Observational Study to Evaluate the Safety and Efficacy of Kremezin IDT/Fine Gran in Progressive Chronic Kidney Disease Patients.
A Multi-center, Prospective, Observational Study to Evaluate the Safety and Efficacy of Kremezin IDT/Fine Gran in Progressive Chronic Kidney Disease Patients.
This study will be conducted under routine clinical practice in adults diagnosed with advanced chronic renal failure for whom treatment with Kremezin immediate-release tablets or Kremezin fine granules has been determined as part of standard clinical care. Kremezin will be prescribed and administered in accordance with the approved product labeling. Study data will be collected at up to three time points through Week 48: baseline, Week 24, and Week 48. Effectiveness will be assessed using serum creatinine (Scr), estimated glomerular filtration rate (eGFR), and the investigator's overall assessment; treatment satisfaction and safety information will also be collected.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This is a multicenter, prospective, observational study to evaluate the effectiveness and safety of Kremezin immediate-release tablets or Kremezin fine granules in adults diagnosed with advanced chronic renal failure. During routine clinical visits, the investigator will determine whether Kremezin treatment is appropriate. The investigator will prescribe the selected formulation in accordance with the product labeling and routine clinical practice. The treatment decision must be made before the participant provides consent to participate in the study and without any study-related intervention.
Adults will receive Kremezin immediate-release tablets or fine granules at the approved dosage-2 g three times daily (4 tablets per dose or 1 sachet per dose, respectively)-for the treatment period determined in routine care, with study data collected through Week 48. Scr and eGFR will be recorded at baseline, Week 24 (±3 weeks), and Week 48 (±4 weeks). At Weeks 24 and 48, the investigator will also assess overall effectiveness and treatment satisfaction and collect safety information. Blood pressure and laboratory results will be collected when available. The study will not require additional treatment or visits beyond routine clinical care.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yongan Jeong
- Número de teléfono: +82-31-5176-4673
- Correo electrónico: yongan.jeong@inno-n.com
Copia de seguridad de contactos de estudio
- Nombre: Nayoung Lee
- Número de teléfono: +82-31-5176-4675
- Correo electrónico: nayoung.lee1@inno-n.com
Ubicaciones de estudio
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Seoul, Corea del Sur
- Reclutamiento
- HK inno.N
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Contacto:
- Ahrong Kim
- Número de teléfono: +82-31-5176-4666
- Correo electrónico: ahrong.kim@inno-n.com
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Contacto:
- Nayoung Lee
- Número de teléfono: +82-31-5176-4675
- Correo electrónico: nayoung.lee1@inno-n.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
3125
Descripción
Inclusion Criteria:
- Adults aged 19 years or older diagnosed with advanced chronic renal failure.
- Individuals who voluntarily decide to participate and provide written informed consent.
Exclusion Criteria:
- Individuals for whom Kremezin immediate-release tablets or Kremezin fine granules are contraindicated according to the product labeling.
- Individuals with AST or ALT levels at least three times the upper limit of normal.
- Individuals with chronic alcoholism.
- Individuals with an active or progressive infection.
- Pregnant or breastfeeding individuals.
- Individuals with a history of dialysis.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: OTHER
- Perspectivas temporales: PROSPECTIVE
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Proportion of participants with an effective overall assessment at Week 24
Periodo de tiempo: Baseline to Week 24 (Week 24 ±3 weeks)
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Overall effectiveness will be assessed by the investigator based on serum creatinine (Scr) and estimated glomerular filtration rate (eGFR). Participants will be classified as effective, ineffective, or unevaluable; unevaluable participants will be excluded from the analysis. |
Baseline to Week 24 (Week 24 ±3 weeks)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of participants with an effective overall assessment at Week 48
Periodo de tiempo: Baseline to Week 48 (Week 48 ±4 weeks)
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Overall effectiveness will be assessed by the investigator based on Scr and eGFR. Participants will be classified as effective, ineffective, or unevaluable; unevaluable participants will be excluded from the analysis. |
Baseline to Week 48 (Week 48 ±4 weeks)
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Change from baseline in serum creatinine (Scr) at Weeks 24 and 48
Periodo de tiempo: Baseline to Week 24 and Week 48
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Change = Scr at Week 24 or Week 48 - Scr at baseline. |
Baseline to Week 24 and Week 48
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Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 24 and 48
Periodo de tiempo: Baseline to Week 24 and Week 48
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eGFR will be calculated using the CKD-EPI equation. Change = eGFR at Week 24 or Week 48 - eGFR at baseline. |
Baseline to Week 24 and Week 48
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Mean treatment satisfaction score at Weeks 24 and 48
Periodo de tiempo: Week 24 and Week 48
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Treatment satisfaction will be assessed on a 7-point scale, from 1 (extremely dissatisfied) to 7 (extremely satisfied). |
Week 24 and Week 48
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedad crónica
- Atributos de la enfermedad
- Insuficiencia renal
- Condiciones Patológicas, Signos y Síntomas
- Insuficiencia Renal Crónica
Otros números de identificación del estudio
- IN_KRM_N01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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