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 6, 2014
Last verified: October 2014
  Purpose

This open label, single arm study will assess the efficacy for long-term mainten ance of haemoglobin levels and the safety and tolerability of methoxy polyethyle ne glycol-epoetin beta [Mircera] in dialysis patients with chronic renal anaemia Patients on regular long-term haemodialysis or peritoneal dialysis will receiv e monthly subcutaneous or intravenous Mircera for 6 months. Target sample size i s <200 patients.


Condition Intervention Phase
Anemia
Procedure: Dialysis
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
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:


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: 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
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

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: October 6, 2014
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on October 30, 2014