Patients with transplanted kidney and stabilised graft function
Conditions
Interventions
Trade Name: SOLU-MEDROL inj.
Pharmaceutical Form:
INN or Proposed INN: methylprednisolon
Concentration unit: mg milligram(s)
Concentration type: range
Sponsors
Institute for clinical and experimental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Impact of antirejection treatment with Solu-Medrol on graft function development 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 | — |
Countries
Czech Republic
Outcome results
None listed