None listed
Conditions
Interventions
Drug : Patients are randomly assigned to rituximab only or combination of rituximab/IVIG: (1) rituximab only regimen will consist of 25 patients, treated with 375mg/m2 rituximab at day 0
(2) combination of rituximab/IVIG regimen will consist of 25 patients, treated with rituximab (375mg/m2) and high-dose IVIG(2g/kg) at day 0
[intravenous immunoglobulin]
1. Administration
- initial in
if symptoms subside promptly, may resume infusion at a lower rate
2. Total dose: 2g/kg
3. Route: intravenous infusion
4. Frequency: a single dose
5. Duration: 1 day
[Rituximab]
1. Administration
- Ad
in the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to maximum of 400 mg/hr
- Subsequent infusion: Initiate infusion at a rate of 100 mg/hr
in the absence of infusion toxicity, increase rate by 100mg/hr increments at 30 minutes intervals, to maximum of 400 mg/hr
- Interrupt the infusion or slow the infusion rate for infusion reactions
2.
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients who have DSA in DR or DQ after renal transplantation are eligible. Inclusion criteria requires all of the following ? age = 19 years ? Patient 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 acute antibody-mediated rejection within 3 months ? DSA peak MFI in DR or DQ =1000 ? A patient who agree to write a written consent form
Exclusion criteria
Exclusion criteria: If any of the following criteria is included, they are excluded. ? age = 18 years ? multi-organ transplantation at the same time ? Patients with no history of tacrolimus as immunosuppressants ? history of allergic or anaphylactic reaction to rituximab ? human immunodeficiency virus infection ? active infection (Patients treated with infectious disease (including bacteria, fungi, viruses, and micobacterium tuberculosis) or patients who have received antibiotic treatment for injections within the last 4 weeks) ? 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 (major depression, bipolar disorder, schizophrenia, personality disorder, etc.) ? hematologic or biochemical abnormalities (Hb < 7g/dL, Platelet < 0.5x10^5/mm3, AST/ALT > 80IU) ? A patient who do not want to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delta DSA(Donor Specific Antibody) MFI (Median Fluorescence Intensity) sum after 3 months of treatment : change of pre- and post-treatment DSA MFI sum( The difference between the mean values of the delta DSA MFI values between the two groups is checked to be greater than zero) | — |
Secondary
| Measure | Time frame |
|---|---|
| DSA(Donor Specific Antibody) MFI (Median Fluorescence Intensity) after 1 year of treatment(Changes of DSA during follow-up evaluation), Change of estimated glomerular filtration rate by CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation after 3 months & 1 year of treatment, Ocurrence of Antibody-mediated rejection during follow up observation | — |
Countries
Korea, Republic of
Contacts
Public ContactTaiyeon Koo
Seoul National University Hospital
Outcome results
None listed