EUCTR2012-002582-35-DE进行中（未招募）不适用
A Multi-centre, Open-label Study Evaluating the Safety and Tolerability of Colestilan (MCI-196) in Paediatric Subjects with Chronic Kidney Disease Stages 3b to 5 and with Hyperphosphataemia not on Dialysis
Mitsubishi Tanabe Pharma Corporation (MTPC)0 个研究点目标入组 45 人开始时间: 2012年11月13日最近更新:
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
- 45
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
- •Main inclusion criteria for enrolment into this study:
- •Children aged 2 years to <18 years with CKD stages 3b to 5, not on dialysis (stage 3b is defined as a glomerular filtration rate below 45 mL/min/1.73 m²).
- •The subject has a documented diagnosis of hyperphosphataemia, as demonstrated by serum phosphorus (P) levels above the age-related upper limit of normal (ULN) (Kidney Disease Outcomes Quality Initiative [KDOQI] Clinical Practice Guidelines for Nutrition in Children with CKD updated 2008).
- •The subject is on a stable P diet at baseline (as judged by the Investigator).
- •Inclusion criteria for subjects not currently treated with phosphate binders:
- •The subject, with serum P not controlled despite being on an appropriate P diet, must demonstrate serum P levels >1.5 standard deviation (SD) above the KDOQI 2008 age-related mean value at any time during the screening period.
- •Such subjects do not require wash-out and should proceed to baseline for the next visit if additional screening visits are not required.
- •Baseline inclusion criteria for subjects treated with phosphate binders:
- •The subject must have demonstrated serum P levels >1.5 SD above the KDOQ 2008 age-related mean value at any time during the wash-out period (after stopping phosphate binders), and;
- •The subject must demonstrate an increase in serum P levels by at least 10% above the pre wash-out level (after stopping phosphate binders).
- •Note: should a subject fail to meet any of the above criteria, the subject is permitted to be re-screened once after an interval of at least three months.
- •Refer to protocol for a complete list of inclusion criteria.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 45
- •F.1.2 Adults (18-64 years) no
- •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
- •A subject meeting any of the following criteria is ineligible to participate in this study:
- •The subject has been diagnosed with hypocholesterolaemia (i.e., cholesterol levels below age-related normal ranges, per local practices)
- •The subject has current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose him/her to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, make the subject unsuitable for inclusion in the study (e.g., the subject currently has or has had a history of seizure disorders, dysphagia, swallowing disorders, predisposition to or current bowel obstruction, ileus or gastrointestinal [GI] disorders such as chronic or severe constipation [as judged by the Investigator], intestinal stenosis, intestinal diverticulum, sigmoid colitis, GI ulcers, current or a history of GI bleeding, or major GI tract surgery)
- •The subject cannot stop treatment (prescription or over-the-counter) of any of the following orally taken medications during the wash-out period: any product containing calcium (Ca), magnesium (Mg), aluminium compounds, sevelamer, lanthanum, ketosteril
- •The subject is receiving immunosuppressant treatment for any medical condition at the baseline visit or is expected to receive such treatment during the course of the study
- •The subject is considered as unstable on his/her current treatment for CKD within one month prior to screening (e.g., subjects starting treatment with vitamin D or its analogues, or other agents/procedures that may influence bone mineral metabolism [i.e, serum P and Ca levels]
- •Exclusion criteria for subjects treated with phosphate binders:
- •The subject was treated with a combination of two or more phosphate binders within one month prior to screening
- •Refer to protocol for a complete list of exclusion criteria.
研究者
相似试验
进行中（未招募）
不适用
A clinical study to investigate how different doses of MCI-196 lower phosphate levels in patients suffering from a condition called hyperphosphatemia (high levels of phosphorus in the blood), who have stage 3b to 5 chronic kidney disease and are not on dialysis.HyperphosphataemiaMedDRA version: 17.1Level: PTClassification code 10020711Term: HyperphosphataemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-002582-35-GBMitsubishi Tanabe Pharma Corporation (MTPC)45
进行中（未招募）
1 期
Safety and diagnostic Efficacy of Mangoral in Patients with abnormal liver cells and reduced kidney functioMRI in terms of visualization of detected focal liver lesions in patients with known or Suspected focal liver lesions and severe renal impairmentMedDRA version: 22.1Level: LLTClassification code 10028049Term: MRISystem Organ Class: 100000004848EUCTR2019-001599-12-ITAscelia Pharma AB197
进行中（未招募）
1 期
A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients with Known or Suspected Focal Liver Lesions and Severe Renal ImpairmentEUCTR2019-001599-12-SEAscelia Pharma AB197
招募中
3 期
Safety and Efficacy of Triple Combination Therapy in Patients with Glaucoma or Ocular HypertensioCTRI/2010/091/002922Allergan India Private Limited, Level 2, Prestige Obelisk, No. 3 Kasturba Road, Bangalore, Karnataka, IndiaAllergan, Inc., Irvine, California, USA120
进行中（未招募）
1 期
A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients with Known or Suspected Focal Liver Lesions and Severe Renal ImpairmentMRI in terms of visualization of detected focal liver lesions in patients with known or Suspected focal liver lesions and severe renal impairmentMedDRA version: 22.1Level: LLTClassification code 10028049Term: MRISystem Organ Class: 10022891 - InvestigationsEUCTR2019-001599-12-DEAscelia Pharma AB197