Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Efficacy and Safety of Peginesatide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Participants Previously Treated With Epoetin.

13. august 2012 opdateret af: Takeda

A Phase 2 Study of the Safety and Efficacy of Hematide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Subjects Previously Treated With Epoetin

The purpose of this study is to determine the efficacy and safety of peginesatide injection for maintenance treatment of anemia in participants on peritoneal dialysis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

According to the International Federation of Renal Registries, in 1999 the prevalence of peritoneal dialysis in the United States as approximately 9.5% of patients receiving dialysis (2005 United States Renal Data Systems data indicates a prevalence of around 7.5%). Data from Europe in 1999 to 2000 (not including the United Kingdom, France or Germany) indicated peritoneal dialysis was the mode of dialysis in approximately 11.1% of dialysis patients. 2006 data from the United Kingdom indicates that more than 20% of patients on dialysis are receiving peritoneal dialysis while French and German data indicate rates of 8.1% and 4.8% respectively. More than 90% of patients with chronic renal failure/chronic kidney disease Stage 5 (End Stage Renal Disease) are anemic. The vast majority of patients receiving hemodialysis or peritoneal dialysis receive erythropoiesis-stimulating agent therapy to treat their anemia.

Anemia of chronic renal failure is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors also include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The prevalence of anemia increases with progressive deterioration of renal function, and affects more than 90% of patients with chronic kidney disease (CKD) Stage 5 (End Stage Renal Disease). Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function and exercise capacity, increased left ventricular hypertrophy and heart failure. Treatment of anemia reduces morbidity and mortality risks and may improve quality of life.

Erythropoiesis stimulating agents have been established as a treatment for anemia in chronic renal failure participants, and have improved the management of anemia over alternatives such as transfusion. Peginesatide (hematide) is a parenteral formulation being developed for the correction of anemia in patients with chronic renal failure, and binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents.

Participants in this study received variable doses of peginesatide injection once every four weeks. Total commitment time for this study was about 29 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

59

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Australien
    • New South Wales
      • New Lambtom, New South Wales, Australien
  • Det Forenede Kongerige
    • England
      • London, England, Det Forenede Kongerige
  • Forenede Stater
    • California
      • Azusa, California, Forenede Stater
      • Los Angeles, California, Forenede Stater
      • Whittier, California, Forenede Stater
    • Florida
      • Naples, Florida, Forenede Stater
    • Georgia
      • Decatur, Georgia, Forenede Stater
    • Illinois
      • Evergreen Park, Illinois, Forenede Stater
    • Kansas
      • Wichita, Kansas, Forenede Stater
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater
      • New Iberia, Louisiana, Forenede Stater
      • Shreveport, Louisiana, Forenede Stater
    • Mississippi
      • Columbus, Mississippi, Forenede Stater
      • Tupelo, Mississippi, Forenede Stater
    • New York
      • New York, New York, Forenede Stater
      • Williamsville, New York, Forenede Stater
    • Ohio
      • Canton, Ohio, Forenede Stater
    • Texas
      • Arlington, Texas, Forenede Stater
      • Tyler, Texas, Forenede Stater
    • Virginia
      • Fairfax, Virginia, Forenede Stater
      • Mechanicsville, Virginia, Forenede Stater
  • Italien
      • Modena, Italien
  • New Zealand
      • Dunedin, New Zealand

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 til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. The patient was a man or woman and 18 to 90 years of age, inclusive.
  2. The patient had CKD and had been on peritoneal dialysis for ≥3 months before enrollment.
  3. The patient was on stable SC epoetin (alfa or beta) maintenance therapy continuously prescribed for a minimum of 8 weeks prior to enrollment.
  4. The patient had 4 consecutive Hb values with a mean ≥10.0 and ≤12.0 g/dL during the screening period, with the difference between the mean of the first confirmed (2 consecutive) Hb values and the mean of the last confirmed (2 consecutive) Hb values being ≤1.0 g/dL.
  5. The patient had 1 ferritin level ≥100 ng/mL within 4 weeks before enrollment.

Exclusion Criteria:

  1. The patient had known bleeding or coagulation disorder.
  2. The patient had known hematologic disease or cause of anemia other than renal disease (e.g., pure red cell aplasia, homozygous sickle-cell disease, thalassemia, multiple myeloma, hemolytic anemia, and myelodysplastic syndrome).
  3. The patient had received a recent course of intensive iron replacement (i.e., more than 500 mg IV in the 28 days before enrollment).
  4. The patient had advanced chronic congestive heart failure defined by New York Heart Association Class III or IV.
  5. The patient had a known history of seizure disorder or received antiepileptic medication for a seizure disorder within 6 months before enrollment.
  6. The patient had a scheduled kidney transplant. (Note: patients who were currently on a transplant waiting list were not excluded unless there was an identified donor).

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Peginesatid
Medicin: Peginesatide
Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
Andre navne:
  • Omontys
  • Hæmatid
  • AF37702

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Tidsramme: Baseline and Week 20 to Week 25.
The primary efficacy endpoint was the mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to Enrollment and the hemoglobin on the day of Enrollment) and the Evaluation Period (mean hemoglobin from Weeks 20 to 25).
Baseline and Week 20 to Week 25.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period
Tidsramme: Week 20 to Week 25.

Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Week 20 to Week 25). The target hemoglobin range was 10.0 to 12.0 g/dL.

The 95% confidence interval was calculated from the normal approximation with continuity correction.
Week 20 to Week 25.
Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL
Tidsramme: Baseline and Week 20 to Week 25.
Percentage of participants with a mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from measured at Weeks 20 to 25) of less than or equal ± 1 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction.
Baseline and Week 20 to Week 25.
Percentage of Participants With Red Blood Cell Transfusions
Tidsramme: Up to 25 weeks.
The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 1 - 19) and Evaluation Period (Weeks 20 -25). 95% Confidence Intervals were calculated from the normal approximation with continuity correction. One patient had the last study visit during the titration period and the transfusion after the titration period. This patient is excluded from the summary of evaluation period.
Up to 25 weeks.
Mean Hemoglobin During 4-week Intervals
Tidsramme: Up to 25 weeks.
Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 1-19) and weekly during the Evaluation Period (Weeks 20-25). One patient did not have central lab hemoglobin value during a regularly scheduled visit during weeks 2-5.
Up to 25 weeks.
Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals
Tidsramme: Up to 25 weeks.
Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 1-19) and weekly during the Evaluation Period (Weeks 20-25). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.
Up to 25 weeks.
Percentage of Participants With Dose Adjustments During the Study
Tidsramme: From Week 4 to Week 25
The peginesatide dose was adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 1-19) and Evaluation Period (Weeks 20-25). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was >20% higher or >20% lower respectively, than the previous dose.
From Week 4 to Week 25

Samarbejdspartnere og efterforskere

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

Sponsor

Takeda

Samarbejdspartnere

Affymax

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. oktober 2008

Primær færdiggørelse (Faktiske)

1. maj 2010

Studieafslutning (Faktiske)

1. maj 2010

Datoer for studieregistrering

Først indsendt

11. september 2008

Først indsendt, der opfyldte QC-kriterier

12. september 2008

Først opslået (Skøn)

15. september 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. august 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. august 2012

Sidst verificeret

1. august 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AFX01_201
  • 2008-003458-13 (EudraCT nummer)
  • U1111-1114-0301 (Registry Identifier: WHO)

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 .

Kliniske forsøg med Peginesatide

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ukraine

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner