A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00737711
First received: August 18, 2008
Last updated: July 7, 2014
Last verified: July 2014

August 18, 2008
July 7, 2014
July 2008
October 2009   (final data collection date for primary outcome measure)
Mean change in Hb concentration from baseline to last visit [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00737711 on ClinicalTrials.gov Archive Site
  • Time to achievement of response (Hb target range 10.0g/dL - 12g/dL); percentage of patients with average Hb concentration between 10.0g/dL and 12.0g/dL during that last 4 weeks of treatment. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Mean time spent in the Hb range 10.0g/dL - 12.0g/dL during the last 4 weeks of treatment. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Incidence of AEs, SAEs and deaths; vital signs, laboratory parameters, ECG. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Two Weekly Administration of Intravenous MIRCERA for the Treatment of Chronic Renal Anaemia in Dialysis Patients Not Currently Treated With ESA.

This single arm study will evaluate the hemoglobin (Hb) increasing effect, safet y and tolerability of two-weekly intravenous administration of Mircera in dialys is patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks wi th follow up 2 weeks after the last treatment visit. The anticipated time on stu dy treatment is 3-12 months, and the target sample size is 100-500 individuals.

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]
iv 0.6 micrograms/kg every 2 weeks
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
189
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • male or female patients, >=18 years of age;
  • chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
  • no prior erythropoietin stimulating agent (ESA) therapy.

Exclusion Criteria:

  • blood transfusion within the previous 4 weeks;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • active malignant disease;
  • congestive heart failure (NYHA Class IV).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00737711
ML21822
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

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