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A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01066000
First received: February 9, 2010
Last updated: May 23, 2013
Last verified: May 2013
History of Changes

February 9, 2010
May 23, 2013
October 2009
September 2011   (final data collection date for primary outcome measure)
Long-term maintenance of haemoglobin levels [ Time Frame: Throughout study, weeks 1 and 2 and every 2 weeks thereafter ] [ Designated as safety issue: No ]
Long-term maintenance of haemoglobin levels [ Time Frame: Throughout study, weeks 1 and 2 and every 2 weeks thereafter ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01066000 on ClinicalTrials.gov Archive Site
Safety and Tolerability: AEs, laboratory parameters [ Time Frame: Laboratory parameters: throughout study, weeks 1 and 2 and every 2 weeks thereafter ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia
A Single Arm Open Label Interventional Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous Methoxy-polyethylene Glycol-epoetin Beta for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

This open-label single-arm study will evaluate the efficacy, safety and tolerability of methoxy polyethylene glycol epoetin beta on long-term maintenance of haemoglobin levels in patients with chronic renal anaemia. Patients will receive methoxy polyethylene glycol-epoetin beta intravenously once monthly at initial doses of either 120 micrograms or 200 micrograms or 360 micrograms in the titration phase of 16 weeks with a potential dose adjustment in the evaluation phase of 8 weeks. The anticipated time on study treatment is 24 weeks. The target sample size is 50-100 patients.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly
Experimental: 1
Intervention: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults >/=18 years of age
  • Chronic renal anaemia
  • Haemoglobin concentration between 10 and 12 g/dL at screening
  • Adequate iron status
  • Continuous intravenous maintenance short-acting therapy with same dosing interval for 8 weeks prior to screening
  • Regular long-term haemodialysis therapy for at least 12 weeks prior to screening

Exclusion Criteria:

  • Change in haemoglobin concentration >/=2 g/dL during screening
  • Transfusion of red blood cells less than 8 weeks prior to screening
  • Poorly controlled hypertension
  • Relevant acute or chronic bleeding requiring treatment less than 8 weeks prior to screening
  • Active malignant disease
  • Haemolysis
  • Haemoglobinopathies
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01066000
ML21736
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP