Eligibility NCT00724022 Renal Transplantation Inclusion Criteria Exclusion Criteria Third or multiple transplantation Yes
No
Transplantation per a non-heart beating donor Yes
No
HLA-identical living donation Yes
No
Incompatibility to study medication (allergy, intolerance, hypersensitivity) Yes
No
Patients with existing malignant underlying disease or tumour anamnesis < 5 years. Exception: basaloma or squamous cell carcinoma of the skin after successful therapy Yes
No
Female patients who do not use a safe method of contraception Yes
No
Patients with clinically significant, uncontrolled infectious diseases (incl. HIV) and/or severe diarrhoea, emesis, active malabsorption of the upper gastrointestinal tract or active peptic ulcer Yes
No
Patients currently, resp. within the last 30 days, participating in other studies Yes
No
Primary focal-sclerosing glomerulonephritis and membranoproliferative glomerulonephritis as an underlying disease Yes
No
Autoimmune disease as underlying disease (collagen diseases, colitis, HUS, SLE) which might require chronic cortisone therapy Yes
No
Additional disease requiring temporary or chronic cortisone therapy (including inhalation medicine) Yes
No
Chronic hepatitis B and hepatitis C infection Yes
No
Thrombopenia < 70.000/mm3 or leukopenia < 2.500/mm3 or neutropenia < 1500/ mm3. Yes
No
Patients with hepatocirrhosis Child B or C or another severe disease of the liver Yes
No
Patients with symptoms of a significant somatic or psychiatric / mental illness. Patients who are not able to realize nature, relevance and consequences of the clinical trial and who are not able to comply, to cooperate and communicate adequately and to follow the instructions of the study or even to give their informed consent (according to § 40 article 4 and § 41 article 2 and 3 AMG). Yes
No
Patients who possibly depend on the sponsor or the trial physician Yes
No
Patients with signs of drug abuse or alcohol abuse Yes
No
Patients taking additional medicines with known interactions with the immune suppressive substances (MMF and tacrolimus) that preclude an adequate control of the immunosuppression Yes
No
Cold ischemia time of donor kidney > 30 hours Yes
No
Pregnant or nursing patients Yes
No
