Estudio abierto de 3 partes para evaluar la farmacocinética del carbonato de lantano, comparar la eficacia, seguridad y tolerabilidad de 8 semanas de tratamiento con carbonato de lantano y carbonato de calcio mediante un diseño cruzado, e investigar la eficacia y seguridad de 8 meses de tratamiento con carbonato de lantano en niños y adolescentes hiperfosfatémicos de 10 a menos de 18 años con enfermedad renal crónica en diálisis

CompletadoFase 2ClinicalTrials.gov

ID: NCT01696279Tipo: INTERVENTIONALInicio: 15 de feb de 2013Fin estimado: 16 de nov de 2018

Resumen

El propósito de este estudio es resumir el porcentaje de participantes que alcanzan los objetivos de fósforo sérico específicos por edad de la Iniciativa de Calidad de Resultados en Enfermedad Renal (KDOQI) en niños y adolescentes hiperfosfatémicos con enfermedad renal crónica (ERC) en diálisis, después de 8 semanas de tratamiento con carbonato de lantano.

Elegibilidad

Edad mínima: 10 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Aged 10 years to less than (\<) 18 years of age at the time of consent.
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.
Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.
Established chronic kidney disease (CKD), on dialysis, and requires treatment for hyperphosphatemia with a phosphate binder.
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).
Ability to provide written, signed and dated (personally or via an LAR) informed consent/and assent, as applicable, to participate in the study.

Criterios de exclusión

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

Intervenciones

drug

Lanthanum Carbonate

Lanthanum Carbonate 1500 mg to 3000 mg powder will be administered orally.

drug

Calcium Carbonate

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.

Ubicaciones

Centro Infantil Del Rinon S.R.L

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalShire

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