A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis
Condition: Chronic Kidney Disease; Hyperphosphatemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Intervention: Lanthanum Carbonate; Calcium Carbonate
Intervention description: Lanthanum Carbonate 1500 mg to 3000 mg powder will be administered orally.; Calcium carbonate will be administered orally at a total daily dose based on standard clinical practice. The total daily dose may be adjusted as appropriate, until the target serum phosphorus level is achieved or until a maximum daily dose of 6500 mg is reached.
Intervention MeSH terms: Calcium Carbonate; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to summarize the percentage of participants achieving
      age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus
      in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on
      dialysis, following 8 weeks of treatment with lanthanum carbonate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged 10 years to less than (<) 18 years of age at the time of consent.

          2. Participant or parent/legally authorized 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 chronic kidney disease (CKD), on dialysis, and requires treatment for
             hyperphosphatemia with a phosphate binder.

          5. Serum phosphorus levels after a washout period of up to 3 weeks as follows: Age <12
             years: Serum phosphorus greater than (>) 6.0 mg/dL (1.94 mmol/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.

        Exclusion Criteria:

          1. Current or recurrent disease (example [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 participant 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 participant are outside of local applicable criteria for blood
             sample volume limits.

          8. Use of another investigational product within 30 days prior to receiving the first
             dose of investigational product.