A Study of Mircera for the Maintenance Treatment of Patients With Chronic Renal Anemia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00550680
First received: October 29, 2007
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

This single arm study will assess the efficacy and safety of intravenous Mircera when administered for the maintenance of hemoglobin levels in patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200 or 360 micrograms iv) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start. 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 Mircera 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:
  • Percentage of patients maintaining average Hb concentration within target range of 10.5-12.5g/dL during evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Hb concentration and percentage of patients maintaining Hb concentration in target range throughout evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean time in Hb target range; percentage of patients needing dose adjustments; incidence of RBC transfusions [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 189
Study Start Date: February 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (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 monthly, 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;
  • stable epoetin alfa or darbepoetin alfa therapy for past 2 months;
  • hemodialysis therapy for >=3 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring hospitalization or interruption of erythropoetin treatment in previous 6 months;
  • acute or chronic bleeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550680

Locations
Greece
Agios Nikolaos Crete, Greece, 72100
Arta, Greece, 47100
Athens, Greece, 11528
Athens, Greece, 11526
Athens, Greece, 11527
Athens, Greece, 11362
Athens, Greece, 18454
Athens, Greece, 18536
Athens, Greece, 12462
Cephallonia, Greece, 28100
Corinthos, Greece, 20100
Daphni-athens, Greece, 17237
Egaleo, Greece, 12244
Ioannina, Greece, 455 00
Kalamata, Greece, 24100
Kyparissia, Greece, 24500
Lamia, Greece, 35100
Larissa, Greece, 41221
Larissa, Greece, 41 110
Leivadia, Greece, 32100
Mitilini, Greece, 81100
Patra, Greece, 26225
Preveza, Greece, 48100
Rhodes, Greece, 85100
Thessaloniki, Greece, 54629
Thessaloniki, Greece, 546 42
Thessaloniki, Greece, 57001
Thessaloniki, Greece, 57010
Veria, Greece, 59100
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: NCT00550680     History of Changes
Other Study ID Numbers: ML20952
Study First Received: October 29, 2007
Last Updated: October 17, 2013
Health Authority: Greece: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014