MCI-196-E14 Colestilan vs Standard Therapy in children with stage5 CKD

• Research type

  Research Study

• Full title

  A Multi-centre, Randomised, Controlled, Parallel Group, Open-label Study Evaluating the Efficacy, Safety and Tolerability of Three Doses of Colestilan (MCI-196) Compared to Standard Therapy with a Calcium-based Phosphate Binder, in Paediatric Subjects with Chronic Kidney Disease Stage 5 on Dialysis and with Hyperphosphataemia

• IRAS ID

  122492

• Contact name

  Lesley Rees

• Sponsor organisation

  Mitsubishi Tanabe Pharma Corporation (MTPC)

• Eudract number

  2012-002581-12

• Research summary

  Hyperphosphataemia occurs in response to decreased excretion of phosphorus (P) associated with progressive loss of renal function. In general, the incidence of hyperphosphataemia correlates with the progression of chronic kidney disease (CKD) and almost all patients with CKD stage 5 will have hyperphosphataemia unless steps are taken to control P levels. It has been known for many years that hyperphosphataemia leads to an increase in mortality in adults. The increased mortality may be related to secondary disease, including calcification of the heart vasculature, as well as non-vascular calcification, for example of the lungs. Evidence of cardiac calcification has been found in 20% of children with CKD stage 5. Colestilan (MCI-196) is absorbs P in the gastrointestinal (GI) tract. The absorption of P enables colestilan to be considered as a potential agent for the treatment of hyperphosphataemia in CKD patients, both adults and children.The aims of this study are: - To determine the initial starting doses of colestilan (MCI-196) in paediatric subjects (children aged 2 to 17).- To assess the short-term efficacy of colestilan (MCI-196) compared to standard therapy in paediatric subjects- To evaluate the short-term safety of colestilan (MCI-196) compared to standard therapy in paediatric subjects.This study plans to enrol approximately 140 evaluable subjects with at least 35 subjects randomised to each of the following four treatment arms:?½colestilan at an adapted adult daily dose (AADD) of 3 g/day ?½colestilan AADD 6 g/day ?½colestilan AADD 9g/day?½standard therapy with calcium-based P-binders (CBPB)The total study duration will be up to 25 weeks.Study visits are scheduled during the treatment period at Weeks 0 (baseline), 3, 6, 9, 13, and 17. Assessments will include physical examinations, vital signs, evaluation of nutritional status, growth measurement, ECGs and blood tests. Each child and/or parent/guardian will be required to complete a journal for the duration of the study.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  13/YH/0020

• Date of REC Opinion

  14 Mar 2013

• REC opinion

  Further Information Favourable Opinion