Delayed Graft Function after Kidney Transplantation
Conditions
Interventions
ravulizumab:ravulizumab
placebo:placebo
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. >= 18 years of age at the time of signing the informed consent. 2. Diagnosed with dialysis-dependent ESKD; 3. A candidate for kidney transplant from 1 of the following: a. DCD donor; b. DBD donor with KDPI score of >= 60%; or c. DBD donor fulfilling the following criteria: - 41 to 50 years of age with 2 of the following conditions: history of DM, HTN, or CVA as cause of death - 51 to 60 years of age with either history of DM, HTN, or CVA as cause of death - Any DBD donor > 60 years of age; 4. Has undergone at least 1 year of dialysis (hemodialysis or peritoneal) treatment prior to enrollment. 5. Body weight of >= 30 kg. 6. Male or female; 7. Agrees to follow protocol-specified contraception guidance as outlined in Section 10.6. 8. Provides signed informed consent as described in Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICF and this protocol. 9. Willing to be vaccinated against N meningitidis and willing to receive prophylactic treatment with appropriate antibiotics, if needed, as described in Section 8.3.6. 10. Willing to receive hemodialysis for the first 90 days post-transplant. Participants receiving peritoneal dialysis prior to transplant must be willing to switch to hemodialysis for the first 90 days post-transplant. 1.Optional:11. Provision of signed and dated written Optional Genomics Initiative Research Information informed consent prior to collection of samples for optional Genomics Initiative research that supports the Genomic Initiative. Refer to Sections 8.10 and 10.8.
Exclusion criteria
Exclusion criteria: 1. Is to receive a kidney from a donor with the following Maastricht classification (Sánchez-Fructuoso, 2000): a. Category I: Dead on arrival at hospital. b. Category II: Unsuccessful resuscitation. c. Category IV: Unexpected cardiac arrest after brain death. d. Category V: Unexpected cardiac arrest in intensive care. 2. Is to receive a kidney from a donor known of having had either of the following: a. AKI KDIGO Stage 3 (defined as creatinine 3.0 times baseline OR increase in sCr to >= 4.0 mg/dL [>= 353.6 µmol/L]) b. Urine output = 24 hours OR anuria for >= 12 hours); 3. Recent use of immunosuppressants (eg, calcineurin, CD38 mAb, CD20, IL-6/IL-6R, mTOR inhibitors) 24 hours of cold ischemia time. 11. Highly sensitized (high risk to develop acute AMR) to the donor, as indicated by PRA level >= 98%. • Note: median fluorescence intensity threshold and timing will be determined by the local practice. Testing to determine high risk may include, but is not limited to, flow cytometric crossmatch. 12. Will be the recipient of an ABO incompatible kidney (A2 donors to B and O recipients will be allowed if the site has the ability to confirm A2 subtype). 13. Is to receive a kidney from donors with a known history or positive serology of HBV or HCV infection (including successfully treated participants with positive HCV antibody and negative HCV RNA test). 14. Known or suspected complement-mediated disease (including, but not limited to, aHUS or PNH). 15. Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization. 16. Known history of HIV who are not on anti-retroviral therapy or if on therapy have a known detectable viral load within 1 year of Screening. 17. Known history or positive serology of HBV or HCV infection within 3 months prior to study intervention including successfully treated participants with positive HCV antibody and negative HCV RNA test; 18. Congenital immunodeficiency. 19. History of unexplained, recurrent infection. 20. Known medical or psychological condition(s), including substance abuse, or risk factor that, in the opinion of the Investigator, might interfere with the participant’s full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study. 21. History of, or unresolved, N meningitidis infection. 22. Hypersensitivity to any ingredient contained in the study intervention, including hypersensitivity to murine proteins. 23. Current malignancy or receiving treatment for malignancy except for non-melanoma skin cancer. 24. Prior use of any complement inhibitors within 5 half-lives (if known) or 6 months before initiation of the study intervention, whichever is longer, or planned use during the course of the study. 25. Participation in another investigational drug study within 5 half-lives (if known) or 30 days before initiation of the study int
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to freedom from dialysis through 90 days post-transplant.; | — |
Countries
China
Contacts
Public ContactChangxi Wang
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed