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A multi-center randomized controlled clinical study of multi-target synergistic treatment for chronic active antibody-mediated rejection

A multi-center randomized controlled clinical study of multi-target synergistic treatment for chronic active antibody-mediated rejection

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081077
Enrollment
Unknown
Registered
2024-02-21
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic active antibody-mediated rejection

Interventions

Plasma exchange/IVIg + rituximab:Patients were successfully screened with intravenous rituximab (100mg/m2), 4 plasmapheresis/IVIg sessions were started 3 days later, with an interval of one day betwee
Plasma exchange/IVIg + rituximab + tetaercept:Patients were successfully screened with intravenous infusion of rituximab (100mg/m2), 4 plasmapheresis/IVIg sessions were started 3 days later, with an i

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Signed, dated informed consent; (2) Promise to comply with the research procedures and cooperate with the implementation of the whole process of research; (3) Patients aged between 18 and 60 years after kidney transplantation; (4) Positive dnDSA of patients after kidney transplantation; (5) Transplanted kidney biopsy diagnosis of caAMR.

Exclusion criteria

Exclusion criteria: (1) Pregnant or lactating female patients; (2) the patient has any form of substance abuse, mental illness, or any condition that, in the opinion of the investigators, may interfere with the patient's understanding of the study requirements; (3) Patients who received another investigational drug within 30 days prior to enrollment; (4) Those who have contraindications to the use of mTORi, TAC, CsA and hormones; (5) Active peptic ulcer; (6) Patients with severe cardiopulmonary diseases; (7) Patients with active liver disease; (8) Patients with prior malignant tumors (except for successfully treated localized non-melanocytic skin cancer); (9) Patients who are unable to undergo routine study visits or follow-up, or patients who are followed up in non-certified laboratories.

Design outcomes

Primary

MeasureTime frame
dnDSA;absolute number of blood lymphocytes;urinary albumintocreatinine ratio;kidney function;Cytomegalovirus DNA load;BK virus DNA load;tacrolimus trough blood concentration;panel reactive antibody;HLA antibody;protocol biopsy;dd-cfDNA;adverse event;high resolution HLA matching of donor and recipient;

Secondary

MeasureTime frame
Physical examination;

Countries

China

Contacts

Public ContactXiaoming Ding

The First Affiliated Hospital of Xi'an Jiaotong University

xmding1970@126.vpm+86 139 9123 8632

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026