A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.

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

This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (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 subcutaneous (sc) 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 intravenous (iv) Mircera at a starting dose based on their previous (sc) dose, and those in the control group will receive weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.

Study Overview

• Status: Terminated
• Conditions: Anemia
• Intervention / Treatment: Drug: methoxy polyethylene glycol-epoetin beta; Drug: epoetin alfa; Drug: darbepoetin alfa

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
    • Mobile, Alabama, United States
  • Arizona
    • Phoenix, Arizona, United States
  • Arkansas
    • El Dorado, Arkansas, United States
    • Hot Springs, Arkansas, United States
  • California
    • Bakersfield, California, United States
    • Glendale, California, United States
    • Granada Hills, California, United States, 91344
    • Los Angeles, California, United States
    • Orange, California, United States
    • Palm Springs, California, United States
    • Riverside, California, United States
    • San Diego, California, United States
    • Yuba City, California, United States
  • Colorado
    • Colorado Springs, Colorado, United States
    • Lakewood, Colorado, United States
  • Connecticut
    • Stamford, Connecticut, United States
  • Florida
    • Miami, Florida, United States
    • Ocala, Florida, United States
    • Orlando, Florida, United States
    • Palm Beach Gardens, Florida, United States
    • Pembroke Pines, Florida, United States
    • Tampa, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
    • Augusta, Georgia, United States
    • Macon, Georgia, United States
  • Idaho
    • Meridan, Idaho, United States, 83642
  • Illinois
    • Evergreen Park, Illinois, United States
  • Indiana
    • Fort Wayne, Indiana, United States
  • Kansas
    • Wichita, Kansas, United States
  • Louisiana
    • Baton Rouge, Louisiana, United States
    • Shreveport, Louisiana, United States
  • Maryland
    • Germantown, Maryland, United States
  • Massachusetts
    • Boston, Massachusetts, United States
    • Springfield, Massachusetts, United States
  • Michigan
    • Detroit, Michigan, United States
    • Milwaukee, Michigan, United States
    • Royal Oak, Michigan, United States
  • Mississippi
    • Columbus, Mississippi, United States
  • Missouri
    • St Louis, Missouri, United States
  • Nebraska
    • Omaha, Nebraska, United States
  • New Jersey
    • Voorhees, New Jersey, United States
    • West Orange, New Jersey, United States, 07052
  • New York
    • Bronx, New York, United States
    • Brooklyn, New York, United States
    • Buffalo, New York, United States
    • Flushing, New York, United States
    • Great Neck, New York, United States
    • Mineola, New York, United States
    • Springfield Gardens, New York, United States
    • Syracuse, New York, United States
  • North Carolina
    • Durham, North Carolina, United States
    • Greenville, North Carolina, United States
    • Raleigh, North Carolina, United States
    • Winston-Salem, North Carolina, United States
  • Ohio
    • Maimisburg, Ohio, United States
    • Toledo, Ohio, United States
  • Oregon
    • Portland, Oregon, United States
  • Pennsylvania
    • Erie, Pennsylvania, United States
    • Lewistown, Pennsylvania, United States
    • Philadelphia, Pennsylvania, United States
    • Pittsburgh, Pennsylvania, United States
  • Rhode Island
    • Providence, Rhode Island, United States
  • South Carolina
    • Columbia, South Carolina, United States
    • Greenville, South Carolina, United States
    • Orangeburg, South Carolina, United States
  • Tennessee
    • Chattanooga, Tennessee, United States
    • Dyersburg, Tennessee, United States
  • Texas
    • Houston, Texas, United States, 77024
    • San Antonio, Texas, United States
    • Temple, Texas, United States
  • Virginia
    • Alexandria, Virginia, United States
    • Fairfax, Virginia, United States
    • Richmond, Virginia, United States
    • Salem, Virginia, United States
  • West Virginia
    • Bluefield, West Virginia, United States
    • Morgantown, West Virginia, United States
  • Wisconsin
    • Appleton, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients, >=18 years of age;
• chronic kidney disease stage IV not requiring dialysis;
• expected to initiate dialysis within 18 months;
• 15<=Glomerular Filtration Rate (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: methoxy polyethylene glycol-epoetin beta; 120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.	Drug: methoxy polyethylene glycol-epoetin beta; Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in a 1-mL prefilled syringe containing 0.3 mL or 0.6 mL solution. The methoxy polyethylene glycol-epoetin beta injectable solution was formulated in sodium phosphate, sodium sulfate, mannitol, methionine and poloxamer 188, pH 6.2 and did not contain any preservative. Participants received methoxy polyethylene glycol-epoetin beta subcutaneous once a month.; Other Names: Mircera
Active Comparator: Epoetin alfa; Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.	Drug: epoetin alfa; Standard of care as prescribed, per individual participant, subcutaneous once per week. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Active Comparator: Darbepoetin alfa; Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.	Drug: darbepoetin alfa; Standard of care as prescribed, per individual participant, darbepoetin alfa subcutaneous once every two weeks. Subcutaneous injections were to be administered in the same part of the body (ie, thigh,abdomen or arm) throughout the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL	Efficacy analyses were not performed.	6-7 months post initiation of dialysis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Adjustments	Efficacy analyses were not performed.	5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end.
Number of Participants Assessed for AEs and SAEs	The adverse events are captured in the adverse event and serious adverse event section of this database.	First dose of medication through 15 days post last dose (up to 8 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: March 29, 2007
• First Submitted That Met QC Criteria: March 29, 2007
• First Posted (Estimate): March 30, 2007

Study Record Updates

• Last Update Posted (Estimate): December 16, 2011
• Last Update Submitted That Met QC Criteria: November 14, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematinics; Epoetin Alfa; Darbepoetin alfa
• Other Study ID Numbers: ML20337