A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00048048

Purpose

This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

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

MedlinePlus related topics: Anemia

Drug Information available for: Epoetin beta

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label Study of the Effect of Different Dosing Intervals of Subcutaneous Mircera on Hemoglobin Level/Correction in Patients With Chronic Renal Anemia

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Hemoglobin levels [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hematocrit, reticulocyte count. Vital signs, adverse events, laboratory values [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	65
Study Completion Date:	March 2006

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
2: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
3: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
4: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
5: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
6: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
7: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
8: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
9: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration

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;
not receiving renal replacement therapy.

Exclusion Criteria:

women who are pregnant, breastfeeding or using unreliable birth control methods;
administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048048

Locations

United States, Alabama

BIRMINGHAM, Alabama, United States, 35211
United States, California

SAN DIEGO, California, United States, 92103-8342
United States, Michigan

DETROIT, Michigan, United States, 48202-2689

DETROIT, Michigan, United States, 48236
United States, Nevada

LAS VEGAS, Nevada, United States, 89106

RENO, Nevada, United States, 89434
United States, New York

MINEOLA, New York, United States, 11501
United States, Oregon

PORTLAND, Oregon, United States, 97201-2940
Canada, Alberta

EDMONTON, Alberta, Canada, T6G 2B7
Canada, British Columbia

VANCOUVER, British Columbia, Canada, V6Z 1Y6
Canada, Quebec

MONTREAL, Quebec, Canada, H3A 1A1
France

PARIS, France, 75018

COLMAR, France, 68024

PARIS, France, 75475
Mexico

MONTERREY, Mexico, 64710

MEXICO CITY, Mexico, 14000
Poland

WROCLAW, Poland, 50-417

GDANSK, Poland, 80-211

KRAKOW, Poland, 31-501
United Kingdom

LONDON, United Kingdom, SE22 8PT

BELFAST, United Kingdom, BT9 7LJ

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BA16528
Study First Received:	October 24, 2002
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00048048 History of Changes
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

Additional relevant MeSH terms:

Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on May 07, 2009