An open-label, multi-center study to document the efficacy, safety and tolerability of long-term administration of RO0503821 in patients with chronic renal anemia

Phase 1

• Conditions: Patient with chronic renal anaemia

• Registration Number: EUCTR2004-002032-26-ES
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-11-12
• Study Completion: 2010-01-22
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1.1.Written informed consent
2.Adult patients (equal or more than 18 years old) with chronic renal anemia
3.Continuous maintenance erythropoietic therapy with RO0503821 or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528, BA16285, BA16286, BA16736, BA16738, BA16739, BA16740, BA17283 and BA17284
4.Hemoglobin concentration between 10.5 and 13.0 g/dL
5.Adequate iron status defined as serum ferritin equal or more than 100 ng/mL or TSAT equal or more than 20% (or percentage of hypochromic RBCs < 10%)

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

6.Poorly controlled hypertension necessitating interruption of erythropoietin treatment in the 6 months before screening
7.Epileptic seizure in the 6 months before screening
8.Platelets > 500 x 10 9/L
9.Pure red cell aplasia
10.Chronic congestive heart failure (New York Heart Association Class IV)
11.High likelihood of early withdrawal or interruption of the study (e.g., myocardial infarction, severe or unstable coronary artery disease, stroke, severe liver disease within the 12 weeks before screening)
12.Active malignant disease (except non-melanoma skin cancer)
13.Life expectancy less than 12 months
14.Pregnancy or breast-feeding
15.Women of childbearing potential without effective contraception
16.Administration of another investigational drug planned during the study period
17.Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study or reference drug formulations

Study & Design

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