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A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis

14. januar 2016 opdateret af: Hoffmann-La Roche
An observational, longitudinal, multi-center, non-interventional study in participants with chronic kidney disease (CKD) stage 3-4, assessed by Modification of Diet in Renal Disease (MDRD) to collect data regarding safety and efficacy in participants with pre-dialysis situation who are treated with MIRCERA in normal clinical environment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

144

Kontakter og lokationer

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

Studiesteder

  • Sverige
      • Angeholm, Sverige, S-262 81
      • Bollnas, Sverige, 821 81
      • Eskilstuna, Sverige, 63188
      • Gaevle, Sverige, 80187
      • Goeteborg, Sverige, 41345
      • Gothenburg, Sverige, S-402 76
      • Huddinge, Sverige, 14186
      • Jonkoping, Sverige, 55185
      • Karlshamn, Sverige, S-374 80
      • Karlstad, Sverige, 65185
      • Kristianstad, Sverige, 29185
      • Linkoeping, Sverige, S-581 85
      • Mölndal, Sverige, S-431 80
      • Norrkoeping, Sverige, 60182
      • Skövde, Sverige, 54185
      • Stockholm, Sverige, 17176
      • Stockholm, Sverige, 18288
      • Umea, Sverige, 90185
      • Värnamo, Sverige, 33185
      • Västervik, Sverige, 59381

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult participants with CKD Stage 3-4 treated with MIRCERA

Beskrivelse

Inclusion Criteria:

  • Adult participants above 18 years of age
  • Pre-dialysis participants with CKD stage 3-4 treated with MIRCERA and continue in the pre-dialysis state for the whole study period
  • Estimated glomerular filteration rate (e-GFR) between 15-60 milliliter per minute (mL/min) (calculated)

Exclusion Criteria:

  • Participants involved in interventional trials
  • Participants with life expectancy less than 1 year
  • Active malignancy
  • Planned living kidney transplant within 6 months.

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
Intervention / Behandling
Cohort of CKD Participants
Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
Andet: MIRCERA

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Reaching a Hemoglobin (Hb) Value of Greater Than (>) 100 and Less Than (<) 120 Grams Per Liter (gm/L) at Month 6 Before Inclusion
Tidsramme: Pre-baseline (Month -6)
Pre-baseline (Month -6)
Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion
Tidsramme: Pre-baseline (Month -3)
Pre-baseline (Month -3)
Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline
Tidsramme: Baseline
Baseline
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion
Tidsramme: Month 3
Month 3
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion
Tidsramme: Month 6
Month 6
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion
Tidsramme: Month 9
Month 9
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion
Tidsramme: Month 12
Month 12
Mean Hb Value at Month 6 Before Inclusion
Tidsramme: Pre-baseline (Month -6)
Pre-baseline (Month -6)
Mean Hb Value at Month 3 Before Inclusion
Tidsramme: Pre-baseline (Month -3)
Pre-baseline (Month -3)
Mean Hb Value at Baseline
Tidsramme: Baseline
Baseline
Mean Hb Value at Month 3 After Inclusion
Tidsramme: Month 3
Month 3
Mean Hb Value at Month 6 After Inclusion
Tidsramme: Month 6
Month 6
Mean Hb Value at Month 9 After Inclusion
Tidsramme: Month 9
Month 9
Mean Hb Value at Month 12 After Inclusion
Tidsramme: Month 12
Month 12
Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline
Tidsramme: Pre-baseline (Month -6) to Baseline
Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.
Pre-baseline (Month -6) to Baseline
Percentage of Participants With Hb Fluctuation From Baseline to Month 12
Tidsramme: Baseline to Month 12
Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.
Baseline to Month 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Change in MIRCERA Treatment
Tidsramme: Months 3, 6, 9, and 12
Change in MIRCERA treatment included changes in dose, frequency, and route of administration.
Months 3, 6, 9, and 12
Percentage of Participants With Number of MIRCERA Dose Changes
Tidsramme: Baseline to Month 12
Baseline to Month 12
Correlation of Hb Levels With Underlying Disease
Tidsramme: Baseline to 12 months
Baseline to 12 months
Correlation of Hb Levels With Levels of Inflammation
Tidsramme: Baseline to 12 months
Baseline to 12 months
Percentage of Participants With Changes in Iron Supplement
Tidsramme: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of participants who had any change in their iron supplement medication at a specified visit were reported.
Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of Participants With Changes in Immunosuppressive Treatment
Tidsramme: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of participants who had any change in their immunosuppressive medication at a specified visit were reported.
Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of Participants With Changes in AntihypertensiveTreatment
Tidsramme: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of participants who had any change in their antihypertensive medication at a specified visit were reported.
Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Number of Participants With Different Medication Treatment
Tidsramme: Pre-baseline (Month -6) to Month 12
Number of participants who were receiving different treatments (antihypertensive, immunosuppressive, iron supplements, and others) before and/or after baseline were reported. Same participant could be reported in more than one category.
Pre-baseline (Month -6) to Month 12
Percentage of Participants Who Required Blood Transfusion
Tidsramme: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of Participants Who Required Renal Replacement Therapy
Tidsramme: Months 3, 6, 9, and 12
Renal replacement therapy was defined as hemodialysis and peritoneal dialysis.
Months 3, 6, 9, and 12

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 2009

Primær færdiggørelse (Faktiske)

1. april 2011

Studieafslutning (Faktiske)

1. april 2011

Datoer for studieregistrering

Først indsendt

28. september 2015

Først indsendt, der opfyldte QC-kriterier

30. september 2015

Først opslået (Skøn)

2. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ML22439

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 MIRCERA

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Georgia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner