Randomized, open, controlled trial for comparison of combination therapy of high-dose IVIG and rituximab and rituximab in kidney transplant patients with de novo donor-specific antibodies
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0003923
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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