A single arm, open label study to assess the efficacy, safety and tolerability of once-monthly administration of subcutaneous RO0503821 for the maintenance of haemoglobine levels in patients with chronic renal anaemia not on dialysis (CKD stage 1-4) - ARIANE

• Conditions: chronic renal anemia; MedDRA version: 9.1Level: PTClassification code 10058116Term: Nephrogenic anaemia

• Registration Number: EUCTR2007-001720-13-NL
• Lead Sponsor: Roche Nederland B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

•Written informed consent
•Age 18 years or older
• Chronic renal anaemia
•Haemoglobin concentration between 10.5 and 12.5 g/dl (6.5 and 7.8
mmol/L) at the initial screening visit.
•Adequate iron status (serum ferreting = 100ng/mL or TSAT=20%) during
screening
•Continuous subcutaneous maintenance darbepoetin alfa or epoetin beta
therapy with the same dosing interval for 8 weeks prior to and throughout
the screening period

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

•Transfusion of red blood cells during the 8 weeks prior to or during the
screening period
•Poorly controlled hypertension, i.e. sitting bloodpressure exceeds 170/100
despite medication requiring hospitalisation or interruption of epoetin beta
or darbepoetine alfa treatment in the previous 6 months.
•Significant or acute or chronic bleeding, i.e. requiring therapy within 8
weeks prior to screening e.g. overt gastrointestinal bleeding
•Active malignant disease (except non-melanoma skin cancer)
•Haemolysis
•Haemoglobinpathies (e.g. homozygous sickle-cell disease, thalassemia of
all types)
•Folic acid deficiency
•Vitamin B12 deficiency
•Platelet count > 500 x 109/L or <100 x 109/L at screening visit
•Pure red call aplasia
•Epileptic seizure in 6 months before screening
•Congestive heart failure (NYHA Class IV)
•Myocardial infarction or stroke within 12 weeks of screening, severe or
unstable coronary artery disease, severe liver disease
•Uncontrolled or symptomatic secondary hyperparathyroidism
•Pregnancy or lactation period etc.
•Women of childbearing potential without effective contraception
•Participation in a clinical trial or receipt of investigational compound in the
3 months prior to the initial screening visit
•Planned elective surgery during the study period except for cataract
surgery and vascular access surgery
•Known hypersensitivity to recombinant human erythropoietin,
polyethylene glycol or to any constituent of the study medication

Study & Design

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