MCI-196-E15 Extension Study Evaluating Colestilan

• Research type

  Research Study

• Full title

  A Multi-centre, Flexible Dose, Parallel Group, Open-label, Active Control (Calcium based Phosphate Binder), Long-term Extension Study Evaluating the Efficacy, Safety and Tolerability of Colestilan (MCI-196) in Paediatric Subjects With Hyperphosphataemia and With Either Chronic Kidney Disease Stage 5 on Dialysis or Chronic Kidney Disease Stages 3b to 5 Not on Dialysis

• IRAS ID

  123013

• Contact name

  Lesley Rees

• Sponsor organisation

  Mitsubishi Tanabe Pharma Corporation (MTPC)

• Eudract number

  2012-002583-27

• 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. Phosphate binders are necessary to limit dietary absorption of P. While it is widely recognised that a majority of patients with CKD stage 5 suffer from hyperphosphataemia, it is also recognized that hyperphosphataemia is prevalent in earlier stages of CKD, such as 3b and 4. Therefore, there is an unmet need for treatment of hyperphosphataemia in both of these patient populations.Colestilan (MCI-196) 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 assess the long-term efficacy of treatment with colestilan (MCI-196) (including combination therapy)- To assess the long-term safety of treatment with colestilan (MCI-196) (including combination therapy).The endeavour of this study is to enrol as many eligible subjects from the short-term studies (i.e., MCI-196-E14 and MCI 196 E16) as possible. All subjects will be scheduled to receive the study drug up to a total of 52 weeks, which includes the duration of treatment in the short-term study.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  13/YH/0022

• Date of REC Opinion

  14 Mar 2013

• REC opinion

  Further Information Favourable Opinion