An open-label, randomized, multicenter, parallel group study to demonstrate correction of anemia using once monthly subcutaneous injections of RO0503821 in patients with chronic kidney disease who are not on dialysis - N/A

• Conditions: Chronic renal anemia; MedDRA version: 8.1Level: LLTClassification code 10058124Term: Nephrogenic anemia

• Registration Number: EUCTR2006-001434-41-SE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

1. Written informed consent
2. Adult patients (=18 years old) with CKD stage 3 (CrCl/Glomerular filtration rate (GFR) 30-59 mL/min/ 1.73m2) or stage 4 (CrC1/GFR 15-29 mL/min/1.73m2) not requiring dialysis. CrC1/GFR will be estimated at the first screening visit with the Cockcroft-Gault equation or the abbreviated MDRD equation, derived from the full MDRD equation.
3. Anemia defined as baseline Hb concentration between 8.0 and 11.0 g/dL determined from the mean of two screening values with at least one day between measurements
4. Adequate iron status defined as serum ferritin =100 ng/mL or TSAT =20% (or percentage of hypochromic RBCs <10%) determined from the mean of two screening values with at least one day between measurements

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

1. Need for dialysis therapy expected in the next 6 months or rapid progression of CKD (eg, a CrC1/GFR decrease of more than 20% within 12 weeks)
2. Previous therapy with any ESA within 12 weeks prior to the first screening visit or during the screening period. If ESA treatment has been interrupted for at least 12 weeks, the patient may be enrolled in the study. Ongoing ESA treatment should not be discontinued to allow participation in the trial
3. Renal allograft in place
4. Immunosuppressive therapy (other than corticosteroids for a chronic condition, cyclosporine and monoclonal/polyclonal antibodies) in the 12 weeks before the first screening visit or during the screening period
5. Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
6. RBC transfusions within 8 weeks before screening or during the screening period
7. Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types)
8. Hemolysis
9. Active malignant disease (except non-melanoma skin cancer). Patients with malignant disease who have been disease-free for at least the 5 previous years are eligible
10. Chronic, uncontrolled or symptomatic inflammatory disease (eg, rheumatoid arthritis, systemic lupus erythematosus)
11. Acute infection
12. CRP >15 mg/L (measured at screening)
13. Vitamin B12 deficiency
14. Folic acid deficiency
15. Uncontrolled or symptomatic secondary hyperparathyroidism
16. Poorly controlled hypertension (sitting SBP =160 mmHg or DBP =100 mmHg – average of two values with at least one day between measurements)
17. Epileptic seizure in the 6 months before screening
18. Platelets >500 x 10 exp9/L (measured at screening)
19. Pure red cell aplasia (PRCA) or history of PRCA
20. Chronic congestive heart failure Class IV (New York Heart Association classification)
21. High likelihood of early withdrawal or interruption of the study (e.g., myocardial infarction, severe or unstable coronary artery disease, stroke or severe liver disease within the 12 weeks before screening or during the screening period)
22. Planned elective surgery during the study period (patients who undergo vascular access surgery, cataract surgery or laser photocoagulation may continue to participate)
23. Life expectancy less than 12 months
24. Pregnancy or breast-feeding
25. Women of childbearing potential without effective contraception
26. Administration of another investigational drug within 4 weeks before screening or planned during the study period
27. Known hypersensitivity to any constituents of the study or reference drug formulations
28. Previous treatment with RO0503821

Study & Design

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