Eculizumab for Prevention of Antibody-Mediated Rejection in ABO-Incompatible Living Donor Kidney Transplantation
NCT ID: NCT06453135
Last Updated: 2024-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2024-07-31
2025-12-31
Brief Summary
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Detailed Description
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The complement system plays a vital role in antibody-mediated rejection (AMR). Eculizumab can target the C5 protein of the complement system and then block the activation. Therefore, we hypothesize that the pretransplant use of eculizumab may prevent the AMR in ABOi-LDKTx.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Eculizumab
A single dose of eculizumab was given on the Day 0 before the transplant surgery.
Eculizumab
On the Day 0, participants received a single dose of eculizumab before the transplant surgery: 900 mg (blood type antibody titer ≥ 1:64 and/or body weight ≥ 60 kg) or 600 mg (blood type antibody titer \< 1:64 and body weight \< 60 kg). Plasmapheresis was not planned. When participants developed AMR, they may receive additional dose of eculizumab.
Interventions
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Eculizumab
On the Day 0, participants received a single dose of eculizumab before the transplant surgery: 900 mg (blood type antibody titer ≥ 1:64 and/or body weight ≥ 60 kg) or 600 mg (blood type antibody titer \< 1:64 and body weight \< 60 kg). Plasmapheresis was not planned. When participants developed AMR, they may receive additional dose of eculizumab.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Suffering from end-stage renal disease and planning for ABO blood group incompatible living donor kidney transplantation
3. Vaccinated against Neisseria meningitides (quadrivalent vaccine), Pneumococcus or H. influenzae at least two weeks prior to using eculizumab
4. Be able to understand the informed consent form and willing to comply with the protocol
Exclusion Criteria
2. Any active bacterial or other infection
3. Known or suspected hereditary complement deficiency
4. Known hypersensitivity to the treatment drug or any of its excipients
5. History of Neisseria meningitidis
6. Any health condition that the investigator believes may interfere with the patient's participation, pose additional risks to the patient, or confound with the patient's assessment (e.g. severe cardiovascular or pulmonary disease)
18 Years
ALL
No
Sponsors
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Tao Lin
OTHER
Responsible Party
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Tao Lin
Principal Investigator (PI)
Locations
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West China Hospital, Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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WestChina-ECU-KT
Identifier Type: -
Identifier Source: org_study_id
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