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Completed

NCT Number: NCT02079896

Lexaptepid Pegol (NOX-H94) in ESA-hyporesponsive Anemia in Dialysis Patients

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.

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Key information

Conditions

Anemia Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dialysis Unit, Düsseldorf, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • End stage renal disease treated with maintenance hemodialysis.
  • Anemia : Hb 7 to 11 g/dL.
  • Functional iron deficiency: Transferrin saturation <30%, Ferritin ≥300 ng/mL.
  • ESA-hyporesponsiveness with erythropoietin dose ≥12,000 IU/ week.

Exclusion criteria

  • Treatment with darbepoetin or methoxy-polyethyleneglycol-epoetin.
  • Uncontrolled / unstable cardiovascular , peripheral arterial or cerebrovascular disease.
  • Congestive heart failure: New York Heart Association Class III or IV.
  • Unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty/stents, or coronary artery bypass grafting <3 months prior screening.
  • Any other medical conditions requiring a change in treatment within 4 weeks prior to screening or making study participation unadvisable.
  • History of clinically relevant hemolysis and/or blood loss.
  • AST, ALT, or bilirubin ≥2.0 times the upper limit of normal.
  • Known bone marrow fibrosis.
  • Treatment with i.v. iron <4 weeks prior to screening or during the screening period or change in erythropoietin dose during last month.
  • Any acute or chronic infection, viral or bacterial within 4 weeks prior to screening or during the screening period considered as systemic infection.

Treatment and study plan

Lexaptepid pegol (NOX-H94)

Drug

anti-hepcidin L-RNA-aptamer (Spiegelmer)

Other names: NOX-H94

Placebo

Drug

Primary outcomes

  1. Number of adverse events

    Time frame: up to 8 weeks

Secondary outcomes

  1. Pharmacokinetics

    Time frame: Weeks 1, 2, 3, 4, 5, 6, 8

    Peak concentrations, systemic exposure, elimination

  2. Pharmacodynamics

    Time frame: 0 to 48 hours

    Change in serum iron concentrations

  3. Efficacy

    Time frame: Weeks 1, 2, 3, 4, 5, 6, 8

    Change in hemoglobin

Sponsors and collaborators

Lead sponsor

TME Pharma AG

Industry

Registry information

Official study title

Safety, PK/PD, and Efficacy of NOX-H94 in Dialysis Patients With ESA-hyporesponsive Anemia: A Randomized, Double Blind, Placebo Controlled Parallel Group Study With a Single Blind Cross-over Group

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 6, 2014
Registry last updated
Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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