EUCTR2006-006535-53-IT进行中（未招募）不适用
A Phase III, Multi.centre, Double-blind, randomized, Placebo controlled, Multiple fixed-dose Study of MCI-196 versus placebo in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia and Dyslipidaemia (Incorporating Two Parallel High Dose Groups)
MITSUBISHI PHARMA CORPORATIO0 个研究点目标入组 595 人开始时间: 2008年4月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 595
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
- •Criteria for Inclusion
- •A subject will be eligible for participation in this study at screening and baseline (if applicable) if all the following criteria are met:
- •1.The subject is capable of reading and comprehending the informed consent and complying with study procedures, and provides written informed consent.
- •2.The subject is male or female, 18 to 80 years of age.
- •3.The subject has a diagnosis of Chronic Kidney Disease (Stage V) as defined by the K/DOQI Guidelines (i.e. GFR < 15mL/min/1.73m2 or dialysis.)
- •4.The subject is clinically stable (as judged by the Investigator) on haemodialysis or peritoneal dialysis for at least 3 months prior to screening.
- •5.The subject has stable phosphate control (as judged by the Investigator) using phosphate-binding medication for at least 3 months prior to screening.
- •6.The subject is undergoing regular dialysis treatment:
- •oIf the subject is on haemodialysis, this should be scheduled to occur 3 times per week in a hospital or centre setting. The duration must be between 3 to 5 hours or if high-flux dialysis, a minimum of 2.5 hours, depending on the standard of care in each centre.
- •oIf the subject is on peritoneal dialysis, this should be scheduled to be either daily APD (Automated Peritoneal Dialysis) or CAPD (Continuous Ambulatory Peritoneal Dialysis), the latter employing at least 3 bag changes per day (1 bag = 1.5L).
- •7.The subject has serum phosphorus levels < 2.1 mmol/L (6.5 mg/dL) at screening.
- •8.The subject has calcium dialysate content between 1.00 and 1.75 mmol/L (2.0 to 3.5 mEq/L), depending on the standard of care in each centre. Calcium dialysate content should remain constant for the duration of the study.
- •9.The subject is on a stabilised phosphorus diet, as considered appropriate by the physician.
- •10.The subject has baseline Kt/V (single pool) of at least 1.2 for haemodialysis subjects, and a weekly Kt/V value of at least 1.8 for peritoneal dialysis subjects.
- •11.The subject, if female and of child-bearing potential, has a negative serum pregnancy test. Sexually active females must agree to take appropriate steps not to become pregnant during the course of the clinical study. Specifically, to participate in this study, sexually active females must be 2 or more years post-menopausal, surgically sterilized, or using an accepted form of contraception (oral contraceptives for at least 3 months or an intrauterine device for at least 2 months prior to the start of the screening visit or various barrier methods, such as diaphragm or combination condom and spermicide).
- •12.Male subjects must agree to use appropriate contraception during the course of the clinical study.
- •Additional Criteria for Randomisation at Baseline
- •13.The subject has a serum phosphorus level that is ≥ 2.10 mmol/L (6.5 mg/dL) and is at least 15% greater than at the serum phosphorus level measured at the visit at week -4 (for all patients), after the completion of the washout periods.
- •The serum phosphorus level is ≥ 2.58 mmol/L (8.0 mg/dL) at any time during the phosphate binder washout period.
- •14.The subject has serum LDL-C level ≥ 1.82 mmol/L (70 mg/dL).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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
- •Criteria for Exclusion
- •A subject meeting any of the following criteria at screening and baseline (if applicable) will be ineligible to participate in this study:
- •1.The subject has current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
- •2.The subject has a serum albumin level < 30.0 g/L.
- •3.The subject has a PTH level >1000pg/mL
- •4.The subject has a body mass index (BMI) 16.0 kg/m2 or > 40.0 kg/m2.
- •5.The subject has serum LDL-C level > 4.94 mmol/L (190 mg/dL)
- •6.The subject has a serum triglycerides level > 6.76 mmol/L (600 mg/dL)
- •7.The subject has currently, or a history of, significant gastrointestinal (GI) motility problems, including dysphagia or swallowing difficulty, or GI abnormalities such as chronic or severe constipation, sigmoid colitis, ulcers, or major GI surgery.
- •8.The subject has biliary obstruction or proven liver dysfunction, i.e., hepatitis, cirrhosis, hepatorenal syndrome, or has liver function tests 3 times the normal values for at least 2 of the measurements (ALT, AST, alkaline phosphatase, and gamma-glutamyl-transferase).
- •9.The subject is known to have a positive test for hepatitis B surface antigen, or HIV 1 and 2 antibodies. The subject is known to have a positive test for hepatitis C antibody with high transaminase (>3 times the upper limit of normal) or PCR positive. Note: Subjects testing positive for Hepatitis C antibody may be included into the study if, in the opinion of the investigator, there is no evidence of active disease present, as confirmed by PCR
- •10.The subject has a history of clinically significant severe lactose intolerance or sensitivity (the placebo tablets have a high lactose content), as judged by the Investigator.
- •11.The subject has a history of substance or alcohol abuse within the last year.
- •12.The subject has seizure disorders.
- •13.The subject has a history of drug or other allergy that contraindicates their participation.
- •14.The subject is using any of the following drugs:
- •?over-the-counter products containing calcium, magnesium and aluminium, and/or nutritional supplements which can not be stopped during the study period
- •15.The subject has a temporary catheter as a vascular access and is showing active signs of inflammation or infection as a result of this.
- •16.The subject has participated in a clinical study with any experimental medication in the last 30 days, or an experimental biological product within the last 90 days, prior to signing of informed consent.
- •17.The subject has had prior exposure to MCI-196 in the past 12 months.
- •18.If on peritoneal dialysis, the subject has a recent history of peritonitis (within the previous 3 months).
研究者
相似试验
进行中（未招募）
不适用
A phase III, multi-center, double-blind, randomized, vehicle controlled trial in a parallel-group design to evaluate the efficacy and safety of two formulations of Muxan containing 0.5 % or 1 % chloramine-T compared to vehicle in patients aged 12 years or older with acute herpes labialisMale or female patients, aged 12 years or older (first part of the trial: only patients aged 18 years or older), with an adequate history of recurrent herpes labialis and an acute episode of herpes labialis will be investigated.MedDRA version: 12.1Level: LLTClassification code 10019942Term: Herpes labialisEUCTR2010-021144-17-DEEngelhard Arzneimittel GmbH & Co. KG
进行中（未招募）
1 期
Safety and efficacy of LCI699 for the treatment of patients with Cushing's diseaseCushing's diseaseEUCTR2013-004766-34-ITOVARTIS FARMA S.p.A.137
进行中（未招募）
1 期
Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's diseaseEUCTR2013-004766-34-DEovartis Pharma Services AG137
进行中（未招募）
1 期
Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's diseaseCushing's diseaseMedDRA version: 20.0 Level: LLT Classification code 10011651 Term: Cushing's disease System Organ Class: 100000004860EUCTR2013-004766-34-ATovartis Pharma Services AG132
进行中（未招募）
1 期
Safety and efficacy of LCI699 for the treatment of patients with Cushing's diseaseCushing's diseaseEUCTR2013-004766-34-ESovartis Farmacéutica, S.A.132