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Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera Hemodialysis Population (RETICERA)

3. marts 2022 opdateret af: University Hospital, Brest

Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera

Patients under hemodialysis treatment are mostly treated by erythropoietin (EPO) through erythropoiesis stimulating agents (ESA). The objective of ESA treatments is to maintain the hemoglobin level in a therapeutic target around 11g/dl. The EPO dose that is necessary to reach this target depends on numerous and imbricated factors such as age, associated pathologies, iron status, inflammation. As of today, there is no marker to predict the EPO response and Hemoglobin (Hb) level is currently the only and late tool to assess the efficacy.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

Reticulocytes are immature red blood cells that are temporary present in the blood circulation. They are easily monitored on every automatic dosing machines. Nevertheless, among the dialysis population, they are seldom used and attempt to define a normal reticulocyte level, attesting a correct medullar response to the administrated EPO dose failed due to the timing of blood collection (corresponding to the Nadir day of reticulocytosis).

In a preliminary study, it has shown that reticulocyte count kinetics depends on ESA's type, dose and administration frequency. Reticulocyte kinetics were compared in three groups of stable dialysis patients, depending on their ESA treatment. Reticulocyte curves under a monthly Mircera® treatment were different from the other ESAs, showing a high reticulocyte peak (av. 80 000 reticulocyte/ml) occurring on Day (D)8-D10 after Mircera® administration. On the contrary, at nadir's point (D20-D30 after injection), reticulocyte levels are low for all the patients, preventing from any interpretation of the reticulocyte level at monthly routine assessment. It looks as though it is the peak level of reticulocytes that should be used as a marker of ESA response.

Therefore, monitoring of reticulocytes would support the therapeutic decision on the need to adapt the EPO dose.

The study is design to determinated the interest of the reticulocyte peak in the daily practice

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

94

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

      • Angers, Frankrig, 49933
        • CHU Angers
      • Brest, Frankrig, 29200
        • CHRU La Cavale Blanche
      • Brest, Frankrig, 29200
        • AUB Brest
      • Lorient, Frankrig
        • CH Bretagne Sud
      • Poitiers, Frankrig, 86021
        • CHRU de POITIERS
      • Quimper, Frankrig
        • Ch Cornouaille
      • Rennes, Frankrig
        • CHU Pontchaillou
      • Saint Brieuc, Frankrig
        • CH Yves Le Foll
      • Saint Malo, Frankrig
        • CH Broussais

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

Beskrivelse

Inclusion Criteria:

  • Age> or equal to 18 years
  • Patients on hemodialysis or hemodiafiltration for at least 3 months
  • Patient treated monthly by Mircera® for at least one month
  • Affiliate or enjoying a social security scheme
  • Patients who received oral and written information about the study, with no objection to the use of personal data and having signed an informed consent form and written

Exclusion Criteria:

  • Patient who refused to give his written consent to the study
  • Patients treated with another Erythropoiesis stimulating agent
  • Minor
  • Pregnant or breastfeeding women
  • Major under guardianship

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Reticera
A blood sample (before dialysis) under the usual conditions will be performed at D0 (= the day of Mircera® injection) and 9 days (+/- 1 day) after each injection Mircera® for hemoglobin and reticulocytes dosage for a period of 6 months.
A blood sample (before dialysis) under the usual conditions will be performed at D0 (= the day of Mircera® injection) 9 days (+/- 1 day) after each injection Mircera® for hemoglobin and reticulocytes dosage for a period of 6 months.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reticulocyte peak
Tidsramme: Day 9
variation of the reticulocyte peak compared with hemoglobin level
Day 9

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean reticulocyte peak
Tidsramme: 6 months
Reticulocyte peak is collected at D9 after monthly Mircera injection, patient are followed 6 months. The mean of th reticulocyte peak will be calculated at 6 months
6 months

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Yannick LE MEUR, PUPH, Brest Hospital

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)

22. juni 2016

Primær færdiggørelse (Faktiske)

20. juni 2021

Studieafslutning (Faktiske)

30. juni 2021

Datoer for studieregistrering

Først indsendt

23. juni 2016

Først indsendt, der opfyldte QC-kriterier

13. juli 2016

Først opslået (Skøn)

14. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • RETICERA

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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