Observational Study to Evaluate the Safety and Efficacy of Kremezin IDT/Fine Gran in Progressive Chronic Kidney Disease Patients.
Chronic Kidney Disease
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 19 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 3125 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Población del estudio
3125
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Proportion of participants with an effective overall assessment at Week 24
Plazo: Baseline to Week 24 (Week 24 ±3 weeks)
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.
Medidas secundarias
Proportion of participants with an effective overall assessment at Week 48
Plazo: Baseline to Week 48 (Week 48 ±4 weeks)
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.
Change from baseline in serum creatinine (Scr) at Weeks 24 and 48
Plazo: Baseline to Week 24 and Week 48
Change = Scr at Week 24 or Week 48 - Scr at baseline.
Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 24 and 48
Plazo: Baseline to Week 24 and Week 48
eGFR will be calculated using the CKD-EPI equation. Change = eGFR at Week 24 or Week 48 - eGFR at baseline.
Mean treatment satisfaction score at Weeks 24 and 48
Plazo: Week 24 and Week 48
Treatment satisfaction will be assessed on a 7-point scale, from 1 (extremely dissatisfied) to 7 (extremely satisfied).
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
HK inno.NSeoul, South KoreaReclutando
Equipo y fechas
- Patrocinador principal
- HK inno.N Corporation
- Inicio del estudio
- 18 jul 2023 Real
- Finalización primaria
- 31 dic 2027 Estimado
- Finalización del estudio
- 31 dic 2027 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Multi-center, Prospective, Observational Study to Evaluate the Safety and Efficacy of Kremezin IDT/Fine Gran in Progressive Chronic Kidney Disease Patients.
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026