Status:
COMPLETED
IVIG/Rituximab vs Rituximab in Kidney Transplant With de Novo Donor-specific Antibodies
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Severance Hospital
GC Biopharma Corp
Conditions:
Renal Transplant
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The objective of this study was to compare two strategies of de novo donor specific antibodies (DSA) and antibody-mediated rejection (AMR) prevention in renal transplant recipients: high dose intraven...
Detailed Description
Although recent advances in immunosuppressive regimens after kidney transplantation (KT) have reduced the incidence and consequences of T-cell-mediated rejection (TCMR) and have improved short-term ou...
Eligibility Criteria
Inclusion
- All patients have de novo production of DR or DQ DSA after renal transplantation Inclusion criteria requires all of the following
- age ≥ 19 years
- Renal transplants with eGFR ≥ 20 ml/min (by CKD-EPI equation) and change in the eGFR ≤ 20 within 3 months
- No history of biopsy proven acute T cell mediated rejection or antibody-mediated rejection within 3 months
- peak MFI of de novo DSA (DR or DQ) ≥ 1000
- A patient who agree to write a written consent form
Exclusion
- age ≤ 18 years
- multi-organ transplantation
- Patients with no history of tacrolimus as immunosuppressants
- history of allergic or anaphylactic reaction to rituximab
- human immunodeficiency virus infection
- active infection
- pregnancy or lactation
- history of drug abuse or alcohol abuse within 6 months
- history of malignancy within 5 years
- history of treatment for psychiatric problems
- hematologic or biochemical abnormalities (Hb \< 7g/dL, Platelet \< 1x105/mm3, AST/ALT \> 80IU)
- A patient who do not want to participate in this study
Key Trial Info
Start Date :
January 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04033276
Start Date
January 8 2019
End Date
May 3 2022
Last Update
October 26 2022
Active Locations (2)
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1
Seoul National University Hospital
Seoul, South Korea, 03080
2
Severance Hospital
Seoul, South Korea, 03722