EUCTR2006-007021-32-DE进行中（未招募）1 期
Multi-center, open-label, prospective, randomized, parallel group, long-term study investigating a standard regimen in de novo kidney transplant patients versus a CNI-free regimen and a CNI-low dose regimen - HERAKLES
ovartis Pharma GmbH0 个研究点目标入组 450 人开始时间: 2007年4月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
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
- •1.Males or females, aged 18 – 70 years
- •2.Recipients of de novo cadaveric, living unrelated or living related kidney transplants
- •3.Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at Baseline visit 1, 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
- •4.Patients who are willing and able to participate in the study and from whom written informed consent has been obtained
- •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
- •1.More than one previous renal transplantation
- •2.Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- •3.Patients receiving a kidney from a non-heart beating donor
- •4.Donor age: < 5 years or > 70 years
- •5.Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
- •6.Patients who are recipients of A-B-O incompatible transplants
- •7.Patients with a historical or current peak PRA of > 25% (current = 3 months)
- •8.Patients with already existing antibodies against the HLA-type of the receiving transplant
- •9.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)
- •10.Patients who have received an investigational immunosuppressive drug within four weeks prior to study entry (Baseline visit 1)
- •11.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
- •12.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
- •13.Patients with a history of malignancy during the last five years, except squamous or basal cell carcinoma of the skin
- •14.Patients who are HIV, HCV, or Hepatitis B surface antigen positive
- •15.Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT or total bilirubin > 3 times UNL)
- •16.Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
- •17.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
- •18.Evidence of drug or alcohol abuse
- •19.Patients receiving drugs known to strongly interact with CsA and/or everolimus according to the list provided in Appendix 3 to this protocol should be excluded, if in the opinion of the investigator this drug interaction interferes with the objectives of the study, namely a clinical meaningful potentiation of renal dysfunction and/or maintenance of adequate immunosuppressive drug levels
研究者
相似试验
进行中（未招募）
不适用
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 a calcineurin inhibitor (Sandimmun® Optoral or Prograf®) in stable renal transplant patients - APOLLOEUCTR2005-001013-18-DEovartis Pharma GmbH
进行中（未招募）
不适用
Multi-center, open-label, prospective, randomized, parallel group study investigating an intensified Myfortic® dosing regimen in comparison to a standard dosing regimen of Myfortic® in combination with Sandimmun® Optoral and Corticosteroids in de novo renal transplant patients - OptiMyzeDe novo renal transplant recipientsMedDRA version: M15Level: LLTClassification code 10023438EUCTR2005-006138-14-DEovartis Pharma GmbH120
进行中（未招募）
1 期
Study to compare a tacrolimus Hexal® based regimen versus a Prograf® based regimen in renal transplantatioEUCTR2011-003795-36-DEovartis Pharma GmbH
进行中（未招募）
1 期
Multicentre, prospective, randomized, open-label, controlled study in de novo kidney transplant recipients to evaluate the impact of cyclosporine or steroid withdrawal at 3 months on graft function, patient and graft survival, and cardiovascular surrogate markers during the first five years after transplantation. - CistcertPreservation of renal function after kidney transplantation in a 5-year, multicentre, prospective, randomized, open-label, controlled studyPatients will be randomized within 24 hours prior to transplantation.?Group 1: Simulect + Neoral + Myfortic + steroid stop at 3 months?Group 2: Simulect + Neoral (decrease dose in one week at mo 3 and replace by Certican) + Myfortic + steroid maintenance.EUCTR2007-005844-26-BEAntwerp University Hospital
进行中（未招募）
3 期
A clinical trial to study the effects of two drugs, R-TPR-026 andAranesp® in patients for correction of anemia due to Chronic Kidney DiseaseCTRI/2013/09/004005Reliance Life sciences Pvt Ltd104