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A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

12. august 2016 oppdatert av: Hoffmann-La Roche

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once- Monthly Administration of Subcutaneous CERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anemia

This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 individuals.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

202

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Marokko
      • Agadir, Marokko, 70000
      • Casablanca, Marokko, 20100
      • Casablanca, Marokko, 20000
      • Casablanca, Marokko, 21000
      • FÉS, Marokko, 30000
      • Khouribga, Marokko, 23000
      • Marrakech, Marokko, 40000
      • Méknés, Marokko, 50300
      • Rabat, Marokko, 10150
      • Rabat, Marokko, 62001
      • Salé, Marokko, 15045
      • Tanger, Marokko, 90000

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 renal anemia;
  • regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months;
  • continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • active malignant disease (except non-melanoma skin cancer).

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: C.E.R.A.
Eligible participants will be administered continuous erythropoietin receptor activator (C.E.R.A.[Mircera]) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of 120, 200, or 360 micrograms (mcg) will be based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin (Hb) within a range of +/- 1.0 grams per deciliter (g/dL) of the reference hemoglobin (Hb) concentration and between 10.50 and 12.50 g/dL.
Legemiddel: methoxy polyethylene glycol-epoetin beta [Mircera]
Subcutaneous injection every 4 weeks (starting dose of 120, 200 or 360 micrograms, based on previous ESA therapy)
Andre navn:
  • C.E.R.A.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period
Tidsramme: EEP (Week 17 to Week 24)
The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.
EEP (Week 17 to Week 24)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period
Tidsramme: SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24)
Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP.
SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24)
Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP
Tidsramme: EEP (Week 17 to Week 24)
Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24.
EEP (Week 17 to Week 24)
Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP
Tidsramme: EEP (Week 17 to Week 24)
Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24.
EEP (Week 17 to Week 24)
Number of Participants With Any Adverse Events or Serious Adverse Events
Tidsramme: Up to Week 52
An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly.
Up to Week 52
Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP
Tidsramme: DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24)
Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either > or = 13 g/dL or < or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was > or =2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was >1 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.
DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24)
Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase
Tidsramme: Up to Week 52
Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported.
Up to Week 52
Mean Hemoglobin Levels Over Time
Tidsramme: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Hematocrit Levels Over Time
Tidsramme: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
The hematocrit (HCT) levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Albumin Levels Over Time
Tidsramme: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
The albumin levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean White Blood Cells and Thrombocytes Over Time
Tidsramme: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
The white blood cells (WBCs) and thrombocyte levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Phosphate and Potassium Levels Over Time
Tidsramme: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
The phosphate and potassium levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Tidsramme: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
The mean creatinine, iron, and total iron binding capacity (TIBC) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean C-Reactive Protein Levels Over Time
Tidsramme: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
The mean C-Reactive Protein (CRP) Levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Ferritin Levels Over Time
Tidsramme: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
The mean ferritin levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Transferrin Saturation Levels Over Time
Tidsramme: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
The mean transferrin saturation (TSAT) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Pulse Rate Over Time
Tidsramme: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean change in pulse rate was defined as the difference between mean pulse rate at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).
Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Blood Pressure Over Time
Tidsramme: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean change in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) before and after dialysis was defined as the difference between mean blood pressure at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).
Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Weight Over Time
Tidsramme: Week 16 and Week 48
Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48).
Week 16 and Week 48

Samarbeidspartnere og etterforskere

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

Sponsor

Hoffmann-La Roche

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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. februar 2009

Primær fullføring (Faktiske)

1. oktober 2010

Studiet fullført (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først innsendt

17. februar 2009

Først innsendt som oppfylte QC-kriteriene

15. april 2009

Først lagt ut (Anslag)

16. april 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

7. oktober 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. august 2016

Sist bekreftet

1. august 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ML21797

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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