EUCTR2012-000171-17-HU进行中（未招募）1 期
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 8 months of Treatment with Lanthanum Carbonate in Hyperphosphataemic Children and Adolescents aged 10 years to <18 years with Chronic Kidney Disease on Dialysis.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 63
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
入选标准
- •The subject cannot be enrolled in the study before all of the following
- •inclusion criteria(including test results) are met.
- •1.Aged 10 years to <18 years of age at the time of consent.
- •2. Subject or parent/legally authorised representative (LAR) understand
- •and are able,willing, and likely to fully comply with the study procedures
- •and restrictions defined in this protocol.
- •3.Male, or non-pregnant, non-lactating female who agrees to comply
- •with any applicable contraceptive requirements of the protocol.
- •4. Established CKD, on dialysis, and requires treatment for
- •hyperphosphataemia with a phosphate binder.
- •5. Serum phosphorus levels after a washout period of up to 3 weeks as
- •- Age <12 years: Serum phosphorus >6.0mg/dL (1.94mmol/L)
- •- Age 12 years and older: Serum phosphorus >5.5mg/dL (1.78mmol/L)
- •6. Ability to provide written, signed and dated (personally or via an LAR)
- •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: 72
- •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
- •1. Current or recurrent disease (eg, cardiovascular, liver, unstable and
- •uncontrolled gastrointestinal, malignancy, or other conditions) other
- •than CKD or end-stage renal disease 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 end-stage renal disease 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 solid or semi-solid foods or on Total Enteral
- •Alimentation.
- •4. Serum PTH >700pg/mL.
- •5. Known or suspected intolerance or hypersensitivity to the
- •investigational product(s), closely related compounds, or any of the
- •stated ingredients.
- •6. History of alcohol or other substance abuse within the last year.
- •7. Current use of any medication (including over-the-counter, 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. (Current use is defined as use within 1 day.) See Section 5
- •(Prior and Concomitant Treatment) for a list of prohibited and restricted
- •medications.
- •8. Weight and age of subject are outside local applicable criteria for
- •blood sample volumelimits.
- •9. Use of another investigational product within 30 days prior to
- •receiving the first dose of investigational product.
研究者
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