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

November 23, 2015 updated by: TME Pharma AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany
        • Dialysis Unit
      • Halle, Germany
        • University Hospital
      • Leipzig, Germany
        • Hospital
      • Villingen-Schwenningen, Germany
        • Dialysis Unit
  • Italy
      • Siena, Italy
        • Hospital
  • United Kingdom
      • Leicester, United Kingdom
        • Hospital
      • London, United Kingdom
        • King's College London
      • London, United Kingdom
        • Hospital
      • Stevenage, United Kingdom
        • Lister Hospital
    • Wales
      • Swansea, Wales, United Kingdom
        • Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Single dose cross-over pilot
Single dose of lexaptepid pegol (NOX-H94) cross-over with single dose of placebo
Drug: Placebo
Drug: Lexaptepid pegol (NOX-H94)
anti-hepcidin L-RNA-aptamer (Spiegelmer)
Other Names:
  • NOX-H94
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 Names:
  • NOX-H94

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events
Time Frame: up to 8 weeks
up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics
Time Frame: Weeks 1, 2, 3, 4, 5, 6, 8
Peak concentrations, systemic exposure, elimination
Weeks 1, 2, 3, 4, 5, 6, 8
Pharmacodynamics
Time Frame: 0 to 48 hours
Change in serum iron concentrations
0 to 48 hours
Efficacy
Time Frame: Weeks 1, 2, 3, 4, 5, 6, 8
Change in hemoglobin
Weeks 1, 2, 3, 4, 5, 6, 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TME Pharma AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

February 28, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (ESTIMATE)

March 6, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 24, 2015

Last Update Submitted That Met QC Criteria

November 23, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNOXH94C301
  • 2013-003585-14 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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