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

14. november 2011 opdateret af: Hoffmann-La Roche

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

111

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Andre navne:
  • Mircera
Aktiv komparator: 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.
Medicin: 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.
Aktiv komparator: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL
Tidsramme: 6-7 months post initiation of dialysis
Efficacy analyses were not performed.
6-7 months post initiation of dialysis

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose Adjustments
Tidsramme: 5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end.
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
Tidsramme: First dose of medication through 15 days post last dose (up to 8 months)
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2007

Primær færdiggørelse (Faktiske)

1. februar 2008

Studieafslutning (Faktiske)

1. februar 2008

Datoer for studieregistrering

Først indsendt

29. marts 2007

Først indsendt, der opfyldte QC-kriterier

29. marts 2007

Først opslået (Skøn)

30. marts 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. december 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. november 2011

Sidst verificeret

1. november 2011

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML20337

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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