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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: June 15, 2017
Last verified: May 2017
  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: Intervention Model: Single Group Assignment
Masking: None (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) ]
    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) ]
    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) ]
    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 ]
    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 ]
    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 ]

Enrollment: 191
Actual Study Start Date: April 30, 2009
Study Completion Date: November 30, 2010
Primary Completion Date: November 30, 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)
Sexes Eligible for Study:   All
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
Inje University Busan Paik Hospital; Nephrology
Busan, Korea, Republic of, 633-165
Kyungpook National Uni Hospital; Internal Medicine
Daegu, Korea, Republic of, 700-721
Chungnam National Uni Hospital; Nephrology
Daejeon, Korea, Republic of, 301-721
Chonnam National University Hospital
Gwangju, Korea, Republic of, 61469
NHIC Ilsan Hospital
Kyonggi-do, Korea, Republic of, 411-719
Seoul National Uni Hospital; Internal Medicine
Seoul, Korea, Republic of, 03080
Seoul St Mary's Hospital
Seoul, Korea, Republic of, 06591
Severance Hospital; Division of Nephrology
Seoul, Korea, Republic of, 120-752
East-West Neo Medical Center; Division Of Nephology
Seoul, Korea, Republic of, 134-837
Samsung Medical Centre; Department of Hematology & Oncology
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: June 15, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on September 21, 2017