Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
KIND
Phase 3 study for the treatment of Secondary Hyperparathyroidism (SHPT) in pediatric subjects with stage 5 Chronic Kidney Disease (CKD).
Brief Description
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).
Trial Physician / Study Coordinator
Jessica Timmer
Email PhoneSite Name
Holtz Childrens Hospital, University of Miami
1580 NW 10th Ave, Room 542 Miami FL 33136-1013
Sponsor
Abbvie
Study Drug
Paricalcitol
Estimated enrollment
16 patients
Estimated end date
February 2027
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
KIND
Phase 3 study for the treatment of Secondary Hyperparathyroidism (SHPT) in pediatric subjects with stage 5 Chronic Kidney Disease (CKD).
Brief Description
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).
Trial is for people with
2-9 years old patients diagnosed with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) stage 5 receiving peritoneal dialysis (PD) or hemodialysis (HD).
Study Goal
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).
What is involved for the Patient?
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks.
About the drug or intervention
Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser.