NOX-H94 in ESA-hyporesponsive anaemia in dialysis patients V2.0
Research type
Research Study
Full title
Safety, PK/PD and efficacy of NOX-H94 in dialysis patients with ESA-hyporesponsive anaemia: A randomized, double blind, placebo controlled parallel group study with a single blind cross-over group
IRAS ID
140066
Contact name
Iain MacDougall
Contact email
Sponsor organisation
NOXXON Pharma AG
Eudract number
2013-003585-14
Research summary
This is a multi-centre, phase IIa study in patients with ESA hyporesponsive anaemia, iron deficiency and end stage renal disease treated with haemodialysis.
The study drug is called NOX-H94, an anti-Hepcidin therapy that is currently unlicensed.
A total of 20 patients will take part in the study at up to three sites in the United Kingdom. The study is composed of two consecutive parts: First part, where 8 patients will receive a single treatment of NOX-H94 and placebo in a single blind cross-over design and a second part, where 12 patients will be treated with repeated doses of NOX-H94 and placebo in a randomised double-blind parallel group design. The i.v. administration of the study medication will be done by slow injection over 1 minute into the venous line of the dialyser.
In part I, the safety, the elimination and the activity of NOX-H94 after single administration of 1,2 mg/kg will be studied over two treatments in group 1, followed up by 5 clinic visits over 26 days.
A Drug Safety Board will review the safety and PK data from study group 1 to give a recommendation on the subsequent treatment in groups 2/3.
In part II, patients will receive either NOX-H94 or placebo decided by a previously established random process. Patients, participating in groups 2 or 3 will receive nine doses of NOX-H94 or placebo to study the safety, the elimination, the activity of NOX-H94 after repeated doses and first signs of efficacy on haemoglobin, followed up by 3 clinic visits over 26 days.
REC name
London - London Bridge Research Ethics Committee
REC reference
13/LO/1714
Date of REC Opinion
10 Jan 2014
REC opinion
Further Information Favourable Opinion