Single&repeat dose of CSJ137 in anaemic chronic haemodialysis patients
Research type
Research Study
Full title
A first-in-human, two-part (open label, and randomised/double blind/placebo controlled), single-and repeat-dose study of CSJ137 in erythropoietin-treated chronic haemodialysis patients with functional iron-deficiency anaemia.
IRAS ID
225232
Contact name
Debasish Banerjee
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2017-002926-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
The purpose of this study is to evaluate whether CSJ137 is an effective and safe drug to warrant further clinical development in anaemia associated with chronic kidney disease. Up to one third of chronic haemodialysis patients do not respond adequately to current treatment. The goal of CSJ137 therapy is that it will allow the body to better use the iron it already has, in order to increase haemoglobin (protein in the blood that helps transport oxygen) levels and improve anaemia.
There are two parts to the study; Part 1 which is a first-in-human, open-label, dose finding study to establish the minimum pharmacologically active dose (PAD) (minimum dose required to induce the required response). It will be comprised of 6 cohorts of 3-6 participants per cohort, with each participant receiving a single dose of antibody CSJ137. Once the minimum PAD has been established, an additional 2 cohorts may be added in order collate additional data. Both the participant and investigator site will be aware of the dose administered. To date, Cohorts 1 and 2 have been completed with a total of 11 patients dosed. The study is now recruiting into Cohort 3.
Part 2 is a randomised, placebo-controlled study where participants will be randomly assigned to either the minimum dose identified in Part 1 or placebo (dummy drug with no active medicine inside). Participants may receive up to 2 doses of study drug during this part of the trial. Subject's participation in Part 1 will last up to maximum of 115 days and in Part 2 135 days.
The study is sponsored by Novartis Pharma AG and will be run in Israel, UK and USA. Additional countries in Europe may be added. Up to 4 sites in the UK will run the study, with the aim to enrol 11 patients.REC name
South Central - Oxford C Research Ethics Committee
REC reference
17/SC/0618
Date of REC Opinion
30 Nov 2017
REC opinion
Favourable Opinion