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.

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 100

Inclusion Criteria

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: 100
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

Exclusion Criteria

Subjects are excluded from the study if any of the following criteria are
met:
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
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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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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