Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Severance Hospital | OTHER |
| GC Biopharma Corp | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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 intravenous immunoglobulin (IVIG)/rituximab regimens versus rituximab alone.
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 outcomes, long-term allograft loss attributable to AMR is still responsible for substantial medical and socioeconomic burdens in kidney transplant recipients. Numerous studies have shown that de novo DSA after KT are associated with AMR, which leads to allograft loss. IVIG is a medication that has emerged as a useful tool in modulating immunity, treatment of AMR and in desensitization protocol. Treatment with rituximab or combination of IVIG/rituximab has sought to further diminish antibody production (de novo DSA) in the treatment of AMR. Several studies have been reported, but in the absence of control groups or standardization of treatment, their efficacy is difficult to assess.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Active Comparator | Inj Rituximab 375mg/m2 IV given on day 0 |
|
| Combination of high-dose IVIG and Rituximab | Active Comparator | IV Rituximab 375mg/m2 on day 0 and IV high-dose IVIG 2g/kg on day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | IV rituximab |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in delta DSA MFI sum | change of pre- and post-treatment DSA MFI sum, monitoring DSA during follow-up period | baseline and 3 months post-treatment, 1 year post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in estimated glomerular filtration rate(eGFR) by CKD-EPI equation | change of pre- and post-treatment eGFR by CKD-EPI equation, monitoring eGFR during follow-up period | baseline and 3 months post-treatment, 1 year post-treatment |
| Development of antibody-mediated rejection (AMR) |
Not provided
Inclusion Criteria:
All patients have de novo production of DR or DQ DSA after renal transplantation Inclusion criteria requires all of the following
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jaeseok Yang, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea | |||
| Severance Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37169835 | Derived | Kim HW, Lee J, Heo SJ, Kim BS, Huh KH, Yang J. Comparison of high-dose IVIG and rituximab versus rituximab as a preemptive therapy for de novo donor-specific antibodies in kidney transplant patients. Sci Rep. 2023 May 11;13(1):7682. doi: 10.1038/s41598-023-34804-6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| intravenous immune globulin | Drug | iv intravenous immune globulin |
|
|
To identify the development of AMR after treatment during follow-up period |
| up to 1 year post-treatment |
| Seoul |
| 03722 |
| South Korea |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |