWAKENCT06830798
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
A Phase 3 study testing Ravulizumab in people with Delayed Graft Function and DGF, run by Alexion Pharmaceuticals, Inc. at 130 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Graft Function, DGF, Kidney Transplant
- What is being tested?
- Ravulizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 130 sitesin 18 countries
- Study dates
- 19 May 2025to 30 Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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 locations and contacts
130 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
130 sites in 18 countries
United States32 sites, 30 recruiting
- Recruiting
Research Site
Ann Arbor, Michigan, 48109
- Recruiting
Research Site
Atlanta, Georgia, 30322
- Recruiting
Research Site
Charlottesville, Virginia, 22908
- Recruiting
Research Site
Chicago, Illinois, 60608
- Recruiting
Research Site
Chicago, Illinois, 60637
- Recruiting
Research Site
Dallas, Texas, 75235
- Recruiting
Research Site
Detroit, Michigan, 48202
- Recruiting
Research Site
Durham, North Carolina, 27705
- Recruiting
Research Site
Fairway, Kansas, 66205
- Recruiting
Research Site
Greenville, South Carolina, 29605
- Recruiting
Research Site
Houston, Texas, 77030
- Recruiting
Research Site
Jacksonville, Florida, 32224
- Recruiting
Research Site
Kenner, Louisiana, 70065
- Recruiting
Research Site
Lexington, Kentucky, 40508
- Recruiting
Research Site
Livingston, New Jersey, 07039
- Recruiting
Research Site
Los Angeles, California, 90095
- Recruiting
Research Site
Milwaukee, Wisconsin, 53226
- Recruiting
Research Site
Minneapolis, Minnesota, 55455
- Recruiting
Research Site
Nashville, Tennessee, 37232
- Recruiting
Research Site
New Haven, Connecticut, 06510
- Withdrawn
Research Site
New York, New York, 10016
- Recruiting
Research Site
New York, New York, 10065
- Recruiting
Research Site
Omaha, Nebraska, 68198
- Recruiting
Research Site
Philadelphia, Pennsylvania, 19140
- Recruiting
Research Site
Phoenix, Arizona, 85054
- Recruiting
Research Site
Richmond, Virginia, 23298
- Withdrawn
Research Site
San Francisco, California, 94115
- Recruiting
Research Site
San Francisco, California, 94143
- Recruiting
Research Site
Seattle, Washington, 98104
- Recruiting
Research Site
St Louis, Missouri, 63108
- Recruiting
Research Site
Stanford, California, 94305
- Recruiting
Research Site
Tampa, Florida, 33606
Spain15 sites, 15 recruiting
- Recruiting
Research Site
Badajoz, 06080
- Recruiting
Research Site
Barakaldo, 48903
- Recruiting
Research Site
Barcelona, 08025
- Recruiting
Research Site
Barcelona, 08035
- Recruiting
Research Site
Barcelona, 08036
- Recruiting
Research Site
Barcelona, 08907
- Recruiting
Research Site
Barcelona, 8003
- Recruiting
Research Site
Cadiz, 11009
- Recruiting
Research Site
Córdoba, 14004
- Recruiting
Research Site
Granada, 18014
- Recruiting
Research Site
Madrid, 28041
- Recruiting
Research Site
Málaga, 29010
- Recruiting
Research Site
Valencia, 46009
- Recruiting
Research Site
Valencia, 46017
- Recruiting
Research Site
Zaragoza, 50009
Brazil12 sites, 11 recruiting
- Recruiting
Research Site
Belo Horizonte, 30130-100
- Recruiting
Research Site
Belo Horizonte, 30150-221
- Withdrawn
Research Site
Botucatu, 18618-970
- Recruiting
Research Site
Botucatu, 18618-970
- Recruiting
Research Site
Campinas, 13083
- Recruiting
Research Site
Fortaleza, 60175295
- Recruiting
Research Site
Porto Alegre, 90035-903
- Recruiting
Research Site
Porto Alegre, 90050-170
- Recruiting
Research Site
Recife, 50070-550
- Recruiting
Research Site
Rio de Janeiro, 1033
- Recruiting
Research Site
São José do Rio Preto, 15090-000
- Recruiting
Research Site
São Paulo, 04036-002
China11 sites, 10 recruiting
