EUCTR2006-006652-35-GB进行中（未招募）1 期
A pilot study to evaluate of the impact on bone density during treatment with mycophenolate mofetil, daclizumab in combination with ciclosporin converted to sirolimus with steroid as mainstay immunosuppression, in comparison to current standard immunosuppression (daclizumab,mycophenolate, ciclosporin and corticosteroids) in renal transplantation. - Bone Protection study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •The enrolled patients must fulfil the following inclusion criteria:
- •1.Male and female patients between 18 and 75 years of age
- •2.Patients scheduled for a single-organ, renal transplantation from living or deceased donors. Patient receiving second renal transplants can be included, provided that the previous graft was not lost from acute rejection within the first year.
- •3.Patients capable of understanding the purposes and risks of the study, who give written informed consent and who are willing to participate to and comply with the study.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The following groups of patients will not be included in the study:
- •1.Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method before beginning study drug therapy, during therapy and for 4 months following their last dose of the drugs administered within this clinical study.
- •2.Patients receiving the third or higher renal transplant.
- •3.Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy.
- •4.Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
- •5.Patients with evidence of an active systemic infection requiring the continued use of antibiotics or evidence of an HIV infection, or the presence of a chronic active hepatitis B (HBs-Ag positive) or C.
- •6.Patients with history of malignancy (except successfully treated localized non-melanistic skin cancer).
- •7.Patients with active peptic ulcer disease.
- •8.Patients with evidence of an active liver disease
- •9.Patients with severe anemia (Hb<6 g/dl) leucopenia (WBC<2500/mm3), thrombocytopenia (Tc <100’000/mm3)
- •10.Patients for whom the investigator considers a treatment with the following medications necessary:
- •-azathioprine,
- •-methotrexate,
- •-cyclophosphamide,
- •-polyclonal and monoclonal anti-lymphocyte antibodies (e.g. OKT3, ATG), e.g. used for induction in immunological high-risk patients,
- •-basiliximab,
- •-mycophenolate - sodium
- •-other investigational drugs.
- •11.Known hypersensitivity or absolute contraindications to any of the medications administered in the context of the study or any other substances present in the study medications
- •12.Panel Reactive Antibody (PRA) > 30% within 6 months prior to enrollment;
- •13.Cold ischemia time of the graft of more than 30 hours;
- •14.Patients who had received an investigational new drug within the last three months.
- •15.Patients previously treated with daclizumab or basiliximab.
研究者
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