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A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01156363
First received: July 1, 2010
Last updated: October 30, 2015
Last verified: October 2015
  Purpose
This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta [Mircera] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is <200 patients.

Condition Intervention Phase
Anemia
Procedure: Dialysis
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 and 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 Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range [ Time Frame: Weeks 1 to 32 ] [ Designated as safety issue: No ]
    Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter [g/dL]) throughout the treatment period were reported.


Secondary Outcome Measures:
  • Mean Monthly Hb Values [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8 ] [ Designated as safety issue: No ]
    The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).

  • Change in Hb Concentration Between Reference and Treatment Period [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8 ] [ Designated as safety issue: No ]
    The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).

  • Mean Time Participants Spent Having Hb Concentration Within Target Range [ Time Frame: Weeks 1 to 32 ] [ Designated as safety issue: No ]
    Target Hb concentration was between 10.0 and 12.0 g/dL.

  • Percentage of Participants Requiring Dose Adjustments [ Time Frame: Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8 ] [ Designated as safety issue: No ]
    Dose adjustment included: Dose Increase; No Change; and Dose Decreased. Participants who did not have this data available are reported as Not Done. Results are reported for overall treatment arm.


Enrollment: 86
Study Start Date: October 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Procedure: Dialysis
regular haemodialysis or peritoneal dialysis
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
once monthly, subcutaneously or intravenously, for 32 weeks

  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 anaemia
  • haemoglobin 10.0-12.0g/dl at screening
  • adequate iron status
  • continuous stable ESA (erythropoietic stimulating agent) therapy for >/= 2 months
  • regular haemodialysis or regular peritoneal dialysis for >/= 3 months

Exclusion Criteria:

  • uncontrolled hypertension
  • haemoglobinopathy
  • anaemia due to haemolysis
  • pure red cell aplasia (PRCA)
  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: NCT01156363

Locations
Taiwan
Kaohsiung, Taiwan, 807
New Taiepei City, Taiwan
Taichung, Taiwan, 404
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01156363     History of Changes
Other Study ID Numbers: ML22299 
Study First Received: July 1, 2010
Results First Received: October 30, 2015
Last Updated: October 30, 2015
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on September 23, 2016