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

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ClinicalTrials.gov Identifier: NCT02079896
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : November 24, 2015
Sponsor:
Information provided by (Responsible Party):
NOXXON Pharma AG

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Anemia End Stage Renal Disease Drug: Lexaptepid pegol (NOX-H94) Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Dialysis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single dose cross-over pilot
Single dose of lexaptepid pegol (NOX-H94) cross-over with single dose of placebo
 Drug: Lexaptepid pegol (NOX-H94)
anti-hepcidin L-RNA-aptamer (Spiegelmer)
Other Name: NOX-H94

Drug: Placebo
Placebo Comparator: Control
Twice weekly doses of placebo, 9 total
 Drug: Placebo
Experimental: Lexaptepid pegol (NOX-H94)
Twice weekly doses of lexaptepid pegol (NOX-H94), 9 total
 Drug: Lexaptepid pegol (NOX-H94)
anti-hepcidin L-RNA-aptamer (Spiegelmer)
Other Name: NOX-H94


Outcome Measures
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Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: up to 8 weeks ]

Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079896


Locations
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Germany
Dialysis Unit
Düsseldorf, Germany
University Hospital
Halle, Germany
Hospital
Leipzig, Germany
Dialysis Unit
Villingen-Schwenningen, Germany
Italy
Hospital
Siena, Italy
United Kingdom
Hospital
Swansea, Wales, United Kingdom
Hospital
Leicester, United Kingdom
Hospital
London, United Kingdom
King's College London
London, United Kingdom
Lister Hospital
Stevenage, United Kingdom
Sponsors and Collaborators
NOXXON Pharma AG
Investigators
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Study Director: Kai Riecke, MD NOXXON Pharma AG
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NOXXON Pharma AG
ClinicalTrials.gov Identifier: NCT02079896    
Other Study ID Numbers: SNOXH94C301
2013-003585-14 ( EudraCT Number )
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2015
Keywords provided by NOXXON Pharma AG:
Dialysis
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Anemia
Hematologic Diseases
Kidney Diseases
 Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency