PIVOTAL

• Research type

  Research Study

• Full title

  UK Multicentre Open-label Randomised Controlled Trial Of IV Iron Therapy In Incident Haemodialysis Patients

• IRAS ID

  111572

• Contact name

  Iain Macdougall

• Contact email

  iain.macdougall@nhs.net

• Sponsor organisation

  King's College Hospital NHS Foundation Trust

• Eudract number

  2013-002267-25

• ISRCTN Number

  Not provided

• Clinicaltrials.gov Identifier

  Not provided

• Research summary

  There is clinical equipoise regarding the use of liberal amounts of IV iron in Chronic Kidney Disease (CKD) patients. There is therefore a need for a clinical trial to test the efficacy and safety of high-dose IV iron supplementation in this patient population.

  This is a large multicentre study where patients with CKD requiring dialysis, will be allocated to receive either a high dose of intravenous iron or standard low dose of iron.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  13/LO/1115

• Date of REC Opinion

  6 Sep 2013

• REC opinion

  Further Information Favourable Opinion