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A Study of Subcutaneous Mircera for the Maintenance Treatment of Patients With Chronic Renal Anemia Not on Dialysis.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00642304
First received: March 19, 2008
Last updated: September 21, 2011
Last verified: September 2011
History of Changes
  Purpose

This single arm study will assess the efficacy and safety of subcutaneous Mircera when administered for the maintenance of hemoglobin levels in patients with chronic renal anemia, not on dialysis. Patients currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of Mircera, with the starting dose (120, 200 or 360 micrograms s.c.) derived from the dose of darbepoetin alfa or epoetin 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: A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneously Mircera for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis

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:
  • Percentage of patients maintaining average Hb concentration within target range of 10.5-12.5g/dL 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 throughout evaluation period. [ Time Frame: Week 17-24 ] [ Designated as safety issue: No ]
  • Mean time 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: 22
Study Start Date: March 2008
Study Completion Date: September 2009
Primary Completion Date: September 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;
  • stable darbepoetin alfa or epoetin beta therapy for past 8 weeks.

Exclusion Criteria:

  • transfusion of red blood cells during previous 8 weeks;
  • poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months;
  • acute or chronic bleeding requiring therapy within previous 8 weeks.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642304

Locations
Netherlands
Almelo, Netherlands, 7600 SZ
Amersfoort, Netherlands, 3800 BM
Amsterdam, Netherlands, 1034 CS
Assen, Netherlands, 9401 RK
Beverwijk, Netherlands, 1942LE
Breda, Netherlands, 4818 CK
Delft, Netherlands, 2625 AD
Doetinchem, Netherlands, 7009 BL
Dordrecht, Netherlands, 3318 AT
Drachten, Netherlands, 9202 NN
Goes, Netherlands, 4462 RA
Gouda, Netherlands, 2803 HH
Heerlen, Netherlands, 6419 PC
Hoogeveen, Netherlands, 7909
Leiden, Netherlands, 2333 ZA
Leiderdorp, Netherlands, 2353 GA
Maastricht, Netherlands, 6202
Nijmegen, Netherlands, 6525 GA
Rotterdam, Netherlands, 3083 AN
Rotterdam, Netherlands, 3015 GD
Rotterdam, Netherlands, 3078 HT
Terneuzen, Netherlands, 4535 PA
Utrecht, Netherlands, 3582 KE
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: NCT00642304     History of Changes
Other Study ID Numbers: ML20937
Study First Received: March 19, 2008
Last Updated: September 21, 2011
Health Authority: Netherlands:Medicines Evaluation Board

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013