EUCTR2013-001770-19-DE进行中（未招募）1 期
6 month, multi-center, open-label, prospective, randomized trial, investigating a standard regimen of an advagraf based immunosuppressive regimen in de-novo renal transplant patients versus a slower dose tapering and lower starting dose of Advagraf - Slow and low
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- •1. Male or female allograft receipients at least 18 years old
- •2. primary or secondary kidney transplantation
- •3. deceased or living dondor
- •4. normal immunological risk profile,
- •PRA level > 20%,
- •AB0-comaptible donation,
- •negative Crossmatch
- •5. informed consent of the Patient
- •6. Allowance to contact the familys doctor and/or neprologist for study relevant data
- •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 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1. Graft loss due to severe rejection within the first year after transplantation (in case of secondary transplantation)
- •2. Multi- organ recepient
- •3. Patients receiving a kidney from a non beating donor
- •4. Complete HLA-identical living donor (twins)
- •5. Patients with a history of malignancy during the last five years ( except squamous or basal cell carcinoma of the skin after successful treatment)
- •6. Patients with uncontrolled infectious disease, particularly patients who are HIV positiv or suffer from chronic hepatitis B or C or tuberculosis
- •7. Patients with severe gastroenteric disorder, particularly severe diarrhoe and symptoms of enteric malabsorption
- •8. Patients suffering from liver cirrhosis Child B or C or other severe liver disease (ASAT, ALAT, GammaGT = 3-fold increased)
- •9. Thrombopenia <70.000/mm3
- •10. Leukopenia <2.500/mm3
- •11. Participation in another clinical trial within the last 4 weeks prior to inclusion
- •12. Estimate addiction or other disorders that do not allow the person concerned, the nature and scope and possible consequences of the clinical Trial
- •13. Pregnant or breast feeding women
- •14. Women of childbearing age, except women who meet any of the following criteria: - post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum > 40 U / ml) - Postoperatively (6 weeks after bilateral oophorectomy withor without hysterectomy) - Regular and correct use of a contraceptive method with error rate <1% per year (eg implants, depot injections, oral contraceptives, intrauterine device IUD); Sexual abstinence - vasectomy of the partner
- •15. Evidence that the patient is likely to fail to comply with the protocol (eg lack of cooperation)
- •16. Hypersensitivity to tacrolimus or a product listed in the prescribing information other component as well as to other macrolides
研究者
相似试验
进行中（未招募）
不适用
A six-month, prospective, multicentre, open-label, parallel-group, randomized study of the safety, tolerability and efficacy of myfortic (ERL080) with Simulect, cortocosteroids and two different levels of tacrolimus in de novo renal transplant recipients.de novo renal transplantEUCTR2005-001518-42-GBovartis Pharma Services AG288
进行中（未招募）
不适用
A six-month, prospective, multicenter, open label, parallel, randomized study of the safety, tolerability and efficacy of myfortic® (ERL080) with Simulect®, corticosteroids and two different levels of tacrolimus in de novo renal transplant recipientsEUCTR2005-001518-42-ESovartis Farmaceútica S.A288
进行中（未招募）
不适用
PALMFlexS: Paliperidone Palmitate Flexible Dosing in SchizophreniaMedDRA version: 14.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersSchizophreniaEUCTR2009-018022-30-DKJanssen-Cilag International N.V.1,000
进行中（未招募）
不适用
PALMFlexS: Paliperidone Palmitate Flexible Dosing in SchizophreniaMedDRA version: 17.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersSchizophreniaEUCTR2009-018022-30-PTJanssen-Cilag International N.V.1,000
进行中（未招募）
不适用
A 6-month, open label, prospective, multicenter, international, exploratory study of a transition to flexibly dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully treated with oral or long-acting injectable antipsychotics. - PALMFlexSMedDRA version: 12.1Level: LLTClassification code 10039626Term: SchizophreniaSchizophreniaEUCTR2009-018022-30-HUJanssen-Cilag International N.V.1,000