Antibody-mediated rejection in kidney transplant recipients. Kidney transplant status
Conditions
Interventions
Intervention 1: Control group (regimen currently being used in some Iranian transplant centers): Plasmapheresis+ IVIg+ high-dose Rituximab: Patients will receive 100mg/kg Of IVIg after each plasmapher
Treatment - Drugs
Control group (regimen currently being used in some Iranian transplant centers): Plasmapheresis+ IVIg+ high-dose Rituximab: Patients will receive 100mg/kg Of IVIg after each plasmapheresis session. 4
Intervention group: Plasmapheresis+ IVIg+ low-dose Rituximab: IVIg (100mg/kg) will be infused after each plasmaoheresis session.2 doses of Rituximab (375mg/m2) will be administered on a weekly basis.
Control group (regimen currently being used in some Iranian transplant centers): IVIg+ plasmapheresis. The patients will receive 300-400mg/kg of IVIg after each plasmapheresis session to the total cum
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh Ahmadi
Department of Clinical Pharmacy, Tehran University of Medical Sciences
Outcome results
None listed