A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00081471

Purpose

This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-Label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-Dialysis Patients With Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Anemia Dialysis Kidney Failure

Drug Information available for: Epoetin beta Darbepoetin alfa

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Hemoglobin response rate [ Time Frame: Weeks 1-28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	324
Study Completion Date:	July 2006

Arms	Assigned Interventions
Experimental: 1	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 0.6 micrograms/kg sc (starting dose) once every 2 weeks
Active Comparator: 2	Drug: darbepoetin alfa 0.45 micrograms/kg sc (starting dose) weekly

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 kidney disease;
anemia;
not on dialysis therapy;
not receiving epoetin.

Exclusion Criteria:

women who are pregnant, breastfeeding or using unreliable birth control methods;
administration of another investigational drug within 4 weeks before screening, or during the study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081471

Show 98 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00081471 History of Changes
Other Study ID Numbers:	BA16738
Study First Received:	April 13, 2004
Last Updated:	May 13, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases

Renal Insufficiency
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012