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Trial information
A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.
Status: Terminated
Protocol number: ML20337
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study of the effect of intravenous Mircera on hemoglobin control in patients transitioning from chronic kidney disease stage 4 through dialysis
Brief summary: This 2 arm study will assess the efficacy and safety of Mircera in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients will be randomized either to receive Mircera or to remain on their existing therapy; the initial monthly dose of s.c. Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation of dialysis, patients in the Mircera group will receive monthly iv Mircera at a starting dose based on their previous s.c. dose, and those in the control group will receive weekly i.v. epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals. Target sample size is 2121.
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][Mircera]
Primary outcome: 1. Percentage of patients able to maintain Hb within 10-12g/dL Time frame: 6-7 months post initiation of dialysis
Key secondary outcomes: 1. Dose adjustments Time frame: 5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end.
2. AEs, laboratory parameters, iron parameters Time frame: Throughout study
Inclusion criteria: - adult patients, >=18 years of age;
- chronic kidney disease stage IV not requiring dialysis;
- expected to initiate dialysis within 18 months;
- 15<=GFR<=29.
Exclusion criteria: - failing renal allograft in place;
- acute or chronic bleeding within 8 weeks prior to screening;
- transfusion of red blood cells within 8 weeks prior to screening;
- poorly controlled hypertension;
- immunosuppressive therapy in the 12 weeks prior to screening.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 03/29/2007
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:United States - Birmingham, AL
- Mobile, AL
- Phoenix, AZ
- El Dorado, AR
- Hot Springs, AR
- Bakersfield, CA
- Glendale, CA
- Granada Hills, CA
- Los Angeles, CA
- Orange, CA
- Palm Springs, CA
- Riverside, CA
- San Diego , CA
- Yuba City, CA
- Colorado Springs, CO
- Lakewood, CO
- Stamford, CT
- Miami, FL
- Ocala, FL
- Orlando, FL
- Palm Beach Gardens, FL
- Tampa, FL
- Atlanta, GA
- Augusta, GA
- Macon , GA
- Evergreen Park, IL
- Fort Wayne, IN
- Wichita, KS
- Baton Rouge, LA
- Shreveport, LA
- Germantown, MD
- Boston, MA
- Springfield, MA
- Detroit, MI
- Royal Oak, MI
- Columbus, MS
- St Louis, MO
- Omaha, NE
- Voorhees, NJ
- West Orange, NJ
- Bronx, NY
- Brooklyn, NY
- Flushing, NY
- Great Neck, NY
- Mineola, NY
- Springfield Gardens, NY
- Syracuse, NY
- Durham, NC
- Greenville, NC
- Raleigh, NC
- Winston Salem, NC
- Miamisburg, OH
- Toledo, OH
- Portland, OR
- Salem, OR
- Erie, PA
- Philadelphia, PA
- Pittsburgh, PA
- Providence, RI
- Columbia, SC
- Greenville, SC
- Orangeburg, SC
- Chattanooga, TN
- Dyersburg, TN
- Houston, TX
- Lewisville, TX
- San Antonio, TX
- Temple, TX
- Alexandria, VA
- Fairfax , VA
- Richmond, VA
- Bluefield, WV
- Morgantown, WV
- Appleton, WI
- Milwaukee, WI
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