Acute transplant rejection Signs and Symptoms Acute transplant rejection
Conditions
Interventions
Participants are randomly allocated to one of three groups.
Group 1: Participants are treated with a total of 4.5 mg/kg in 3 days, receiving 1.5 mg/kg in each days infused over 6 hours
Group 2: Part
Sponsors
Shahid Beheshti Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 years 2. Positive Panel Reactive Antibody (PRA) (> 0%) at the time of transplantation 3. History of previous transplantation 4. Extended criteria donor (ECD) 5. Cold ischemia time > 6 hours
Exclusion criteria
Exclusion criteria: 1. Multiple organ transplants 2. Serological evidence of human immunodeficiency virus or active hepatitis B and C in recipients or donors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate and severity of acute rejection during the first year post-transplantation is measured using kidney biopsy at 6 months post-transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to and the rate of serious infections are measured using history of admissions and blood culture and urine culture taken at each time admission for one year after transplantation 2. CMV infection rate is measured using CMV Ag pp65 antigenemia confirmed by CMV PCR monthly for one year after transpmantation 3. Length of hospital stay is measured through patient note review for any hospital admission within one year of transplantation 4. Rate of readmission is measured through patient note review for one year after transplantation 5. Incidence of hematologic abnormalities and renal function are assessed by measuring serum creatinine and estimating glomerular filtration rate using CKD-EPI using CKD-EPI and checking CBC (diff) monthly at each visit for one year after transplantation | — |
Countries
Iran
Outcome results
None listed