A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.



Status:Terminated
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2007
End Date:April 2008

Use our guide to learn which trials are right for you!

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

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.


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.
We found this trial at
62
sites
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Alexandria, VA
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Bluefield, WV
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Brandon, FL
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Dyersburg, TN
Click here to add this to my saved trials
?
mi
from
Eatontown, NJ
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
?
mi
from
Evergreen Park, IL
Click here to add this to my saved trials
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
?
mi
from
Flushing, NY
Click here to add this to my saved trials
?
mi
from
Hot Springs, AR
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Kansas, KS
Click here to add this to my saved trials
?
mi
from
Lafayette, LA
Click here to add this to my saved trials
?
mi
from
Lakewood, CO
Click here to add this to my saved trials
?
mi
from
Lewistown, PA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Macon, GA
Click here to add this to my saved trials
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Mountain View, California 94040
?
mi
from
Mountain View, CA
Click here to add this to my saved trials
New Brunswick, New Jersey 08901
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
?
mi
from
Ocala, FL
Click here to add this to my saved trials
?
mi
from
Orangeburg, SC
Click here to add this to my saved trials
?
mi
from
Orchard Park, NY
Click here to add this to my saved trials
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Pontiac, MI
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Riverside, CA
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
San Leandro, CA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Simi Valley, CA
Click here to add this to my saved trials
Springfield, Massachusetts 01199
?
mi
from
Springfield, MA
Click here to add this to my saved trials
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
?
mi
from
Stamford, CT
Click here to add this to my saved trials
?
mi
from
Sumter, SC
Click here to add this to my saved trials
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
?
mi
from
Temple, TX
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
?
mi
from
Tyler, TX
Click here to add this to my saved trials
?
mi
from
West Orange, NJ
Click here to add this to my saved trials
?
mi
from
Whittier, CA
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials
?
mi
from
Williamsville, NY
Click here to add this to my saved trials
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
?
mi
from
Yuba City, CA
Click here to add this to my saved trials