Kidney allograft protocol biopsy program
Not Applicable
Completed
- Conditions
- ong-term graft survivalSurgeryGraft survival
- Registration Number
- ISRCTN42131433
- Lead Sponsor
- niversity of Szeged (Hungary)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
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
1. Rejection episode in the last two months
2. Taking anticoagulation therapy
3. Active infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Renal function measured by the serum creatinine and the estimated glomerular filtration rate (GFR)<br>2. Graft survival<br>3. Renal lesions measured by the Banff score<br><br>Time points: <br>Baseline, 3 months after transplantation, then monthly until 12 months, then every 3 months until 10 years or graft loss.
- Secondary Outcome Measures
Name Time Method 1. Proteinuria<br>2. Serum glucose<br>3. Total cholesterol<br>4. High density lipoprotein (HDL) cholesterol<br>5. Low density lipoprotein (LDL) cholesterol <br>6. Triglyceride<br>7. Blood pressure<br>8. Cardiovascular events (number of events)<br><br>Time points: <br>Baseline, 3 months after transplantation, then monthly until 12 months, then every 3 months until 10 years or graft loss.