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Study on the Salvage Treatment of Chronic Antibody Mediated Rejection after Renal Transplantation with Telitacicept

Study on the Salvage Treatment of Chronic Antibody Mediated Rejection after Renal Transplantation with Telitacicept

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080182
Enrollment
Unknown
Registered
2024-01-23
Start date
2024-02-15
Completion date
Unknown
Last updated
2024-01-28

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

Conditions

cAMR

Interventions

Test group:Telitacicept

Sponsors

Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. CAMR was diagnosed by pathological biopsy; 2. Having undergone at least one round of routine anti rejection therapy (hormone shock+IVIG ± rituximab); During the follow-up process, the patient experienced symptoms such as unstable creatinine (increased by over 30%) and worsening proteinuria; Clinical considerations or needle biopsy confirm the persistent or progressive progression of cAMR lesions. 3. The patient voluntarily signs an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled infected patients; 2. Individuals who are known to be allergic to the study drug; 3. Pregnant or recently preparing pregnant women, lactating women; 4. Patients who are currently suffering from active hepatitis or have had a history of severe liver disease or illness; 5. Patients with active or recurrent gastrointestinal ulcers; 6. Subjects participating in clinical research on other drugs; In addition to the above, the researchers have determined that there are other reasons that are not suitable for participating in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Changes in urine protein and eGFR from baseline at week 24;

Secondary

MeasureTime frame
Changes in DSA levels and renal pathology scores from baseline at week 24;Changes in renal pathological score from baseline at 24 weeks;

Countries

china

Contacts

Public ContactDing Xiang

Xiangya Hospital of Central South University

xiangding@csu.edu.cn+86 135 4964 8789

Outcome results

None listed

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