Kidney TransplantationPhase 1/2NCT06453135
Eculizumab for Prevention of Antibody-Mediated Rejection in ABO-Incompatible Living Donor Kidney Transplantation
A Phase 1/2 study testing Eculizumab in people with Kidney Transplantation, run by Tao Lin at 1 site in China.
Trial summary
The aim of this study is to determine whether a single dose of eculizumab can effectively prevent antibody-mediated rejection in recipients undergoing living donor kidney transplantation with a different ABO blood group type than their donors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Eculizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jul 2024to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- aged ≥ 18 years, male or female
- Suffering from end-stage renal disease and planning for ABO blood group incompatible living donor kidney transplantation
- Vaccinated against Neisseria meningitides (quadrivalent vaccine), Pneumococcus or H. influenzae at least two weeks prior to using eculizumab
- Be able to understand the informed consent form and willing to comply with the protocol
Who cannot join
- Previous splenectomy
- Any active bacterial or other infection
- Known or suspected hereditary complement deficiency
- Known hypersensitivity to the treatment drug or any of its excipients
- History of Neisseria meningitidis
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
28 85582944 ext. +86
About this study
Official title: A Single Center, Open-label, Single-arm Study to Determine the Safety and Efficacy of a Single Dosing Regimen Eculizumab for Prevention of Antibody-Mediated Rejection (AMR) in ABO Blood Group Incompatible Living Donor Kidney Transplantation (ABOi-LDKTx)
The aim of this study is to determine whether a single dose of eculizumab can effectively prevent antibody-mediated rejection in recipients undergoing living donor kidney transplantation with a different ABO blood group type than their donors
Read the detailed description
Kidney transplantation is considered the best therapy for patients with end-stage renal disease. ABO-incompatible living donor kidney transplantation (ABOi-LDKTx) is one of the strategies to expand the pool of donors. However, the blood group antibodies in recipients can lead to acute rejection, resulting in transplant failure. Before transplantation, the use of rituximab (RTX) to remove B cells; plasmapheresis to eliminate blood group antibodies can mitigate the occurrence of acute rejection and enhance the success rate of transplantation.
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
- Kidney Transplantation
- Being tested
- Eculizumab
- Keywords
- Kidney Transplantation, Eculizumab, Antibody-mediated rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EculizumabDrug
Also called Soliris
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.
| Study group | Role | What they receive |
|---|---|---|
| Eculizumab | Experimental | A single dose of eculizumab was given on the Day 0 before the transplant surgery. Receives: Drug: Eculizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of AMR within 6 months after transplantation
Measured: 6 months after kidney transplant surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao Lin, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453135
- Sponsor's protocol ID
- WestChina-ECU-KT
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label, Single-arm Study to Determine the Safety and Efficacy of a Single Dosing Regimen Eculizumab for Prevention of Antibody-Mediated Rejection (AMR) in ABO Blood Group Incompatible Living Donor Kidney Transplantation (ABOi-LDKTx)
- ClinicalTrials.gov ID
- NCT06453135
- Acronym / sponsor ID
- WestChina-ECU-KT
- Conditions
- Kidney Transplantation
- Keywords
- Kidney Transplantation, Eculizumab, Antibody-mediated rejection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tao LinUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Jun 2024 (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 aim of this study is to determine whether a single dose of eculizumab can effectively prevent antibody-mediated rejection in recipients undergoing living donor kidney transplantation with a different ABO blood group type than their donors
Detailed description
Kidney transplantation is considered the best therapy for patients with end-stage renal disease. ABO-incompatible living donor kidney transplantation (ABOi-LDKTx) is one of the strategies to expand the pool of donors. However, the blood group antibodies in recipients can lead to acute rejection, resulting in transplant failure. Before transplantation, the use of rituximab (RTX) to remove B cells; plasmapheresis to eliminate blood group antibodies can mitigate the occurrence of acute rejection and enhance the success rate of transplantation.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eculizumab | Experimental | Drug: EculizumabA single dose of eculizumab was given on the Day 0 before the transplant surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged ≥ 18 years, male or female
- Suffering from end-stage renal disease and planning for ABO blood group incompatible living donor kidney transplantation
- Vaccinated against Neisseria meningitides (quadrivalent vaccine), Pneumococcus or H. influenzae at least two weeks prior to using eculizumab
- Be able to understand the informed consent form and willing to comply with the protocol
Key exclusion criteria (6 listed)
- Previous splenectomy
- Any active bacterial or other infection
- Known or suspected hereditary complement deficiency
- Known hypersensitivity to the treatment drug or any of its excipients
- History of Neisseria meningitidis
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 |
|---|---|---|
| EculizumabAlso: SolirisOn 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. | Drug | Eculizumab |
Primary outcome
The incidence of AMR within 6 months after transplantation
Time frame: 6 months after kidney transplant surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Eculizumab in people with Kidney Transplantation, run by Tao Lin at 1 site in China.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Lin, M.D. (18980602093 ext. +86, dr_taolin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of AMR within 6 months after transplantation (time frame: 6 months after kidney transplant surgery). 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 13 Jun 2024.