Lexaptepid Pegol (NOX-H94) in ESA-hyporesponsive Anemia in Dialysis Patients
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
Dialysis patients regularly suffer from anemia which may be caused by various contributing
factors, alone or in combination, including blood loss, low erythropoietin and iron
sequestration. In most patients, the anemia is responsive to treatment with erythropoietin or
other erythropoiesis stimulating agents (ESA) alone or in combination with intravenous (i.v.)
iron. In about 10% of patients however, the anaemia does not respond appropriately to this
standard treatment and high to very high doses of ESA and i.v. iron are used to maintain
acceptable hemoglobin concentrations. In these patients, hepcidin was identified as a
causative factor leading to anemia of chronic disease with functional iron deficiency and
ESA-hyporesponsiveness.
The Spiegelmer lexaptepid pegol (NOX-H94) offers a hepcidin-specific approach to the
treatment of anemia of chronic disease. The safety and the activity of lexaptepid pegol are
supported by data from healthy subjects and patients with multiple myeloma or lymphoma. The
present study in dialysis patients with functional iron deficiency and ESA-hyporesponsiveness
is conducted to demonstrate the safety of lexaptepid pegol in this population, to investigate
its pharmacokinetic (PK) and pharmacodynamic (PD) profiles and its efficacy in increasing
haemoglobin (Hb) in dialysis patients.