A facilitated access study for SBR759 in patients with renal failure

• Research type

  Research Study

• Full title

  A facilitated access open-label, non-randomized, multicenter, long-term safety and efficacy study in Chronic Kidney Disease patients treated with SBR759 who have completed previous SBR759 studies

• IRAS ID

  28192

• Eudract number

  2009-011007-23

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this study (SBR759 2305) is to allow patients who have completed 12 months of treatment with SBR in a previous clinical trial (SBR759 2201) to continue to receive treatment with SBR until the drug is licensed for use in the UK, or until the programme is discontinued, while also allowing Novartis to continue to collect safety data on SBR759. The study is an open-label, non-randomized design where patients will continue on their currently assigned dose from the previous SBR759 study.Patients with Kidney Disease often experience high levels of phosphate in their blood. Serum phosphate has an important role in mineral and bone metabolism disorders. These high levels of phosphate can cause an increase in bone degradation and hardening of the arteries. In the long term this can lead to an increased risk of cardiovascular disease and cardiovascular related death. SBR759 is a new phosphate binder which is not absorbed and is designed to specifically bind phosphate in the gastrointestinal tract. Suitable patients will be on regular dialysis and have been receiving SBR for 12 months in the SBR 759 2201 study. If they choose to take part, they will have quarterly study visits that coincide with their normal dialysis sessions.The study is being sponsored by Novartis pharmaceuticals and will be run in Dialysis clinics in the UK.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  09/H0606/93

• Date of REC Opinion

  4 Sep 2009

• REC opinion

  Favourable Opinion