Certican® (Everolimus) Against Cytomegalovirus Disease in Renal Transplant Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- relative changes in CMV-load (copies/mL), as determined by qCMV-PCR from whole blood throughout the observational period
研究概览
简要总结
A prospective, randomized safety and efficacy study of Certican® as add-on therapy against CMV disease in renal transplant recipients
OBJECTIVES:
Primary Objective:
To demonstrate efficacy of Certican® as add-on therapy against CMV disease in comparison to either valcyte® (valganciclovir) or cymevene® (ganciclovir) alone, evaluated by quantitative measurement of CMV-DNA with PCR from the blood (qCMV-PCR)
Secondary Objectives:
To assess safety and tolerability of Certican® in patients with CMV- disease To study the effects of Certican® treatment on quality of life
详细描述
DESIGN / PHASE Prospective, single-center, randomized, parallel group, controlled, phase II study.
PATIENTS / GROUPS 40 patients in 2 groups 20 patients per group Randomization ratio 1:1, no stratification
INVESTIGATIONAL DRUG Oral MED 1: Certican® initial dose: 1,5-3 mg day target trough level: 3-8 ng/mL (first levels will be performed after 3 days and then adjusted until - according to the judgment of the clinical investigator - a stable degree of immunosuppression is reached; thereafter Certican® trough levels will be performed at the scheduled appointments)
COMPARATIVE DRUG No therapy (add-on design
CONCOMITANT MEDICATION Allowed The concomitant immunosuppressive medication will be adjusted to the additional administration of Certican®. For example, if the patient already receives cyclosporine A or tacrolimus, this will be adjusted, according to the current recommendations4 at the judgment of the clinical investigator
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CMV-disease after renal transplantation, i.e.,(1.) CMV present in the blood, and (2.) one of the following symptoms (for viral syndrome, from the American Society of Transplantation recommendations for use in clinical trials1):
- •body temperature ≥ 38°C
- •new or increased significant malaise
- •leucopenia (< 3500/mL)
- •atypical lymphocytosis ≥ 5%
- •thrombocytopenia (platelets < 100.000/mL)
- •no other cause of symptoms/signs identified
- •informed consent of the patient
排除标准
- •patients with a known hypersensitivity to everolimus, sirolimus or any of the excipients
- •administration of strong CYP3A4 Inhibitors (e.g. ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin) and inducers (rifampicin), unless the benefit outweighs the risk, according to the judgment of the clinical investigator
- •acute rejection episodes in the first 3 months after renal transplantation
- •active hepatitis in the previous month
- •Significant proteinuria (> 0.8g/24h Urine)
- •hepatic impairment, according to the criteria defined by Bénichou et al.2: a singular elevation of GPT or conjugated bilirubin to a value twice above the normal level, or a combined elevation of GOT, AP, and total bilirubin, given that at least one parameter is twice above the normal level
- •hematocrit < 25%
- •any significant wound healing disorder (anamnestic)
- •blood white blood cell (WBC) count < 3000/mL
- •platelets < 50.000/mL
- •severe dyslipidemia (cholesterol >300mg/dL, triglycerides > 350mg/dL)
- •uncontrolled hypertension (continuous episodes of hypertension above 140/90 (WHO classification and American Society of Transplantation recommendations 3) despite adequate hypertensive therapy)
- •uncontrolled hyperuricemia (uric acid > 8mg/dL)
- •pregnancy
- •any immunosuppressive protocol which does not allow the addition of Certican®, according to the judgment of the clinical investigator
研究组 & 干预措施
1 Certican + Valganciclovir
Valganciclovir will be administered and Certican (everolimus) will be added as immunosuppression
干预措施: Certican (everolimus) + valganciclovir (Drug)
2 Valganciclovir alone
Valganciclovir will be added alone.
干预措施: Valganciclovir (Drug)
结局指标
主要结局
relative changes in CMV-load (copies/mL), as determined by qCMV-PCR from whole blood throughout the observational period
时间窗: 2 years
次要结局
- CMV-load (copies/mL) after 1-8 weeks, in months 3, 4, 6 and 12; Time (in weeks) until the CMV-load reaches ≤600 copies/mL(2 years)
研究者
Marcus Saemann
Ass. Prof. Dr. Marcus Säemann
Medical University of Vienna