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An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia

13. juni 2017 opdateret af: Hoffmann-La Roche

Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients on Dialysis , Treated According to Routine Clinical Practice

This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

127

Kontakter og lokationer

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

Studiesteder

  • Indien
      • Ahmedabad, Indien, 380005
        • Ahmedabad Dialysis Centre
      • Guwahati, Indien, 781007
        • Excel Center
      • Kolkata, Indien, 600054
        • ESIS Hospital; Department of Nephrology
      • Mumbai, Indien, 400083
        • Vertex Hospital
      • New Delhi, Indien, 110076
        • Apollo Indraprastha Hospitals; Nephrology
      • Pune, Indien, 411033
        • Aditya Birla Memorial Hospital
    • Delhi
      • New Delhi, Delhi, Indien, 110060
        • Sir Gangaram Hospital

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients with chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia

Beskrivelse

Inclusion Criteria:

  • Adult patients, 18 to 65 years of age, inclusive
  • Patients with chronic kidney disease on dialysis
  • ESA naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
  • Adequate irons status as judged by the treating physician

Exclusion Criteria:

  • Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
  • Clinically significant concomitant disease or disorder as defined by protocol
  • Clinical suspicion of pure red cell aplasia (PRCA)
  • Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
  • Transfusion of red blood cells in the previous 2 months
  • Pregnant women
  • Contraindications for Mircera according to local prescribing information or as judged by the investigator

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Kohorte

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Age of Participants Treated With C.E.R.A
Tidsramme: Baseline (Week 0)
Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25
Baseline (Week 0)
Mean Weight of Participants Treated With C.E.R.A
Tidsramme: Baseline (Week 0)
Weight of the participants was measured at the Baseline and summarized with descriptive statistics.
Baseline (Week 0)
Number of Participants With Co-morbidity Treated With C.E.R.A
Tidsramme: Up to Week 24
Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.
Up to Week 24
Mean Time Required to Achieve Target Hemoglobin Range
Tidsramme: Up to Week 24
The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1
Up to Week 24
Percentage of Participants Achieved Target Range of Hemoglobin
Tidsramme: Up to Week 24
The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.
Up to Week 24
Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.
Tidsramme: Up to Week 24
Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.
Up to Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study
Tidsramme: Up to Week 24
For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.
Up to Week 24
Mean Time Spent by Participants in the Hb Target Range
Tidsramme: Up to Week 24
Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.
Up to Week 24
Evaluation of Route of Administration for C.E.R.A
Tidsramme: Up to Week 24
C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.
Up to Week 24
Evaluation of Dose Per Injection of C.E.R.A
Tidsramme: Up to Week 24
The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.
Up to Week 24
Number of Participants Received Concomitant Medications
Tidsramme: Up to Week 24
Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.
Up to Week 24

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 (Faktiske)

30. april 2011

Primær færdiggørelse (Faktiske)

30. september 2013

Studieafslutning (Faktiske)

30. september 2013

Datoer for studieregistrering

Først indsendt

30. august 2012

Først indsendt, der opfyldte QC-kriterier

30. august 2012

Først opslået (Skøn)

3. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juni 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML25475

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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Betingelser

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