An Evaluation of the Efficacy of Epo-Omega in The Treatment of Anaemia in Chronic Kidney Disease (CKD) Patients When Administered by Once Weekly Subcutaneous Injection: A Dose Dependency Evaluation. - Epomax (1 x / week s.c.) A dose dependency evaluatio

Phase 1

• Conditions: Anaemia in pre-dialysis Chronic Kidney Disease (CKD) Patients; MedDRA version: 7.0Level: LLTClassification code 10009120

• Registration Number: EUCTR2004-000676-13-SK
• Lead Sponsor: Baxter Healthcare S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08-23
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1.Patients who have provided written informed consent.
2.Patients with stable Hb <11.0g/dL (stable = at least two Hb measurements <11.0 g/dL, a minimum of 7 days apart, in a 42 day period prior to formal screening for the study AND then 3 Hb values taken at screening, in between the Screening Visit and Visit 0 (Day 1) and at Visit 0 (Day 1).
3.A glomerular filtration rate (GFR) of 15-59 ml/min/1.73m2 (stage 3-4, mild to moderate renal impairment) as determined using the Cockcroft-Gault formula.
4.Patients of 18 years of age and above.
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

1.Patients with uncontrolled hypertension (diastolic BP>100mm Hg determined on two separate occasions).
2.Patients with Vit B12 deficiency (<200 ng/L) or folic acid deficiency (<3.0µg/L).
3.Patients with a diagnosis of cancer (except skin cancer) currently under active treatment.
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 with bone involvement 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 the Screening Visit.
11.Patients with acute infection(s).
12.Patients with inflammatory status (CRP >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.

Study & Design

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