Description:

ODM derived from http://clinicaltrials.gov/show/NCT00724022

Link:

http://clinicaltrials.gov/show/NCT00724022

Keywords:
Versions (3) ▾
  1. 12/9/13
  2. 4/16/14
  3. 6/21/17
Uploaded on:

June 21, 2017

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License:
Creative Commons BY 4.0
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Triple Arm, Prospectively Randomized Multi Centre Study Phase IV to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation in Non-risk Patients DRKS00000452 NCT00724022 DRKS00000452

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age 18 Years to 75 Years
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%.
AB0-compatible
Negative crossmatch
Patient's Signature on 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