Renal Transplant
Conditions
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 intravenous immunoglobulin (IVIG)/rituximab regimens versus rituximab alone.
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 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.
Interventions
DRUGRituximab
IV rituximab
iv intravenous immune globulin
Sponsors
Severance Hospital
GC Biopharma Corp
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients have de novo production of DR or DQ DSA after renal transplantation Inclusion criteria requires all of the following 1. age ≥ 19 years 2. Renal transplants with eGFR ≥ 20 ml/min (by CKD-EPI equation) and change in the eGFR ≤ 20 within 3 months 3. No history of biopsy proven acute T cell mediated rejection or antibody-mediated rejection within 3 months 4. peak MFI of de novo DSA (DR or DQ) ≥ 1000 5. A patient who agree to write a written consent form
Exclusion criteria
1. age ≤ 18 years 2. multi-organ transplantation 3. Patients with no history of tacrolimus as immunosuppressants 4. history of allergic or anaphylactic reaction to rituximab 5. human immunodeficiency virus infection 6. active infection 7. pregnancy or lactation 8. history of drug abuse or alcohol abuse within 6 months 9. history of malignancy within 5 years 10. history of treatment for psychiatric problems 11. hematologic or biochemical abnormalities (Hb \< 7g/dL, Platelet \< 1x105/mm3, AST/ALT \> 80IU) 12. A patient who do not want to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in delta DSA MFI sum | baseline and 3 months post-treatment, 1 year post-treatment | change of pre- and post-treatment DSA MFI sum, monitoring DSA during follow-up period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in estimated glomerular filtration rate(eGFR) by CKD-EPI equation | baseline and 3 months post-treatment, 1 year post-treatment | change of pre- and post-treatment eGFR by CKD-EPI equation, monitoring eGFR during follow-up period |
| Development of antibody-mediated rejection (AMR) | up to 1 year post-treatment | To identify the development of AMR after treatment during follow-up period |
Countries
South Korea
Outcome results
None listed