A Study of Intravenous Mircera in Patients With Chronic Renal Anemia Who Are on Dialysis.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00660023
First received: April 16, 2008
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

This single arm study will assess the efficacy and safety of monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia in routine clinical practice in Hungary. Patients currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the ESA dose they had been receiving. The anticipated time on study treatment is 3-12 months, and the target 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 Dialysis Patients With Chronic Renal Anaemia

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients maintaining average Hb concentration within target range during the Efficacy Evaluation Period (EEP) [ Time Frame: Week 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Hb concentration [ Time Frame: Between reference and EEP ] [ Designated as safety issue: No ]
  • Percentage of patients maintaining Hb within target range. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
  • Percentage of patients requiring dose adjustments; incidence of RBC transfusions. [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: June 2008
Study Completion Date: June 2011
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
i.v. every month (starting dose based on previous ESA therapy).

  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 intravenous maintenance epoetin or darbepoetin therapy during previous month;
  • regular long term dialysis therapy, with the same mode of dialysis for the previous 3 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension;
  • 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: NCT00660023

Locations
Hungary
Baja, Hungary, 6500
Budapest, Hungary, 1062
Debrecen, Hungary, 4032
Esztergom, Hungary, 2500
Keszthely, Hungary, 8360
Miskolc, Hungary, 3526
Salgótarján, Hungary, 3100
Szolnok, Hungary, 5000
VAC, Hungary, 2600
Zalaegerszeg, Hungary, 8900
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00660023     History of Changes
Other Study ID Numbers: ML20752, 2006-005621-28
Study First Received: April 16, 2008
Last Updated: January 17, 2012
Health Authority: Hungary: National Institute of Pharmacy, Central ethics Committee

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on August 26, 2014