A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients. - Full Text View

Purpose

This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomized either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dL. 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] Drug: Epoetin alfa	Phase 3

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 to Compare the Effect of Monthly Injections of Mircera Versus Epoetin Alfa on Hemoglobin Levels in Peritoneal Dialysis Patients Who Self-inject or Receive In-center Injections

Resource links provided by NLM:

MedlinePlus related topics: Anemia Dialysis

Drug Information available for: Polyethylene Erythropoietin Polyethylene glycol Epoetin Alfa

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Change in Hb concentration between baseline and average during evaluation period [ Time Frame: Months 7-9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Vital signs, AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment:	80
Study Start Date:	February 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 120-360 micrograms sc monthly, starting dose
Active Comparator: 2	Drug: Epoetin alfa As prescribed, sc

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 stage V;
on peritoneal dialysis for 3 months prior to screening;
on epoetin alfa sc >=3 months prior to screening.

Exclusion Criteria:

patients expecting to change dialysis modality over course of study;
patients hospitalized during previous 3 months for any clinically significant condition;
active malignancy;
bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening;
transfusion of red blood cells within 3 months prior to screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442416

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Locations

United States, Alabama

Birmingham, Alabama, United States, 35213
United States, Arizona

Phoenix, Arizona, United States, 85012
United States, Arkansas

Hot Springs, Arkansas, United States, 71901
United States, California

Bakersfield, California, United States, 93309

Los Angeles, California, United States, 90033

Los Angeles, California, United States, 90048

Mountain View, California, United States, 94040

Riverside, California, United States, 92501

San Diego, California, United States, 92120

San Leandro, California, United States, 94578

Simi Valley, California, United States, 93065

Whittier, California, United States, 90602

Yuba City, California, United States, 95991
United States, Colorado

Lakewood, Colorado, United States, 80260
United States, Connecticut

Stamford, Connecticut, United States, 06902
United States, Florida

Brandon, Florida, United States, 33511

Ocala, Florida, United States, 34471

Pembroke Pines, Florida, United States, 33028
United States, Georgia

Augusta, Georgia, United States, 30309

Macon, Georgia, United States, 31201

Marietta, Georgia, United States, 30060
United States, Illinois

Evanston, Illinois, United States, 60201

Evergreen Park, Illinois, United States, 60805
United States, Kansas

Kansas City, Kansas, United States, 66160

Wichita, Kansas, United States, 67214
United States, Louisiana

Baton Rouge, Louisiana, United States, 70884

Lafayette, Louisiana, United States, 70503
United States, Massachusetts

Boston, Massachusetts, United States, 02215

Springfield, Massachusetts, United States, 01107
United States, Michigan

Detroit, Michigan, United States, 48236

Pontiac, Michigan, United States, 48341
United States, Missouri

St. Louis, Missouri, United States, 63110
United States, New Jersey

Eatontown, New Jersey, United States, 07724

New Brunswick, New Jersey, United States, 08901

West Orange, New Jersey, United States, 07052
United States, New York

Flushing, New York, United States, 11355

Orchard Park, New York, United States, 14127

Syracuse, New York, United States, 13212

Williamsville, New York, United States, 14221
United States, North Carolina

Raleigh, North Carolina, United States, 27609

Winston-salem, North Carolina, United States, 27103
United States, Ohio

Dayton, Ohio, United States, 45405

Toledo, Ohio, United States, 43606
United States, Oklahoma

Tulsa, Oklahoma, United States, 74120
United States, Pennsylvania

Lewistown, Pennsylvania, United States, 17044

Philadelphia, Pennsylvania, United States, 19106

Philadelphia, Pennsylvania, United States, 19144
United States, South Carolina

Orangeburg, South Carolina, United States, 29118

Sumter, South Carolina, United States, 29150
United States, Tennessee

Chattanooga, Tennessee, United States, 37404

Dyersburg, Tennessee, United States, 38024
United States, Texas

Arlington, Texas, United States, 76015

Austin, Texas, United States, 78705

Corpus Christi, Texas, United States, 78404

Dallas, Texas, United States, 75390

Houston, Texas, United States, 77030

San Antonio, Texas, United States, 78215

San Antonio, Texas, United States, 78229

Temple, Texas, United States, 76501

Tyler, Texas, United States, 75701
United States, Virginia

Alexandria, Virginia, United States, 22304

Fairfax, Virginia, United States, 22033

Fairfax, Virginia, United States, 22030

Richmond, Virginia, United States, 23229
United States, Washington

Seattle, Washington, United States, 98133
United States, West Virginia

Bluefield, West Virginia, United States, 24701

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:	NCT00442416 History of Changes
Other Study ID Numbers:	ML20338
Study First Received:	March 1, 2007
Last Updated:	September 4, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013