A Phase 1/2 interventional study of Lexaptepid pegol (NOX-H94) and Placebo in Anemia and End Stage Renal Disease, sponsored by TME Pharma AG. Completed at 10 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-11-24.
Sponsored by TME Pharma AG · Phase 1/2, Interventional, and Treatment
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 33 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →TME Pharma AG is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Single dose of lexaptepid pegol (NOX-H94) cross-over with single dose of placebo
Drug: Lexaptepid pegol (NOX-H94) · Drug: Placebo
Twice weekly doses of placebo, 9 total
Drug: Placebo
Twice weekly doses of lexaptepid pegol (NOX-H94), 9 total
Drug: Lexaptepid pegol (NOX-H94)
anti-hepcidin L-RNA-aptamer (Spiegelmer)
Also known as: NOX-H94
Number of adverse events
Time frame: up to 8 weeks
Pharmacokinetics
Peak concentrations, systemic exposure, elimination
Time frame: Weeks 1, 2, 3, 4, 5, 6, 8
Pharmacodynamics
Change in serum iron concentrations
Time frame: 0 to 48 hours
Efficacy
Change in hemoglobin
Time frame: Weeks 1, 2, 3, 4, 5, 6, 8
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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TME Pharma AG