DRKS00000452已完成4 期
HARMONY:A triple arm, prospectively randomized, multi-center study phase IV to evaluate calcineurin inhibitor reduced and steroid-free immunosupression in low immunological risk patients. - Harmony
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 631
研究概览
简要总结
Summary Background Standard practice for immunosuppressive therapy after renal transplantation is quadruple therapy using antibody induction, low-dose tacrolimus, mycophenolate mofetil, and corticosteroids. Long-term steroid intake signifi cantly increases cardiovascular risk factors with negative eff ects on the outcome, especially post-transplantation diabetes associated with morbidity and mortality. In this trial, we examined the effi cacy and safety parameters of rapid steroid withdrawal after induction therapy with either rabbit antithymocyte globulin (rabbit ATG) or basiliximab in immunologically low-risk patients during the fi rst year after kidney transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •To be eligible for the study, patients must fulfill all of the following 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 crossmatch.
- •Patients with a signed informed consent form.
- •Women of child-bearing age must agree to an efficient contraception.
排除标准
- •Exclusion Criteria:
- •Patients may not be allowed to participate in the clinical study, if they fulfill one of the following 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.
研究者
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