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A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00737464
First received: August 18, 2008
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 weeks with follow up 2 weeks after the last treatment visit. 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: 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 Intravenous or Subcutaneous 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:
  • Proportion of patients maintaining Hb levels within the target range during the last 4 weeks of the treatment period. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in mean Hb concentration between reference and the last 4 weeks of the treatment period; mean time spent in Hb range 10.0g/dL - 12.0g/dL. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Incidence of adverse events, serious adverse events and deaths; vital signs, laboratory parameters, ECG. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: August 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
iv (120, 200 or 360 micrograms) every 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female patients, >=18 years of age;
  • chronic renal anemia;
  • Hb concentration 10.5g/dL - 12.5g/dL;
  • continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.

Exclusion Criteria:

  • blood transfusion within the previous 2 months;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • active malignant disease;
  • congestive heart failure (NYHA Class IV).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737464

Locations
India
Bangalore, India, 560024
Bangalore, India, 560017
Chennai, India, 600 037
Chennai, India, 600037
Chennai, India, 6000089
Guwahati, India, 781005
Hyderabad, India, 500068
Hyderabad, India, 500082
Kanpur, India, 208005
Kolkata, India, 700029
Meerut, India, 250001
Mohali, India, 160 063
Mumbai, India, 400080
Mumbai, India, 400092
New Delhi, India, 110070
New Delhi, India, 110076
Pune, India, 411001
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00737464     History of Changes
Other Study ID Numbers: ML21810
Study First Received: August 18, 2008
Last Updated: April 18, 2012
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013