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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: May 7, 2013
Last verified: May 2013
History of Changes
  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
 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Procedure: Dialysis
 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 and Intravenous MIRCERA® for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

Resource links provided by NLM:

MedlinePlus related topics: Anemia Dialysis
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • long-term maintenance of hemoglobin levels in target range [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in haemoglobin levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • mean time spent in haemoglobin range 10.0-12.0 g/dl [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety and tolerability: Adverse events, laboratory parameters, dose adjustments, red blood cell transfusions [ Time Frame: throughout study, laboratory assessments every 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: November 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
once monthly, subcutaneously or intravenously, for 32 weeks
Procedure: Dialysis
regular haemodialysis or peritoneal dialysis

  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 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
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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01156363     History of Changes
Other Study ID Numbers: ML22299
Study First Received: July 1, 2010
Last Updated: May 7, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013