A single arm, open label study to assess the efficacy, safety, and tolerability of monthly administration of RO0503821 for the treatment of chronic renal anaemia in patients not on dialysis and not currently treated with ESA.

Phase 1

• Conditions: Chronic renal anaemia; MedDRA version: 9.1Level: LLTClassification code 10058123Term: Renal anaemia

• Registration Number: EUCTR2006-006707-36-FI
• Lead Sponsor: Roche Oy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-29
• Last Update Posted: 7 May 2018

Recruitment & Eligibility

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

Inclusion Criteria

- Written informed consent
- Age 18 years or older
- Patients with chronic kidney disease stage 3 (GFR 30-59 ML/min) or stage 4 (GFR 15-29 ML/min) not requiring dialysis. The GFR can be estimated either by using the Cockroft-Gault formula or the MDRD formula
- Chronic renal anaemia
- Haemoglobin concentration between 9 and 11 g/dl at the initial screening visit
- No prior ESA therapy for 12 weeks prior to and throughout the screening period
- Adequate iron status (serum ferritin = 100ng/mL or TSAT=20%) during screening

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

- Change in haemoglobin concentration = 2g/dL during the 4 weeks screening period
- Transfusion of red blood cells during the 8 weeks prior to the screening visit or during the screening period
- Poorly controlled hypertension
- Relevant 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
- Haemoglobinopathies (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
- CRP > 30mg/L
- Congestive heart failure (NYHA Class IV)
- High likelihood of early withdrawal or interuption of the study (e.g. Myocardial infarction or stroke within 12 weeks of screening, severe or unstable coronary artery disease, severe liver disease)
- Failing renal allograft in place (renal graft rejection)
- Immunosuppressive therapy (other than corticosteroids for a chronic condition) in 12 weeks before screening
- Uncontrolled or symptomatic secondary hyperparathyroidism
- Pregnancy or lactation period
- Women of childbearing potential without effective contraception
- Participation in a clinical trial or receipt of investigational compound or treatment in the 3 months prior to the initial screening visit
- Planned elective surgery during the study period except for
- cataract surgery
- vascular access surgery
- Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- Previous treatment with RO0503821

Study & Design

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