Treatment of borderline changesin protocol biopsy 3 months after renal transplantatio
- Conditions
- Patients with transplanted kidney and stabilised graft function
- Registration Number
- EUCTR2006-000607-42-CZ
- Lead Sponsor
- Institute for clinical and experimental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
a. 3 months after kidney transplantation
b. stabilised graft function with serum creatinine under 300 umol/l
c. borderline changes according to Banff classification in protocol biopsy
d. signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
a. Graft dysfunction due to rejection or to other reasons less than 1 month before biopsy
b. reduced graft function with serum creatinine 300 umol/l or higher
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Impact of antirejection treatment with Solu-Medrol on graft function development<br>in patients with borderline changes in 3-months protocol graft biopsy.;Secondary Objective: Impact of antirejection treatment with Solu-Medrol on acute rejection prevalence and graft survival in patients with borderline changes in 3-months protocol graft biopsy ;Primary end point(s): Graft function assessed by serum creatinine and glomerular filtration rate calculated by Cockroft-Gault formula and MDRD at 1 and 2 years posttransplant
- Secondary Outcome Measures
Name Time Method