EUCTR2012-000171-17-DE进行中（未招募）不适用
A Three Part Open-Label Study to Assess the Pharmacokinetics of Lanthanum Carbonate, compare the Efficacy, Safety and Tolerability of 8 weeks treatment with Lanthanum Carbonate and Calcium Carbonate using a Crossover design and Investigate the Efficacy and Safety of 12 months of Treatment with Lanthanum Carbonate in Hyperphosphataemic Children and Adolescents aged 6 months to Less Than 18 years with Chronic Kidney Disease on Dialysis.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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. Subjects 6 months to less than 18 years of age at the time of consent.
- •2. Established on solid food, i.e., not exclusively on a liquid diet.
- •3. Subject and parent or LAR understand and are able, willing, and likely to fully comply with the study procedures and restrictions defined in this protocol.
- •4. Male, or non pregnant, non lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.
- •5. Established CKD on dialysis and requires treatment for hyperphosphataemia with a phosphate binder.
- •6. Serum phosphorus levels after a washout period of up to 3 weeks:
- •Age <12 years: Serum phosphorus > 6.0mg/dL (1.94mmol/L).
- •Age 12 years and older: Serum phosphorus >5.5mg/dL (1.78mmol/L).
- •7. Ability to provide written, signed, and dated (personally or via a legally acceptable representative) informed consent/and assent, as applicable, to participate in the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •Subjects are excluded from the study if any of the following criteria are met at Visit 1.1, Part 1 or Visit 2.0, Part 2:.
- •1. Current or recurrent disease (e.g., cardiovascular, liver, unstable and uncontrolled gastrointestinal (GI), malignancy, or other conditions) other than CKD or ESRD that could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
- •2. Current or relevant history of physical or psychiatric illness, any medical disorder (except for CKD or ESRD and related co-morbidities) that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
- •3. Unable to eat semi-solid foods or on Total Enteral Alimentation.
- •4. Serum PTH > 700pg/mL.
- •5. Serum calcium >10.2mg/dL (2.54mmol/L).
- •6. Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.
- •7. History of alcohol or other substance abuse within the last year.
- •8. Current use of any medication (including over-the-counter (OTC), herbal, or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action, absorption, or disposition of the investigational product(s), or clinical or laboratory assessment.
- •9. Weight and age of subject are outside local applicable criteria for blood sample volume limits.
- •10. Use of another investigational product within 30 days prior to receiving the first dose of investigational product.
研究者
相似试验
进行中（未招募）
1 期
A study to compare treatment for hyperphosphataemia in childrensuffering from renal failure with a new product called Lanthanum oralpowder with an established treatment called calcium carbonate.EUCTR2012-000171-17-ROShire Pharmaceutical Development Ltd.63
进行中（未招募）
1 期
A study to compare treatment for hyperphosphataemia in children suffering from renal failure with a new product called Lanthanum oral powder with an established treatment called calcium carbonate.EUCTR2012-000171-17-PLShire Pharmaceutical Development Ltd.63
进行中（未招募）
不适用
A study to compare treatment for hyperphosphataemia in childrensuffering from renal failure with a new product called Lanthanum oralpowder with an established treatment called calcium carbonate.Treatment of Hyperphosphataemia.MedDRA version: 14.1Level: LLTClassification code 10020712Term: HyperphosphatemiaSystem Organ Class: 100000004861EUCTR2012-000171-17-Outside-EU/EEAShire Pharmaceutical Development Ltd.100
进行中（未招募）
1 期
A study to compare treatment for hyperphosphataemia in children suffering from renal failure with a new product called Lanthanum oral powder with an established treatment called calcium carbonate.EUCTR2012-000171-17-HUShire Pharmaceutical Development Ltd.63
进行中（未招募）
1 期
A study to compare treatment for hyperphosphataemia in children suffering from renal failure with a new product called Lanthanum oral powder with an established treatment called calcium carbonate.Treatment of Hyperphosphataemia.MedDRA version: 20.1 Level: LLT Classification code 10020712 Term: Hyperphosphatemia System Organ Class: 100000004861EUCTR2012-000171-17-CZShire Pharmaceutical Development Ltd.63