EUCTR2011-003795-36-DE进行中（未招募）1 期
Multi-center, open-label, prospective, randomized, parallel group study investigating a tacrolimus Hexal® based regimen versus a Prograf® based regimen in de novo renal transplant recipients
ovartis Pharma GmbH0 个研究点开始时间: 2011年10月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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. Male or female renal allograft recipients aged between 18 and 64 years
- •2. Patients who have received a primary or secondary kidney transplant from a de novo deceased, living unrelated or living related donor aged < 65 years
- •3. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained
- •4. Recipient of a kidney allograft with a cold ischemia time (CIT) < 24 hours
- •5. Female patients must have a negative pregnancy test prior to study enrollment.
- •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 81
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- •2. Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
- •3. Patients receiving a kidney from a non-heart beating donor
- •4. Patients who are recipients of A-B-O incompatible transplants
- •5. Patients with a current Panel Reactive Antibody (PRA) level of > 20% PRA levels within 4 months prior to enrollment are acceptable
- •6. Patients with already existing antibodies against the HLA-type of the receiving transplant (in the knowledge of the investigator at the time point of transplantation)
- •7. Patients with any known hypersensitivity to tacrolimus or mycophenolic acid, to drugs with similar chemical structures or other components of the formulations (e.g. lactose, see also SmPCs)
- •8. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- •9. Patients with thrombocytopenia (platelets < 100,000/mm³), with an absolute neutrophil count of < 2,000/mm³ or leucopenia (leucocytes < 3,000/mm³), or hemoglobin < 8 g/dL
- •10. Patients with symptoms of significant 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
- •11. Patients with a history of malignancy during the last five years, except squamous or basal cell carcinoma of the skin
- •12. Patients who are HIV positive
- •13. Patient who received an allograft from a Hepatitis B surface Antigen (HBsAg) or a
- •Hepatitis C Virus (HCV) positive donor
- •14. HBsAg and/or a HCV positive patient with an abnormal liver enzyme profile (ALT or AST > 3 times UNL). Viral serology results obtained within 6 months prior to enrollment are acceptable
- •15. Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST or ALT > 3 times UNL)
- •16. Evidence of drug or alcohol abuse
- •17. Patients, who have already been randomized into this trial earlier must not be included a second time.
- •o who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml))
- •o who are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception (Pearl Index <1**) during and up to at least 6 weeks after the end of treatment. A negative pregnancy test (serum) for all women entering menarche is required with sufficient lead time before inclusion
- •*definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy
- •**examples of particularly reliable methods with Pearl Index (PI) <1, according to guidelines of Deutsche Gesellschaft für Gynäkologie und Geburtshilfe:
- •? Combination pill with estrogen and gestagen (no mini-pill, PI=0.1-0.9)
- •? Vaginal ring (PI=0.65 uncorr.; 0.4 corr.)
- •? Contraceptive patch (PI= 0.72 uncorr.; 0.9 corr.)
- •? Estrogen-free ovulation inhibitors (PI=0.14)
- •? Progestin-containing contraceptives (PI=0-0.08)
- •? Injectable 3-month depot progestins (PI=0.3-1.4; 0.88 corr.)
- •? Intra-uterine progestine device (PI=0.16)
- •? Total abstinence (when this is in line with the preferred and usual lifest
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
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 - HERAKLESde novo kidney transplant patientsMedDRA version: 9.1Level: LLTClassification code 10023439Term: Kidney transplant rejectionEUCTR2006-007021-32-DEovartis Pharma GmbH450
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