Efficacy and Safety of Epoetin-Omega i.v. for Treatment of Anemia in Hemodialyzed Patients Hyporesponsive to a Previous Epoetin Beta i.v. Treatment: a Randomized, Parallel Group Trial. - Epomax Hyporesponsive patients study

• Conditions: Anaemia in End Stage Renal Disease (ESRD) Hemodialyzed Patients Hyporesponsive to a Previous Epoetin Beta i.v. Treatment; MedDRA version: 7.0Level: LLTClassification code 10009120

• Registration Number: EUCTR2004-000673-57-AT
• Lead Sponsor: Baxter Healthcare S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-19
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Potential candidates for enrolment will be selected based on a detailed medical history Chart Review. In addition, the potential patients, who have provided written consent, will then undergo a screening visit evaluation in order to confirm their eligibility for inclusion in the study.
In order for a patient to be considered as a potential candidate for enrolment, the following conditions must be verified by objective evidence during the Chart Review

Inclusion Criteria:
1. Patients have been adequately selected by the Chart Review.
2. Patients have provided written and signed informed consent.
3. Hb at the screening visit <11.0 g/dl.
4. Total Epoetin Beta dose delivered in the week between screening and day 1 visit is =200 IU/kg.
5. Delivered Kt/V >1.20 at the screening visit (renal clearance to be added to K in case of RRF (urine volume >100ml and renal urea clearance >0.5ml/min). In the case that the Kt/V determination is not possible, a URR of >65% at the screening visit will be accepted.
6. Patients with an adequate iron status defined as TSAT =20% and ferritin =100µgl 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

1. Patients with a history of a hypertensive crisis within 8 weeks prior to the screening visit.
2. Patients with aluminium overload, defined as serum Al >60 µg/l (or 2.22 µmol/l) at the screening visit.
3. Patients with vitamin B12 deficiency (<200ng/l) or folic acid deficiency (<3.0µg/l) at the screening visit.
4. Patients suffering from cancer that cannot be considered as in remission”.
5. Patients whose life expectancy in the judgment of their physician is 6 months or less.
6. Patients with hemolytic anemia or anemia due to diseases other than ESRD (e.g., hemoglobinopathies, myelodisplasia etc.).7. Patients who have experienced a clinically relevant blood loss or hemolysis within 4 weeks prior to the screening visit.
8. Patients with known epilepsy.
9. Patients with hyperparathyroidism who have:
• Verified osteitis fibrosa and/or indication for parathyroidectomy
• iPTH >500 pg/ml at the screening visit and have not been treated for hyperparathyroidism
• Undergone parathyroidectomy within 6 weeks prior to the screening visit
10. Pregnant or lactating patients.
NB: Female patients of childbearing potential must have a negative serum (or urine if appropriate) pregnancy test at the time of screening and will be required to use a medically acceptable means of contraception during their participation in the study. Women of childbearing potential are defined as women less than 55 years old who have not had a partial or full hysterectomy.
11. Patients with an acute infection / inflammation or an exacerbation of a chronic disease.
12. Patients with HIV.
13. Patients that received erythropoiesis stimulators (other than Epoetin Beta), such as androgens, cytotoxic agents, radiation treatment, high-dose immunosuppressants, interferon or ribavirin within 12 weeks prior to screening. Low-dose immunosuppressants, interferon, ribavirin and similar therapeutic agents that are used on chronic basis for the control of a chronic disease are acceptable.
14. Patients participating in another interventional study.
15. Patients who have received an investigational drug within 30 days prior to the screening visit.
16. Patients with known hypersensitivity to erythropietin or mammalian cell line products or human serum albumin.
17. Patients with a history of acquired pure red cell aplasia (PRCA) of any cause.
18. Patients with serum albumin < 30 g/l at the screening visit.
19. Patients with a history of anti-erythropoietin antibodies.
20. Patients scheduled for living donor renal transplant or other elective surgery within the next 6 months.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: This is an exploratory trial aimed at evaluating the hypothesis that dialyzed anemic patients hyporesponsive to intravenous Epoetin Beta treatment would benefit from switching” the treatment to intravenous Epoetin Omega.;Secondary Objective: ;Primary end point(s): Primary Efficacy Variables:<br>1. Average weekly dose (IU/kg) delivered in weeks 13-16.<br>2. Average Hb (g/dl) in weeks 13-16.<br>3. Average Erythropoietin Resistance Index (ERI) in weeks 13-16.<br>