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Trial information
A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.
Status: Terminated
Protocol number: ML20338
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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
Brief summary: 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. Target sample size is
80.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: methoxy polyethylene glycol-epoetin beta [Mircera]
Primary outcome: 1. Change in Hb concentration between baseline and average during evaluation period Time frame: Months 7-9
Key secondary outcomes: 1. Vital signs, AEs, laboratory parameters Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 03/07/2007
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:United States - Birmingham, AL
- Phoenix, AZ
- Hot Springs, AR
- Bakersfield, CA
- Los Angeles, CA
- Mountain View, CA
- Riverside, CA
- San Diego , CA
- San Leandro, CA
- Simi Valley, CA
- Whittier, CA
- Yuba City, CA
- Lakewood, CO
- Stamford, CT
- Brandon, FL
- Ocala, FL
- Pembroke Pines, FL
- Augusta, GA
- Macon , GA
- Marietta, GA
- Evanston, IL
- Evergreen Park, IL
- Kansas City, KS
- Wichita, KS
- Baton Rouge, LA
- Lafayette, LA
- Boston, MA
- Springfield, MA
- Detroit, MI
- Pontiac, MI
- St Louis, MO
- Eatontown, NJ
- New Brunswick, NJ
- West Orange, NJ
- Flushing, NY
- Orchard Park, NY
- Syracuse, NY
- Williamsville, NY
- Raleigh, NC
- Winston Salem, NC
- Dayton, OH
- Toledo, OH
- Tulsa , OK
- Lewistown, PA
- Philadelphia, PA
- Orangeburg, SC
- Sumter, SC
- Chatanooga, TN
- Dyersburg, TN
- Arlington, TX
- Austin, TX
- Corpus Christi, TX
- Dallas, TX
- Houston, TX
- San Antonio, TX
- Temple, TX
- Tyler, TX
- Alexandria, VA
- Fairfax , VA
- Richmond, VA
- Seattle, WA
- Bluefield, WV
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