A 3-part Open-label Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Compare the Efficacy, Safety and Tolerability of 8 Weeks of 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

Shire Pharmaceutical Development Ltd.0 个研究点目标入组 63 人开始时间: 2013年10月9日最近更新: 2019年2月28日

适应症

试验速览

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•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 follows:
•- 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: 65
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•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 semi-solid foods or on Total Enteral Alimentation.
•4. Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.
•5. History of alcohol or other substance abuse within the last year.
•6. 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.
•7. Weight and age of subject are outside of local applicable criteria for blood sample volumelimits.
•8. Use of another investigational product within 30 days prior to receiving the first dose of investigational product.

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