Comparing high dose and low dose Rituximab in the treatment of rejection in kidney transplant recipients
- Conditions
- Antibody-mediated rejection in kidney transplant recipients.Kidney transplant status
- Registration Number
- IRCT201508103043N10
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
1. Kidney transplant recipients recieve immunosuppression regimen including Thymoglobulin+Tacrolimus+Mycophenolate+ Prednisolone
2. Strong clinical suspicious of antibody-mediated acute rejection (AMR) (sudden impairment in function of the graft including anuria and increasing serum creatinine after a few days of having functional kidney) or definite diagnosis of AMR (morphologic and immunopathologic evidences of AMR in a biopsy specimen of the graft) or measuring serum DSA (Donor-specific antibody) levels.
Exclusion criteria:
1. The patient's preference not to proceed the treatment
2. Evidence of definite diagnosis other than AMR in Pathologic report
3. Serious side effects associated to the medications used in this trial
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recipient serum Creatinine. Timepoint: Daily during hospitalization, then weekly until the end of the first month after transplant, then monthly until the end of the third month after transplat. Method of measurement: Blood samples in laboratories in milligrams / deciliter (jaffe technique).;Recipient urine output. Timepoint: Before transplantation and daily during hospitalization. Method of measurement: Graduated container in ml/day.
- Secondary Outcome Measures
Name Time Method Complete blood count. Timepoint: Daily during hospitalization. Method of measurement: Laboratory.;Srum lactate dehydrogenase. Timepoint: Twice weekly during hospitalization. Method of measurement: Laboratory.;3-month Graft survival. Timepoint: Monthly follow-up. Method of measurement: Going back of recipient to dialysis.;3-month patient survival. Timepoint: Monthly follow-up. Method of measurement: Patient death or live.