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

14. november 2011 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

111

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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 navn:
  • 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.
Legemiddel: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hoffmann-La Roche

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2007

Primær fullføring (Faktiske)

1. februar 2008

Studiet fullført (Faktiske)

1. februar 2008

Datoer for studieregistrering

Først innsendt

29. mars 2007

Først innsendt som oppfylte QC-kriteriene

29. mars 2007

Først lagt ut (Anslag)

30. mars 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

16. desember 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. november 2011

Sist bekreftet

1. november 2011

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ML20337

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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