Anaemia in End Stage Renal Disease (ESRD) hemodialyzed Patients MedDRA version: 7.0 Level: LLT Classification code 10009120
Conditions
Interventions
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Product Name: NEORECORMON
Pharmaceutical Form: Powder and solvent for solution
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 100mL] and renal urea clearance >0.5mL/min). In the case that Kt/V determinations are not possible, a urea reduction rate (URR) of > 65% will be accepted. 4. Patients 18-75 years of age (inclusive). 5. Patients with an adequate iron status defined as serum ferritin =100µg/L and transferrin saturation =20% at the screening visit. 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
Exclusion criteria: 1. Patients with uncontrolled hypertension (diastolic BP >100 mm Hg determined during two separate pre-dialysis measurements, preferably the second session of the week). 2. Patients with Vit B12 deficiency (30mg/L). 13. Patients with HIV. 14. Patients with chronic hepatitis C or chronic hepatitis B (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, mammalian cell line products or human serum albumin. 19. Patients with a history of pure red cell aplasia (any cause). 20. Patients with a serum albumin < 30 g/L. 21. 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 effects of Epoetin-Omega administered by thrice weekly intravenous (i.v.) injection on erythropoiesis in anaemic renal patients on haemodialysis.;Secondary Objective: The trial will also evaluate the dose dependency of possible untoward effects.; 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 >1.5 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
Czech Republic
Outcome results
None listed