Paricalcitol for Secondary Hyperparathyroidism in Pediatric Kidney Disease
Trial Summary
What is the purpose of this trial?
This trial is testing a medication called paricalcitol, which is taken by mouth, in young children with severe kidney disease and hormone imbalance. The goal is to see if it is safe and effective in balancing their hormone levels. Paricalcitol has been shown to be effective in reducing calcium and phosphorus levels in patients with kidney issues.
Do I have to stop taking my current medications for the trial?
The trial requires a washout period for participants who are not new to vitamin D receptor activators (VDRA). You must stop taking certain medications like calcitonin, bisphosphonates, and high doses of glucocorticoids 4 weeks before dosing. You also cannot take calcimimetics during the study.
What data supports the idea that Paricalcitol for Secondary Hyperparathyroidism in Pediatric Kidney Disease is an effective drug?
The available research shows that Paricalcitol effectively reduces high levels of parathyroid hormone (PTH) in children with secondary hyperparathyroidism due to chronic kidney disease. It is as effective as another drug called calcitriol and is generally well tolerated, meaning it doesn't cause many side effects. One study highlighted that Paricalcitol led to a significant decrease in PTH levels in children aged 10-16, with minimal adverse effects. Additionally, Paricalcitol has been shown to improve survival rates in dialysis patients compared to calcitriol. This makes it a useful option for managing this condition in children.12345
What safety data exists for paricalcitol in treating secondary hyperparathyroidism in children with kidney disease?
Paricalcitol, also known as Zemplar, is a synthetic vitamin D2 analog used to treat secondary hyperparathyroidism in children with chronic kidney disease. Clinical trials have shown that paricalcitol effectively reduces elevated parathyroid hormone (PTH) levels and is generally well tolerated in both children and adults. It has a lower incidence of prolonged hypercalcemia compared to calcitriol. Studies have reported minimal adverse events in children aged 10-16 years, indicating its safety and efficacy. However, more research is needed, especially for younger children, to further establish its safety profile.12346
Is the drug Paricalcitol a promising treatment for secondary hyperparathyroidism in children with kidney disease?
Yes, Paricalcitol is a promising drug for treating secondary hyperparathyroidism in children with kidney disease. It effectively reduces high levels of parathyroid hormone, is well-tolerated, and has fewer side effects compared to other treatments. It also helps protect the kidneys and heart, making it a valuable option for managing this condition.12367
Research Team
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
This trial is for children aged 0-9 with stage 5 chronic kidney disease on dialysis, who have secondary hyperparathyroidism. They must meet specific lab criteria and have been on dialysis for at least a month. Kids can't join if they're getting a kidney transplant soon, had parathyroid surgery recently, can't take oral meds, or are on certain bone-related treatments.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dosing Period 1
Participants receive paricalcitol oral solution three times a week for 12 weeks
Dosing Period 2
Continuation of paricalcitol oral solution treatment for an additional 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Paricalcitol (Vitamin D Analog)
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor