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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079896
• Other study ID #: SNOXH94C301
• Secondary ID: 2013-003585-14
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 28, 2014
• Last updated: November 23, 2015
• Start date: May 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: NOXXON Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Lexaptepid pegol (NOX-H94)
anti-hepcidin L-RNA-aptamer (Spiegelmer)
• Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
NOXXON Pharma AG

Countries where clinical trial is conducted

Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		up to 8 weeks	Yes
Secondary	Pharmacokinetics	Peak concentrations, systemic exposure, elimination	Weeks 1, 2, 3, 4, 5, 6, 8	Yes
Secondary	Pharmacodynamics	Change in serum iron concentrations	0 to 48 hours	No
Secondary	Efficacy	Change in hemoglobin	Weeks 1, 2, 3, 4, 5, 6, 8	No