A Study of Intravenous or Subcutaneous Mircera in Chronic Kidney Disease Patients With Renal Anemia. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00090753

Purpose

This single arm study will assess the long term efficacy, safety and tolerability of intravenous (iv) or subcutaneous (sc) Mircera in chronic kidney disease patients with renal anemia. Eligible patients will be those who are currently receiving stable maintenance therapy with Mircera in Phase II or III clinical studies. They will continue to receive Mircera at the same weekly dose and by the same route of administration (sc or iv) every 2 or every 4 weeks, as in the qualifying studies. The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.

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

MedlinePlus related topics: Anemia

Drug Information available for: Epoetin alfa Erythropoietin Epoetin beta

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study of the Effect of Long-Term Mircera on Hemoglobin Levels in Patients With Chronic Renal Anemia

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Hb concentration over time [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Vital signs, AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	1800
Study Start Date:	September 2004
Estimated Study Completion Date:	February 2010

Arms	Assigned Interventions
1: Placebo Comparator	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Stable maintenance therapy s.c. or i.v. every 2 or 4 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 anemia;
currently receiving Mircera as part of a clinical study.

Exclusion Criteria:

women who are pregnant, breastfeeding or using unreliable birth control methods;
administration of another investigational drug planned during the study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090753

Show 251 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BH18387
Study First Received:	September 3, 2004
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00090753
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Epoetin Alfa
Hematologic Diseases
Renal Insufficiency, Chronic

Anemia
Kidney Failure, Chronic
Kidney Diseases

ClinicalTrials.gov processed this record on January 14, 2009