Phase IV Study to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Current practice of immune suppressive standard therapy after renal transplantation in non-risk patients is a triple therapy consisting of steroids, a calcineurin inhibitor and MMF. The aim of this clinical trial is to combine a reduction of CNI using tacrolimus and a concept of not using steroids in order to establish an immunosuppressive regimen in immunologically non-risk patients that is efficient and causes as few side effects as possible.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Freiburg
• Collaborators: Astellas Pharma GmbH; Genzyme, a Sanofi Company; Roche Pharma AG
• Treatments: Antibodies, Monoclonal; Basiliximab; Calcineurin Inhibitors; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Tacrolimus; Thymoglobulin

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 to 75 years of age

• AB0-compatible

• Negative crosshatch

• Patients with a signed informed consent form

• Women of child-bearing age must agree to an efficient contraception

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 < 5 years. Exception: basaloma or squamous cell carcinoma of the skin after successful therapy

• Female patients who do not use a safe method of contraception

• 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

• Patients currently, resp. within the last 30 days, participating in other studies

• Primary focal-sclerosing glomerulonephritis and membranoproliferative glomerulonephritis as an underlying disease

• Autoimmune disease as underlying disease (collagen diseases, colitis, HUS, SLE) which might require chronic cortisone therapy

• Additional disease requiring temporary or chronic cortisone therapy (including inhalation medicine)

• Chronic hepatitis B and hepatitis C infection

• Thrombopenia < 70.000/mm3 or leukopenia < 2.500/mm3 or neutropenia < 1500/ mm3.

• Patients with hepatocirrhosis Child B or C or another severe disease of the liver

• 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).

• Patients who possibly depend on the sponsor or the trial physician

• Patients with signs of drug abuse or alcohol abuse

• Patients taking additional medicines with known interactions with the immune suppressive substances (MMF and tacrolimus) that preclude an adequate control of the immunosuppression

• Cold ischemia time of donor kidney > 30 hours

• Pregnant or nursing patients