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: November 4, 2015
Last verified: November 2015
  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 receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent 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: 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:
  • Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP) [ Time Frame: EEP (Weeks 17 to 24) ] [ Designated as safety issue: No ]
    The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.


Secondary Outcome Measures:
  • Change in Hemoglobin Concentration Between SVP and the EEP [ Time Frame: SVP (Baseline), and EEP (Weeks 17 to 24) ] [ Designated as safety issue: No ]
    Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24.

  • Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP [ Time Frame: EEP (Weeks 17 to 24) ] [ Designated as safety issue: No ]
    EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson.

  • Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP [ Time Frame: Weeks 1 to 24 ] [ Designated as safety issue: No ]
    DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.

  • Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP [ Time Frame: Weeks 1 to 24 ] [ Designated as safety issue: No ]
    DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.

  • Average Dose of Mircera Per Month [ Time Frame: Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24 ] [ 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   (Adult, Senior)
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, 61469
Kyonggi-do, Korea, Republic of, 411-719
Seoul, Korea, Republic of, 06591
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 134-837
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00922116     History of Changes
Other Study ID Numbers: ML22285 
Study First Received: June 16, 2009
Results First Received: November 4, 2015
Last Updated: November 4, 2015
Health Authority: Korea:FDA

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on July 21, 2016