MCI-196-E16 Colestilan in children with stage 3b-5 CKD not on dialysis

• Research type

  Research Study

• Full title

  A Multi-centre, Open-label Study Evaluating the Safety and Tolerability of Colestilan (MCI 196) in Paediatric Subjects with Chronic Kidney Disease Stages 3b to 5 and with Hyperphosphataemia not on Dialysis

• IRAS ID

  122864

• Contact name

  Lesley Rees

• Sponsor organisation

  Mitsubishi Tanabe Pharma Corporation (MTPC)

• Eudract number

  2012-002582-35

• 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. Whilst it is widely recognised that a majority of patients with CKD stage 5 suffer from hyperphosphataemia, it is also true that hyperphosphataemia is prevalent in earlier stages of CKD, such as 3b and 4.4 Therefore there is an unmet need for treatment of hyperphosphataemia in this patient population.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 aim of this study is to assess the safety and tolerability of colestilan in paediatric subjects(aged 2 years to <18 years) with CKD stages 3b to 5, diagnosed with hyperphosphataemia, who are not on dialysis- To assess the short-term efficacy of colestilan (MCI-196) compared to standard therapy in paediatric subjects.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  13/YH/0021

• Date of REC Opinion

  14 Mar 2013

• REC opinion

  Further Information Favourable Opinion