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A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576303
First received: December 18, 2007
Last updated: October 14, 2011
Last verified: October 2011
History of Changes
  Purpose

This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. 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 3

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: An Open Label Study to Assess the Maintenance of Haemoglobin Levels, Safety and Tolerability of Monthly Administration of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anaemia Who Are Currently Receiving Epoetin Alfa or Beta.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients maintaining average Hb concentration within target range of 10.5-12.5g/L during evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Hb concentration over evaluation period [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
  • Percentage of patients maintaining Hb concentration in target range throughout evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean time spent in Hb target range; mean number of months/subject requiring dose adjustments; incidence of RBC transfusions. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: February 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms iv monthly (starting dose)

  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 anemia;
  • hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before and throughout screening period;
  • continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;
  • significant acute or chronic bleeding such as overt gastrointestinal bleeding;
  • hemolysis;
  • folic acid and vitamin B12 deficiency.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576303

Locations
Russian Federation
Ekaterinburg, Russian Federation, 620102
Kemerovo, Russian Federation, 650066
Krasnodar, Russian Federation, 350086
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 129317
Moscow, Russian Federation, 129110
Moscow, Russian Federation, 117049
Moscow, Russian Federation, 123182
Moscow, Russian Federation, 127006
Novosibirsk, Russian Federation, 630087
Omsk, Russian Federation, 644111
St Petersburg, Russian Federation, 191015
St Petersburg, Russian Federation, 197089
St Petersburg, Russian Federation, 197110
St Petersburg, Russian Federation, 196247
St Petersburg, Russian Federation, 195067
St-petersburg, Russian Federation, 198510
Volzhsky, Russian Federation, 404130
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: NCT00576303     History of Changes
Other Study ID Numbers: ML20977
Study First Received: December 18, 2007
Last Updated: October 14, 2011
Health Authority: Russia: Federal Agency of Drug Quality Control

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
 Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 23, 2013