Long-term graft survival Surgery Graft survival
Conditions
Interventions
Intervention: ultrasound-guided protocol biopsy 3 and/or 12 months after kidney transplantation. Based on the histology, appropriate treatment:
1. Steroid intravenous (i.v.) bolus
2. CNI dose reducti
treated based on clinical symptoms (if any occur).
10 years follow-up is planned, analysing data annually.
Sponsors
University of Szeged (Hungary)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients (aged greater than 18 years), either sex 2. Receiving kidney transplant 3. A stable graft function (serum creatinine less than 300 µmol/l) three months after transplantation 4. No clinical symptoms or rejection for two months 5. Taking calcineurin-inhibitor (CNI) and mycophenolate mofetil (MMF) combination immunosuppressive therapy 6. A stable immunosuppressive drug trough level (tacrolimus [Tac] 5 - 15 ng/ml, cyclosporin [CsA] 100 - 250 ng/ml) 7. Signed informed consent, good compliance
Exclusion criteria
Exclusion criteria: 1. Rejection episode in the last two months 2. Taking anticoagulation therapy 3. Active infection
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Proteinuria 2. Serum glucose 3. Total cholesterol 4. High density lipoprotein (HDL) cholesterol 5. Low density lipoprotein (LDL) cholesterol 6. Triglyceride 7. Blood pressure 8. Cardiovascular events (number of events) Time points: Baseline, 3 months after transplantation, then monthly until 12 months, then every 3 months until 10 years or graft loss. | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Renal function measured by the serum creatinine and the estimated glomerular filtration rate (GFR) 2. Graft survival 3. Renal lesions measured by the Banff score Time points: Baseline, 3 months after transplantation, then monthly until 12 months, then every 3 months until 10 years or graft loss. | — |
Countries
Hungary
Outcome results
None listed