Phase III Paediatric CKD study in peritoneal dialysis or haemodialysis
Research type
Research Study
Full title
A Phase 3, Open-Label, Multicenter Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 with Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
IRAS ID
136985
Contact name
Nicholas Webb
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2013-002610-13
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 help 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 untreated. In children, this can mean problems with growth and bone formation.
Paricalcitol is a drug shown to lower PTH levels in adults with less of a chance of upsetting the balance of calcium and phosphate compared to some other treatments. This study will look at the safety of paricalcitol in children aged 10-16 with severe CKD who are receiving dialysis. Paricalcitol will be given as oral capsules in this study.
Potential subjects will undergo a number of procedures to determine eligibility for the study. Subjects may have to undergo a washout period if they are currently on a similar medication (to ensure no medication remains in their system) prior to taking paricalcitol. This may last from 2-12 weeks. Eligible subjects will be given paricalcitol at Day 1 and will remain on this for up to 12 weeks.
Subjects will attend the hospital for study visits at Screening, washout visits (if required), Day 1 and every 2-4 weeks for 12 weeks. The effect of the treatment will be checked by blood tests, recording ongoing medical history and completing questionnaires.
This research is funded by AbbVie.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/0116
Date of REC Opinion
30 Apr 2014
REC opinion
Further Information Favourable Opinion