Clinical Trials List
2024-12-16 - 2029-12-31
Phase III
Recruiting4
ICD-10D89.810
Acute graft-versus-host disease
ICD-10D89.811
Chronic graft-versus-host disease
ICD-10D89.812
Acute on chronic graft-versus-host disease
ICD-10D89.813
Graft-versus-host disease, unspecified
ICD-10T86.10
Unspecified complication of kidney transplant
ICD-10T86.11
Kidney transplant rejection
ICD-10T86.12
Kidney transplant failure
ICD-10T86.13
Kidney transplant infection
ICD-10T86.19
Other complication of kidney transplant
ICD-9996.81
Complications of transplanted kidney
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
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Trial Applicant
台灣喜帝諮詢顧問有限公司
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Sponsor
台灣喜帝諮詢顧問有限公司
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Ya-Chung Tian Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 柳易揚 Division of Urology
- Wen-Chin Lee Division of Nephrology
- 沈元琦 Division of Urology
- 鄭偉權 Division of Urology
- 陳德全 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- MING-CHE LIU Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
post-transplant as defined in Section 9.3.1.1.
Inclution Criteria
Age
1. ≥ 18 years of age at the time of signing the informed consent.
Type of Participant and Disease Characteristics
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.
Weight
5. Body weight of ≥ 30 kg.
Sex and Contraceptive/Barrier Requirements
6. Male or female
7. Agrees to follow protocol-specified contraception guidance as outlined in Section 10.6.
Informed Consent
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.
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 < 0.3 mL/kg/hour for ≥ 24 hours OR anuria for ≥ 12 hours)
3. Recent use of immunosuppressants (eg, calcineurin, CD38 mAb, CD20, IL-6/IL-6R,
mTOR inhibitors) < 3 months prior to Screening Visit.
• Note: immunosuppressants allowed during the study are described in Section 6.9.1.
4. Is to receive a kidney from donors supported by extracorporeal membrane oxygenation.
5. Is to receive a machine-perfused donor kidney.
6. Is to receive a multiorgan transplant.
7. Is to receive kidney(s) from donors < 6 years of age.
8. Is to receive a dual kidney transplant (from same donor, including en bloc).
9. Is to receive a living donor kidney.
10. Is to receive a kidney with estimated (at time of randomization) > 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.
The Estimated Number of Participants
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Taiwan
10 participants
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Global
450 participants
