A randomized, controlled, open-label, multi-center, parallel group study to demonstrate efficacy and safety of RO0503821 when administered with pre-filled syringes for the maintenance treatment of anemia in patients with chronic kidney disease who are on dialysis.

Phase 1

• Conditions: Patients with Chronic Kidney Disease who are on dialysis

• Registration Number: EUCTR2004-000081-13-GB
• 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: 2005-02-14
• Study Completion: 2005-10-20
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 264

Inclusion Criteria

1. Written informed consent

2. Adult patients (= 18 years old) with chronic renal anemia

3. Regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 12 weeks before screening and during the screening/baseline period

4. Kt/V =1.2 or URR =65% for patients on thrice-weekly hemodialysis or weekly Kt/V =1.8 for peritoneal dialysis patients. Hemodialysis patients with fewer or more dialysis sessions per week should have a weekly Kt/V =3.6

5. Baseline haemoglobin concentration between 10.5 and 13 g/dL (mean of the weekly haemoglobin values determined in weekly -4 to-1)

6. Stable baseline haemoglobin concentrations (defined as an absolute difference less than or equal to 1g/dL between the mean haemoglobin values determined in weeks -4 and -3 and the mean hemoglobin values determined in weeks -2 and -1)

7. Continuous maintenance Epoetin therapy (Epoetin alfa formulated with human albumin or Epoetin beta) with the same dosing interval (i.e., one, two or three times weekly) and route (intravenous or subcutaneous) for at least 8 weeks before screening (a maximum of one missed does is allowed)

8. Continuous maintenance Epoetin therapy (Epoetin alfa formulated with human albumin or Epoetin beta) with the same dosing interval (i.e., one, two or three times weekly) and route (intravenous or subcutaneous) during screening/baseline period (no missed dose is allowed)

9. Stable maintenance Epoetin therapy (Epoetin alfa formulated with human albumin or Epoetin beta) during screening/baseline period (a maximum of one change of the weekly dose is allowed: this change should not exceed 25% compared to the weekly dose administered in the week preceding screening)

10. Adequate iron status defined as serum ferritin = 100 ng/mL or TSAT = 20% (or percentage of hypochromic red cells < 10%);( mean of two values determined in week -4 and -3).

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. Overt gastrointestinal bleeding or any other bleeding episode necessitating transfusion within 8 weeks before screening or during the screening/baseline period

2. RBC transfusions within 8 weeks before screening or during the screening/baseline period

3. Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)

4. Hemolysis

5. Active malignant disease except non-melanoma skin cancer

6. Chronic, uncontrolled or systematic inflammatory disease (e.g. rheumatoid arthritis, systemic lupus erythematosus)

7. Acute infection

8. CRP > 30mg/L

9. Temporary (untunneled) dialysis access catheter

10. Vitamin B12 deficiency

11. Folic acid deficiency

12. Uncontrolled or symptomatic secondary hyperparathyroidism

13. Poorly controlled hypertension necessitating interruption of Epoetin treatment in the 6 months before screening

14. Epileptic seizure in the 6 months prior to screening

15. Platelets > 500x109 /L

16. Pure red cell aplasia

17. Chronic congestive heart failure (New York Heart Association Class IV)

18. High likelihood of early withdrawal or interruption of the study (e.g. myocardial infraction, severe or unstable coronary artery disease, stroke, severe liver disease within the 12 weeks before screening or occurring during the screening period)

19. Planned elective surgery during the study period

20. Life expectation less than 12 months

21. Pregnancy or breast feeding

22. Woman of childbearing potential without effective contraception

23. Previous treatment with RO0503821

24. Administration of another investigational drug within 4 weeks before screening or planned during the study period

25. Know hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituents of the study or reference drug formulations

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that RO0503821 administered in pre-filled syringes maintains hemoglobin concentrations in dialysis patients on prior intravenous or subcutaneous Epoetin maintenance treatment of chronic renal anemia.;Secondary Objective: To assess the safety and tolerability of RO0503821 administered with pre-filled syringes in this patient population.;Primary end point(s): The change in hemoglobin concentration between the baseline and evaluation period.