Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
KIND study
Phase 3 study for the treatment of Secondary Hyperparathyroidism (SHPT) in pediatric subjects with stage 5 Chronic Kidney Disease (CKD).
Breve descripción
The KIND study is testing the safety, efficacy, and pharmacokinetics of paricalcitol oral solution in participants of ages 0 to 9 years that have been diagnosed with Secondary Hyperparathyroidism (SHPT) associated with stage 5 Chronic Kidney Disease (CKD) receiving Peritoneal Dialysis (PD) or Hemodialysis (HD).
Médico del ensayo/Coordinador del estudio
Jessica Timmer
Correo electrónico Número de teléfono 305-243-4304Nombre del sitio
Holtz Childrens Hospital, University of Miami
1580 NW 10th Ave, Room 542 Miami FL 33136-1013
Matrícula estimada
16 patients
Fecha estimada de finalización
February 2027
Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
KIND study
Phase 3 study for the treatment of Secondary Hyperparathyroidism (SHPT) in pediatric subjects with stage 5 Chronic Kidney Disease (CKD).
Breve descripción
The KIND study is testing the safety, efficacy, and pharmacokinetics of paricalcitol oral solution in participants of ages 0 to 9 years that have been diagnosed with Secondary Hyperparathyroidism (SHPT) associated with stage 5 Chronic Kidney Disease (CKD) receiving Peritoneal Dialysis (PD) or Hemodialysis (HD).
El ensayo es para personas con
2-9 years old patients diagnosed with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) stage 5 receiving peritoneal dialysis (PD) or hemodialysis (HD).
Objetivo del estudio
The goal of the study is to assess the effect of Paracalcitol on blood calcium levels and intact parathyroid hormone (iPTH) in pediatric patients with Secondary Hyperparathyroidism (SHPT) associated with stage 5 Chronic Kidney Disease (CKD).
Qué implica para el paciente?
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks.
Sobre el medicamento o la intervención
Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser.