One year follow-up in patients after receiving renal transplantation
Conditions
Interventions
Trade Name: CellCept 500 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: MYCOPHENOLATE MOFETIL
CAS Number: 115007346
Concentration unit: mg milligram(s)
Trade Name: Simulect
Pharmaceutical Form:
Sponsors
University Hospital Freiburg, represented by the Executive Medical Director (LÄD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Post mortal kidney donation or living donation • Primary and secondary renal transplantation, unless the graft was lost due to severe rejection within the first year • PRA level =20%. • Recipient =18 - 75 years of age • AB0-compatibel • Negative crosshatch • Patients with a signed informed consent form • Women of child-bearing age must agree to an efficient contraception 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: • Third or multiple transplantation • Transplantation per a „non-heart beating“ donor • HLA-identical living donation • Incompatibility to study medication (allergy, intolerance, hypersensitivity) • Patients with existing malignant underlying disease or tumour anamnesis 30 hours • Pregnant or nursing patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ratio and severe of acute bioptical confirmed rejection reactions (to BANFF) as well as time to first bioptical assured rejection;Secondary Objective: - ratio on steroid-free immunsuppression - patient and graft survival - graft function (calculated GFR to MDRD-IV Formula or Cockgraft-Gault Formula or measured Creatinine Clearence after one year or Cystatine-C measure - number of steroid resistant rejection reactions - incidence of chronic allograft nephropathy (CAN) - level of bloodpressure and amount and description of antihypertension drugs - level of lipidvalues and amount and description of lipidreducing drugs - weight, relative gain in weight in kg; BMI - ratio of infections and forms of infections and severity of infections - anaemia with erythropoetin-needed-treatment - incidence of PTLD's - tumor incidence ;Primary end point(s): ratio and severe of acute bioptical confirmed rejection reaction (BANFF) as well as time of first bioptical assured rejection. | — |
Countries
Germany
Outcome results
None listed