E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Anaemia in End Stage Renal Disease (ESRD) hemodialyzed Patients
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009120 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
The trial will also evaluate the dose dependency of possible untoward effects. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Patients who have provided written informed consent. 2. Patients with stable Hb <10.5g/dL (stable = at least two Hb measurements <10.5g/dL, a minimum of 7 days apart, in a 42 day period prior to formal screening for the study. 3. Haemodialysis 3X/W for a minimum of 3 months and with delivered Kt/V ≥1.20/session (renal clearance to be added to K in case of residual renal function (RRF) [urine volume >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. |
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E.4 | Principal 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 (<200 ng/L) or folic acid deficiency (<3.0µg/L). 3. Patients receiving treatment for cancer. 4. Patients with haemolytic anaemia or anaemia due to other diseases. 5. Patients with clinically persistent blood loss (e.g. gastrointestinal). 6. Patients with known epilepsy. 7. Patients with severe hyperparathyroidism and/or indication for parathyroidectomy. 8. Pregnant or lactating patients. N.B. Female patients of childbearing potential must have a negative serum pregnancy test at the time of screening and will be required to use a medically acceptable means of contraception during their participation in this study. 9. Patients who have received Interferon or Ribavirin within 30 days prior to the screening visit. 10. Patients who have received Epoetin (Alpha, Beta) or darbepoetin alfa treatment, androgens or transfusions within the last 90 days prior to screening. 11. Patients with acute infection(s). 12. Patients with inflammatory status (CRP >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. |
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Visit 12 (Week 12) is the end of study visit . |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |