EUCTR2006-001485-16-AT进行中（未招募）不适用
A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD
ovartis Pharma GmbH0 个研究点目标入组 300 人开始时间: 2006年11月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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 – 65 years
- •2.Clinical diagnosis of autosomal dominant polycystic kidney disease (ADPKD), (Appendix 6)
- •3.CKD stage II/III, i.e. calculated GFR (MDRD formula) (ml/min/1.73 m²) has to be 30 - 89
- •CKD I, i.e. calculated GFR (MDRD formula) (ml/min/1.73 m²) is = 90 and a kidney volume (estimated by ultrasound) > 1000 mL
- •4.Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, 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 (see Section 8.2)
- •5.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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.CKD I (a calculated GFR = 90 mL/min/1.73m2) and a kidney volume (estimated by ultrasound) of = 1000 ml
- •2.Patients with CKD stage IV (a calculated GFR < 30 mL/min/1.73m2)
- •3.Patients with a history of subarachnoid bleeding
- •4.Patients with a history of serious infections
- •5.Patients with life-threatening urinary tract or cyst infection in the past
- •6.Patients who have received any investigational drug within four weeks prior to baseline
- •7.Patients who have been treated with any non-protocol immunosuppressive drug or treatment within one month prior to baseline
- •8.Patients with any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or any known hypersensitivity to Certican®, other drugs similar to Certican® (e.g., macrolides), or other components of the formulations (e.g. lactose)
- •9.Patients with any surgical or medical condition, which in the opinion of the investigator, preludes enrollment in the trial
- •10.Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT, AP or total bilirubin > 3 times UNL)
- •11.Patients who are HIV positive or Hepatitis B surface antigen positive or who are known to have chronic active Hepatitis C. Laboratory results obtained within 6 months prior to baseline are acceptable
- •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 unresolved history or evidence of drug or alcohol abuse
- •14.Presence of severe hypercholesterolemia (= 350 mg/dL, 9.1 mmoL/L), or hypertriglyceridemia (= 500 mg/dL, 5.6 mmoL/L), if hyperlipidemia is not sufficiently controlled by fluvastatines
- •15.Patients with white blood cell count count = 4,000/mm³, or platelet count = 100,000/mm³
- •16.Patients with a history of malignancy during the last five years, except for successfully treated localized squamous or basal cell carcinoma of the skin
- •17.Patients with any history of coagulopathy or medical condition requiring long-term anticoagulation (low-dose aspirin treatment is allowed)
- •18.Patients with abnormal physical or laboratory findings of clinical significance within two weeks prior to randomization which at the investigators discretion would interfere with the objectives of the study
- •19.Females of childbearing potential who are planning to become pregnant, who are pregnant or breast feading, and/or who are unwilling to use effective means of contraception during the study period and until six weeks after discontinuation of study medication.
- •20.Patients with a contraindication against MRI
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