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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 1, 2010
Last updated: October 30, 2015
Last verified: October 2015
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
Procedure: Dialysis
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Phase 4

Study Type: Interventional
Study Design: 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01156363

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

Responsible Party: Hoffmann-La Roche 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

Additional relevant MeSH terms:
Hematologic Diseases processed this record on May 25, 2017