EUCTR2004-004346-40-DE进行中（未招募）不适用
Full title of the trial : Multi-center, open-label, prospective, randomized, parallel group study investigating a CNI-free regimen with Myfortic® and Certican® in comparison to standard therapy with Myfortic® and Sandimmun® Optoral in de novo renal transplant patients - ZEUS
ovartis Pharma GmbH0 个研究点目标入组 300 人开始时间: 2005年3月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Males or females, aged 18 – 65 years
- •- Recipients of de novo cadaveric, living unrelated or living related kidney
- •transplants
- •- Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.
- •To be fulfilled at Baseline 2 (prior to randomization)
- •In addition to the above criteria the following must be met at BL2 prior to randomization.
- •- Patients have to be on an immunosuppressive regimen with Myfortic® (target dose: 1440 mg/day, if tolerated; minimal dose: 720 mg/day), Sandimmun® Optoral, and corticosteroids.
- •- Patients with an actual serum creatinine = 3.0 mg/dl
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- More than one previous renal transplantation
- •- Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- •- Patients receiving a kidney from a non-heart beating donor
- •- Donor age: > 5 years and < 65 years
- •- Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
- •- Patients who are recipients of A-B-O incompatible transplants
- •- Patients with a historical or current peak PRA of > 25%
- •- Patients with already existing antibodies against the HLA-type of the receiving transplant
- •- Patients with any known hypersensitivity to Simulect®, Certican®, mycophenolic acid, cyclosporine A, other drugs similar to Certican® (e.g., macrolides), or other components of the formulations (e.g. lactose)
- •- Patients who have received an investigational immunosuppressive drug within four weeks prior to study entry (Baseline visit 1)
- •- Patients with thrombocytopenia (platelets < 75,000/mm³), with an absolute neutrophil count of < 1,500/mm³ or leucopenia (leucocytes < 2,500/mm³), or hemoglobin < 6 g/dL
- •- Patients with symptoms of significant somatic or mental illness. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent
- •- Patients with a history of malignancy during the last five years, except squamous or basal cell carcinoma of the skin
- •- Patients who are HIV positive or Hepatitis B surface antigen positive or Hepatitis C virus positive. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded.
- •- Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT or total bilirubin > 3 times UNL)
- •- Presence of a clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study
- •- Patients receiving drugs known to interact with CsA and/or everolimus according to the list provided in Appendix 3 to this protocol.
- •To be fulfilled at Baseline 2 (prior to randomization)
- •In addition to the above criteria the following must be met at BL2 prior to randomization.
- •- Graft loss or death
- •- Changes to the immunosuppressive regimen prior to randomization due to immunologic reasons.
- •- Patients who suffered from severe rejection (more than or equal to BANFF II acute rejection), recurrent acute rejection, or steroid resistant acute rejection.
- •- Patients with thrombocytopenia (platelets < 75,000/mm³), with an absolute neutrophil count of < 1,500/mm³ or leucopenia (leucocytes < 2,500/mm³), or hemoglobin < 6 g/dL
- •- Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT or total bilirubin > 3 times ULN)
- •- Proteinuria > 1g/day
- •- Dialysis dependency at randomization visit (Visit 5, BL2).
- •- Patients with clinically significant infection requiring continued therapy which would interfere with the objectives of the study
- •- Presence of intractable immunosuppressant complications or side effects (e.g., severe gastrointestinal adverse events) at randomization visit (Visit 5, BL2)
研究者
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