Safety and Efficacy of Paricalcitol in Paediatric Stage 3/4 CKD
Research type
Research Study
Full title
A Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric Subjects Ages 10 to 16 years with Moderate to Severe Chronic Kidney Disease
IRAS ID
53004
Contact name
Nicholas Webb
Sponsor organisation
Abbott GmbH & Co. KG
Eudract number
2010-019439-37
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Chronic Kidney Disease (CKD) is long term damage or disease to the kidneys, which can stop them from working properly. Severity of CKD can range from mild to end stage kidney failure. It is important to detect even mild CKD, as treatment can stop it getting worse.An early and common problem with CKD is Secondary Hyperparathyroidism (SHPT). Parathyroid hormone (PTH) is a substance in the body that helps to keep the right amounts of calcium and phosphate in the blood. SHPT is where there is too much PTH, which also affects the levels of calcium and phosphate. This can lead to serious conditions of the bones and may cause heart problems if left untreated. In children, this can mean problems with growth and bone formation.Paricalcitol is a drug that has been shown to lower PTH levels in adults without upsetting the balance of calcium and phosphate. This study will look at the safety of paricalcitol, and whether the drug works to reduce levels of PTH in children aged 10-16 with moderate to severe CKD. Paricalcitol will be given as oral capsules in this study.Each subject will be screened for entry into the study, which can take 2-14 weeks. Following screening, from Day 1 subjects will receive either paricalcitol or placebo (placebo looks the same as paricalcitol but contains no active drug) for 12 weeks, then all subjects will receive paricalcitol for a further 12 weeks. Subjects will have a follow up telephone call 30 days after finishing treatment.Subjects will attend for study visits in hospital at screening, Day 1 and then every 2-4 weeks for 24 weeks. The effect of the treatment will be checked by having blood tests, urine tests, recording ongoing medical history, and completing questionnaires. This research is being funded by Abbott Laboratories.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
10/H1002/48
Date of REC Opinion
10 Sep 2010
REC opinion
Further Information Favourable Opinion