- Recruiting
Research Site
Guangzhou, 510080
- Recruiting
Research Site
Guangzhou, 510260
- Recruiting
Research Site
Guangzhou, 510280
- Recruiting
Research Site
Hangzhou, 310015
- Recruiting
Research Site
Hengyang, 441021
- Recruiting
Research Site
Nanning, 530007
- Recruiting
Research Site
Shenzhen, 518020
- Withdrawn
Research Site
Taiyuan, 030032
- Recruiting
Research Site
Taiyuan, 030032
- Recruiting
Research Site
Tianjin, 300192
- Recruiting
Research Site
Zhengzhou, 450003
France7 sites, 2 recruiting
- Withdrawn
Research Site
Créteil, 94000
- Withdrawn
Research Site
La Rochelle, 17019
- Withdrawn
Research Site
La Tronche, 38700
- Not yet recruiting
Research Site
Montpellier, 34295
- Withdrawn
Research Site
Nantes, 44093
- Withdrawn
Research Site
Paris, 75651
- Not yet recruiting
Research Site
Toulouse, 31059
Italy6 sites, 6 recruiting
- Recruiting
Research Site
Bologna, 40138
- Recruiting
Research Site
Milan, 20122
- Recruiting
Research Site
Milan, 20162
- Recruiting
Research Site
Padova, 35128
- Recruiting
Research Site
Parma, 43100
- Recruiting
Research Site
Torino, 10126
Argentina5 sites, 5 recruiting
- Recruiting
Research Site
Buenos Aires, 1425
- Recruiting
Research Site
Buenos Aires, B1629AHJ
- Recruiting
Research Site
Buenos Aires, C1431FWO
- Not yet recruiting
Research Site
Capital Federal, C1155ADP
- Recruiting
Research Site
Córdoba, X5016LIG
Canada5 sites, 5 recruiting
- Recruiting
Research Site
Edmonton, Alberta, T6G 2E1
- Not yet recruiting
Research Site
Montreal, Quebec, H3T 1E2
- Recruiting
Research Site
Toronto, Ontario, M5B 1W8
- Not yet recruiting
Research Site
Toronto, Ontario, M5G 2C4
- Recruiting
Research Site
Vancouver, British Columbia, V5Z 1M9
Germany5 sites, 5 recruiting
- Recruiting
Research Site
Berlin, 10117
- Recruiting
Research Site
Erlangen, 91054
- Recruiting
Research Site
Lübeck, 23538
- Recruiting
Research Site
Mainz Am Rhein, 55131
- Recruiting
Research Site
Münster, 48149
Portugal5 sites, 5 recruiting
- Recruiting
Research Site
Lisbon, 1069-166
- Recruiting
Research Site
Lisbon, 1499-005
- Recruiting
Research Site
Lisbon, 1649-035
- Recruiting
Research Site
Porto, 4050-313
- Recruiting
Research Site
Porto, 4200319
United Kingdom5 sites, 5 recruiting
- Recruiting
Research Site
Leeds, LS9 7TF
- Recruiting
Research Site
London, E1 1BB
- Recruiting
Research Site
London, NW3 2QG
- Recruiting
Research Site
London, SE1 9RT
- Recruiting
Research Site
Woodville South, 5011
Australia4 sites, 4 recruiting
- Recruiting
Research Site
Adelaide, 5000
- Recruiting
Research Site
Brisbane, 4102
- Recruiting
Research Site
Camperdown, 2050
- Recruiting
Research Site
Murdoch, 6150
Poland4 sites, 3 recruiting
- Withdrawn
Research Site
Bydgoszcz, 85-094
- Recruiting
Research Site
Gdansk, 80-214
- Recruiting
Research Site
Poznan, 60-355
- Not yet recruiting
Research Site
Warsaw, 02-091
Taiwan4 sites, 4 recruiting
- Recruiting
Research Site
Kaohsiung City, 833
- Recruiting
Research Site
Taichung, 40447
- Recruiting
Research Site
Taipei, 110
- Not yet recruiting
Research Site
Taoyuan, 333
Czechia3 sites, 3 recruiting
- Recruiting
Research Site
Hradec Kralova, 50005
- Recruiting
Research Site
Ostrava, 708 52
- Recruiting
Research Site
Prague, 140 21
South Korea3 sites, 3 recruiting
- Recruiting
Research Site
Gyeonggi-do, 13620
- Recruiting
Research Site
Seoul, 03080
- Recruiting
Research Site
Seoul, 03722
Austria2 sites, 2 recruiting
- Recruiting
Research Site
Innsbruck, 6020
- Recruiting
Research Site
Vienna, 1090
Japan2 sites, 2 recruiting
- Recruiting
Research Site
Kyoto, 602-8566
- Recruiting
Research Site
Suita-shi, 565-0871
About this study
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
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.
Read the detailed description
AWAKE is a multicenter, prospective study to evaluate the safety and efficacy of ravulizumab in reducing delayed graft function (DGF) in kidney transplant recipients at high risk for DGF. Eligible participants will be randomized in a 1:1 ratio to receive either ravulizumab or placebo intravenously.
- Conditions
- Delayed Graft Function, DGF, Kidney Transplant
- Being tested
- Ravulizumab, Placebo
- Keywords
- Delayed Graft Function, DGF, Kidney Transplant, Ravulizumab
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RavulizumabDrug
Participants will receive ravulizumab via intravenous (IV) infusion.
PlaceboDrug
Participants will receive placebo via intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Ravulizumab | Experimental | Participants will receive an IV dose of ravulizumab. Receives: Drug: Ravulizumab |
| Placebo | Placebo comparator | Participants will receive an IV dose of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Freedom from Dialysis
Measured: Through 90 days post-transplant
Secondary outcomes (3)
DGF Incidence
Measured: Up to 7 days post-transplant
Number of Dialysis Sessions
Measured: Through 90 days post-transplant
Time to Occurrence of eGFR reaching 30 mL/min/1.73 m2
Measured: Through 90 days post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start19 May 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Graft FunctionStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830798
- Sponsor's protocol ID
- D928EC00001
- Other IDs
- 2024-517568-48
- Acronym
- AWAKE
- Status last verified
- Jun 2026
- First submitted
- 10 Feb 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06830798
- Acronym / sponsor ID
- AWAKE / D928EC00001
- Conditions
- Delayed Graft Function, DGF, Kidney Transplant
- Keywords
- Delayed Graft Function, DGF, Kidney Transplant, Ravulizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 May 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
AWAKE is a multicenter, prospective study to evaluate the safety and efficacy of ravulizumab in reducing delayed graft function (DGF) in kidney transplant recipients at high risk for DGF. Eligible participants will be randomized in a 1:1 ratio to receive either ravulizumab or placebo intravenously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ravulizumab | Experimental | Drug: RavulizumabParticipants will receive an IV dose of ravulizumab. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive an IV dose of placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RavulizumabParticipants will receive ravulizumab via intravenous (IV) infusion. | Drug | Ravulizumab |
| PlaceboParticipants will receive placebo via intravenous (IV) infusion. | Drug | Placebo |
Primary outcome
Time to Freedom from Dialysis
Time frame: Through 90 days post-transplant
3 secondary outcomes
DGF Incidence
Time frame: Up to 7 days post-transplant
Number of Dialysis Sessions
Time frame: Through 90 days post-transplant
Time to Occurrence of eGFR reaching 30 mL/min/1.73 m2
Time frame: Through 90 days post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes. Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Related trials for Delayed Graft Function
Enrolling by invitation
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
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Active, not recruitingPhase 2
ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
Delayed Graft Function
Not yet recruiting
Drone Transport of Deceased-Donor Kidney Grafts Between Two French Hospitals Before Transplantation: a Pilot Safety Study
Kidney Failure, Chronic, Kidney Transplantation
Recruiting
The Impact of Intraoperative Diuretic Use on Delayed Graft Function Following Deceased Donor Renal Transplantation
Delayed Graft Function, Kidney Transplantation
Not yet recruiting
TxAccess and Dd-cfDNA for Improved Care of Patients With Delayed Graft Function
Delayed Graft Function
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
130 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ravulizumab in people with Delayed Graft Function and DGF, run by Alexion Pharmaceuticals, Inc. at 130 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 130 sites in United States, Spain, Brazil, China, France and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexion Pharmaceuticals, Inc. (Sponsor) (1-855-752-2356, clinicaltrials@alexion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Freedom from Dialysis (time frame: Through 90 days post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.