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
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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 |
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Anemia End Stage Renal Disease | Drug: Lexaptepid pegol (NOX-H94) Drug: Placebo | Phase 1 Phase 2 |
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 |

Arm | Intervention/treatment |
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Experimental: Single dose cross-over pilot
Single dose of lexaptepid pegol (NOX-H94) cross-over with single dose of placebo
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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
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Drug: Placebo |
Experimental: Lexaptepid pegol (NOX-H94)
Twice weekly doses of lexaptepid pegol (NOX-H94), 9 total
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Drug: Lexaptepid pegol (NOX-H94)
anti-hepcidin L-RNA-aptamer (Spiegelmer)
Other Name: NOX-H94 |
- Number of adverse events [ Time Frame: up to 8 weeks ]
- Pharmacokinetics [ Time Frame: Weeks 1, 2, 3, 4, 5, 6, 8 ]Peak concentrations, systemic exposure, elimination
- Pharmacodynamics [ Time Frame: 0 to 48 hours ]Change in serum iron concentrations
- Efficacy [ Time Frame: Weeks 1, 2, 3, 4, 5, 6, 8 ]Change in hemoglobin

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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 |
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.

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
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 |
Study Director: | Kai Riecke, MD | TME Pharma AG |
Responsible Party: | TME 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 |
Dialysis |
Kidney Failure, Chronic Anemia Hematologic Diseases Kidney Diseases |
Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |