A Study of Subcutaneous Mircera for the Maintenance Treatment of Pre-Dialysis Patients With Chronic Renal Anemia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00517881
First received: August 16, 2007
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

This single arm study will assess the efficacy and safety of subcutaneous Mircera for maintenance of hemoglobin levels in pre-dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of Mircera with the starting dose (120, 200 or 360 micrograms) derived from the dose of darbepoetin alfa or epoetin alfa 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 Hemoglobin Levels, Safety and Tolerability of Once Monthly Administration of Subcutaneous Mircera in Pre-dialysis Patients With Chronic Renal Anemia

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients maintaining average Hb concentration in target range during evaluation period [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Hb concentration and percentage of patients maintaining Hb concentration in target range during evaluation period [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean time spent in target range; percentage of patients needing dose adjustments; incidence of RBC transfusions [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: July 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (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 sc 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;
  • continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months;
  • acute or chronic bleeding.
  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: NCT00517881

Locations
Sweden
Bollnas, Sweden, 821 81
Danderyd, Sweden, 18288
Eksjo, Sweden, 57581
Eskilstuna, Sweden, 63188
Gaevle, Sweden, 80187
Goeteborg, Sweden, 41345
Gothenburg, Sweden, S-402 76
Huddinge, Sweden, 14186
Jonkoping, Sweden, 55185
Karlshamn, Sweden, S-374 80
Karlstad, Sweden, 65185
Kristianstad, Sweden, 29185
Linkoeping, Sweden, S-581 85
Lund, Sweden, 22185
Skellefteå, Sweden, S-931 86
Stockholm, Sweden, 17176
Trollhaettan, Sweden, 46185
Umea, Sweden, 90185
Uppsala, Sweden, 75185
Värnamo, Sweden, 33185
Västervik, Sweden, 59381
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: NCT00517881     History of Changes
Other Study ID Numbers: ML20944
Study First Received: August 16, 2007
Last Updated: November 4, 2013
Health Authority: Sweden: Lakemedelsverket (MPA)

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on July 09, 2014