Anaemia in pre-dialysis Chronic Kidney Disease (CKD) Patients MedDRA version: 7.0 Level: LLT Classification code 10009120
Conditions
Interventions
Product Name: EPOMAX 5000 IU, solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: epoetin omega
Current Sponsor code: rHu-EPO
Concentration unit: IU international u
Sponsors
Baxter Healthcare S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have provided written informed consent. 2. Patients with stable Hb =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with uncontrolled hypertension (diastolic BP>100mm Hg determined on two separate occasions). 2. Patients with Vit B12 deficiency (30mg/L). 13. Patients with HIV. 14. Patients with biochemical evidence of significant liver disease (with transaminases >2X upper limit). 15. Patients who have received cytotoxic agents, immunosuppressives or radiation therapy within 30 days prior to the Screening Visit. 16. Patients participating in another interventional study. 17. Patients who have received investigational drug within 30 days prior to the Screening Visit. 18. Patients with known hypersensitivity to Epoetin, or mammalian cell line products or human serum albumin. 19. Patients with a history of pure red cell aplasia (any cause). 20. Patients with a history of anti-EPO antibodies. 21. Patients with a serum albumin < 30 g/L. 22. Patients with a life expectancy < 6 months. Patients who have had a renal transplant are allowed to participate in the study, as are those who are on the transplant waiting list. Those who are scheduled to have a living related donor operation within the next 3 months must be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the dose dependency of the anti-anaemic effects of Epoetin-Omega administered by once weekly subcutaneous (s.c.) injection in anaemic pre-dialysis CKD patients.;Secondary Objective: The trial will particularly evaluate whether the effect of Epoetin Omega on blood pressure shows any dose-dependent trends.;Primary end point(s): 1. Response rate. The Response Rate is the proportion of ?responders?, where response to the assigned dose is defined as Packed Red Cell (PRC) transfusion-independent attainment of Hb levels during the trial that meet one of the following criteria: a) two consecutive weekly Hb values >1.0 g/dL higher than the baseline Hb (HbB); b) Hb level is >13.0 g/dL at least once, c) reduction in Epoetin dose due to a too rapid increase in Hb (i.e. > 2.5 g/dL/2 weeks). The baseline Hb level is defined as the average value of three Hb concentrations determined at the Screening Visit, in between the Screening Visit and Visit 0, and at Visit 0. 2. The weekly change in Hb until the end of the study. This parameter is defined as the weekly consecutive differences in Hb for each patient (Hbi - Hbi-1, where i is the visit number and may range from 1 to 12). For Visit 1, the value Hbi-1 is the baseline Hb value. The duration of the observed period is from enrolment until one of the following events (whichever occurs first). a) The Hb level > 13 g/dL. b) Patient requires an Epoetin dose increase. c) Patient requires an Epoetin dose decrease. d) Patient receives a PRC transfusion. e) Patient drops out of the study and Hb values are no longer available. f) The planned end of the study (completed 12 weeks). | — |
Countries
Slovakia
Outcome results
None listed