A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00922116
First received: June 16, 2009
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will rece ive sc Mircera at a starting dose of 100, 120, 150 or 200 micrograms every 4 wee ks, calculated from the last weekly dose of ESA previously administered. Subsequ ent doses will be adjusted to maintain hemoglobin levels within the target range 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 4

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 Subcutaneous Mircera® for the Maintenance of Haemoglobin Levels in Patients With Chronic Renal Anaemia Who Are Not on Dialysis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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

Secondary Outcome Measures:
  • Adverse events; laboratory parameters [ Time Frame: At planned visits, to week 28 ] [ Designated as safety issue: No ]

Enrollment: 191
Study Start Date: April 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
sc every month (starting dose of 100, 120, 150 or 200 micrograms 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 maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • active malignant disease (except non-melanoma skin cancer).
  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: NCT00922116

Locations
Korea, Republic of
Busan, Korea, Republic of, 633-165
Daegu, Korea, Republic of, 700-721
Daejeon, Korea, Republic of, 301-721
Gwangju, Korea, Republic of, 501-757
Kyonggi-do, Korea, Republic of, 411-719
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 134-837
Seoul, Korea, Republic of, 137-701
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: NCT00922116     History of Changes
Other Study ID Numbers: ML22285
Study First Received: June 16, 2009
Last Updated: October 6, 2014
Health Authority: Korea:FDA

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on October 29, 2014