A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00661505
First received: April 16, 2008
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This single arm study will assess the efficacy, safety and tolerability of once- monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 3 60 micrograms. The anticipated time on study treatment is 3-12 months, and the t arget sample size is 100-500 individuals.


Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Haemodialysis Patients With Chronic Renal Anaemia.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • % patients maintaining mean Hb conc. within target range during the Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 16-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in mean Hb conc. [ Time Frame: Between reference and EEP ] [ Designated as safety issue: No ]
  • % patients maintaining Hb within target range [ Time Frame: Weeks 16-24 ] [ Designated as safety issue: No ]
  • % patients requiring dose adjustments; incidence of RBC transfusions [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
  • AEs, lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 132
Study Start Date: May 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms iv every 4 weeks (starting dose)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >= 18 years of age;
  • chronic renal anemia;
  • continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
  • regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring hospitalization or interruption of epoetin treatment in previous 6 months;
  • significant acute or chronic bleeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661505

Locations
Turkey
Adana, Turkey, 01330
Ankara, Turkey, 06490
Ankara, Turkey, 06500
Ankara, Turkey, 06100
Aydin, Turkey, 09100
Diyarbakir, Turkey, 10000
Edirne, Turkey, 22030
Elazig, Turkey, 23110
Erzurum, Turkey, 25240
Istanbul, Turkey, 34662
Istanbul, Turkey, 34390
Istanbul, Turkey, 34377
Izmir, Turkey
Izmir, Turkey, 35290
Kayseri, Turkey, 38039
Malatya, Turkey, 44300
Mersin, Turkey, 33169
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00661505     History of Changes
Other Study ID Numbers: ML21096
Study First Received: April 16, 2008
Last Updated: July 7, 2014
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014