Lexaptepid Pegol (NOX-H94) in ESA-hyporesponsive Anemia in Dialysis Patients
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
2 other identifiers
interventional
33
3 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2014
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2014
CompletedFirst Posted
Study publicly available on registry
March 6, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedNovember 24, 2015
November 1, 2015
1.5 years
February 28, 2014
November 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of adverse events
up to 8 weeks
Secondary Outcomes (3)
Pharmacokinetics
Weeks 1, 2, 3, 4, 5, 6, 8
Pharmacodynamics
0 to 48 hours
Efficacy
Weeks 1, 2, 3, 4, 5, 6, 8
Study Arms (3)
Single dose cross-over pilot
EXPERIMENTALSingle dose of lexaptepid pegol (NOX-H94) cross-over with single dose of placebo
Control
PLACEBO COMPARATORTwice weekly doses of placebo, 9 total
Lexaptepid pegol (NOX-H94)
EXPERIMENTALTwice weekly doses of lexaptepid pegol (NOX-H94), 9 total
Interventions
anti-hepcidin L-RNA-aptamer (Spiegelmer)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TME Pharma AGlead
Study Sites (10)
Dialysis Unit
Düsseldorf, Germany
University Hospital
Halle, Germany
Hospital
Leipzig, Germany
Dialysis Unit
Villingen-Schwenningen, Germany
Hospital
Siena, Italy
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
Related Publications (1)
Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
PMID: 30957581DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kai Riecke, MD
TME Pharma AG
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2014
First Posted
March 6, 2014
Study Start
May 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
November 24, 2015
Record last verified: 2015-11