ong-term efficacy and safety of subcutaneous administration of XM01 in chronic renal failure patients and comparison of once-weekly with three-times weekly administration of XM01 - A multinational, multicentre, randomised, open, parallel-group Phase III study

• Conditions: MedDRA version: 8.0Level: LLTClassification code 10054353; Treatment of anaemia in chronic renal failure patients

• Registration Number: EUCTR2005-000144-87-HU
• Lead Sponsor: BioGeneriX AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

There are only two formal inclusion criteria to be fulfilled at the enrolment visit (Visit 1):
1. Patients who have completed according to protocol the Correction phase study - subcutaneous” or the Maintenance phase study - subcutaneous” can enter this trial.
2. Patients must have signed and dated written informed consent.
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

There are no formal exclusion criteria at Visit 1. However, patients presenting at visit 7 with any of the following will not be randomised:
1. Serum ferritin =100 µg/L or TSAT =20%.
2. Patients with active bleeding.
3. Red blood cell transfusion within the last four weeks.
4. Uncontrolled severe hypertension defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg
5. Tertiary or poorly controlled secondary hyperparathyroidism defined as intact parathyroid hormone (PTH) = 10 times the ULN.
6. Current malignant disease.
7. Current systemic infection or inflammatory disease.
8. Known positive test for human immunodeficiency virus (HIV) antibodies.
9. Concomitant therapy with immunosuppressive drugs, steroids (oral or intravenous) or androgens.
10. Patients with resistance to Epoetin (more than 300 IU/kg body weight/week).
11. Planned travel activities outside the participating countries during the final 12 weeks of the study (week 25-36).
Under no circumstances may patients be enrolled into this study more than once.

Study & Design

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