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An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia

17. november 2015 opdateret af: Hoffmann-La Roche

Non-interventional Study to Investigate Hemoglobin Levels and Dose Over Time in the Daily Use of Mircera for Renal Anemia in Larger Centers, and to Detect Differences Between Standard of Care in the Centers

This observational study will investigate hemoglobin levels and Mircera (methoxy polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and compare standards of care between centers. Data from each patient will be collected over 12 months of Mircera therapy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1580

Kontakter og lokationer

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

Studiesteder

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

Sandsynlighedsprøve

Studiebefolkning

CKD patients treated with Mirecera at different medical centers

Beskrivelse

Inclusion Criteria:

  • adult patients, >/= 18 years of age
  • chronic kidney disease
  • informed consent for data transmission

Exclusion Criteria:

  • serious hematological or infectious disease
  • acute bleeding in the 16 weeks preceding data collection
  • participation in an interventional trial
  • female patients: pregnancy or breast-feeding

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
1
Medicin: methoxy polyethylene glycol-ep [Mircera]
As prescribed by physician

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range
Tidsramme: Month 0 to Month 12
Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (<) 10 g/dL or greater than (>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented.
Month 0 to Month 12
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Tidsramme: Month 0 to Month 12
The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (<65 years, greater than or equal to [>=] 65 years) and center size (>100 participants, less than or equal to [<=] 100 participants) is presented.
Month 0 to Month 12
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Tidsramme: Month 6 to Month 12
The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (<65 years, >=65 years) and center size (>100 participants, <=100 participants) is presented.
Month 6 to Month 12
Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size
Tidsramme: Month 0 to Month 12
For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values. Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (<65 years, >=65 years), and center size (>100 participants, <=100 participants) is presented. Data for this outcome measure was reported for overall participants.
Month 0 to Month 12
Serum Ferritin Values
Tidsramme: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants.
Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Serum Iron Values
Tidsramme: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants.
Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Transferrin Values
Tidsramme: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants.
Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Transferrin Saturation Values
Tidsramme: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Data for this outcome measure was reported for overall participants.
Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
C-reactive Protein (CRP) Values
Tidsramme: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for this outcome measure was reported for overall participants.
Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Number of Physicians Satisfied With Treatment at Final Visit
Tidsramme: Month 12 or early discontinuation
Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit. Physicians' responses were "very satisfied", "satisfied", "undecided", or "not satisfied". One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed. Data for this outcome measure was reported for overall participants.
Month 12 or early discontinuation
Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion
Tidsramme: Month 12 or early discontinuation
At final visit, physicians were asked to answer ("yes" or "no") the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion. Data for this outcome measure was reported for overall participants.
Month 12 or early discontinuation
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Tidsramme: Month 12 or early discontinuation
At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta. The same participant could have discontinued treatment due to multiple reasons. Data for this outcome measure was reported for overall participants.
Month 12 or early discontinuation
Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy
Tidsramme: Month 12 or early discontinuation
Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented. Data for this outcome measure was reported for overall participants.
Month 12 or early discontinuation
Number of Participants Satisfied With Treatment at Final Visit
Tidsramme: Month 12 or early discontinuation
Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit. Participants' responses were "very satisfied", "satisfied", "undecided", or "not satisfied". Data for this outcome measure was reported for overall participants.
Month 12 or early discontinuation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Tidsramme: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Average methoxy polyethylene glycol-epoetin beta dose per application is presented by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered. Data for this outcome measure was reported for overall participants.
Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 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. marts 2010

Primær færdiggørelse (Faktiske)

1. februar 2013

Studieafslutning (Faktiske)

1. februar 2013

Datoer for studieregistrering

Først indsendt

15. januar 2010

Først indsendt, der opfyldte QC-kriterier

15. januar 2010

Først opslået (Skøn)

18. januar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. november 2015

Sidst verificeret

1. november 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML22714

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 Anæmi

Kliniske forsøg med methoxy polyethylene glycol-ep [Mircera]

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Israel

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner