ot applicable

• Conditions: anemia associated with chronic kidney disease in pre-dialysis and dialysis patients; MedDRA version: 14.1Level: LLTClassification code 10058124Term: Nephrogenic anemiaSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-002871-40-PL
• Lead Sponsor: Hexal AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-16
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Adult patients with CKD induced anemia, with or without dialysis
treatment, requiring ESA therapy
• Patients with anemia, defined as mean Hb level less than or equal to
11.0 g/dL, for patients naïve to ESA therapy or between 9.0 g/dL and
12.0 g/dL for patients receiving ESA therapy, based on at least 2 Hb
measurements during the 4-week screening period
• Patients who are not naïve to ESA therapy should be receiving stable
i.v. or s.c. maintenance therapy with an European Union (EU)-approved ESA (stable defined as = 30% change in weekly dose during screening) corresponding to a maximum weekly dose of 300 IU/kg or equivalent, and in accordance with the relevant prescribing information
• Adequate iron substitution status defined as serum ferritin =200 µg/L
and =800 µg/L for patients on dialysis and serum ferritin = 100 µg/L and = 800 µg/L for patients not on dialysis, and transferrin saturation = 20% and =50% (confirmed by a sample taken at the
first screening visit).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

• History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies
• Contraindications for ESA therapy
• Active gastrointestinal bleeding during the screening period
• Evidence of decompensated cirrhosis
• Serum albumin < 3.0 g/dL
• Immunocompromized patients (immunosuppressive treatment, chemotherapy)
• Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency virus (HIV) infection
• Systemic lupus erythematosus
• Symptomatic congestive heart failure (New York Heart Association (NYHA) class III and IV)
• Unstable angina pectoris, or myocardial infarction within 6 months prior to Visit 1
• Percutaneous coronary intervention, or coronary artery bypass grafting during the last 6 months prior to Visit 1
• History of malignancy of any organ system
• History of thrombosis (excluding vascular access thrombosis) or pulmonary embolism
• History of use of any non-EU approved ESA

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified