- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02832323
Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera Hemodialysis Population (RETICERA)
Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera
Studieoversikt
Detaljert 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
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Angers, Frankrike, 49933
- CHU Angers
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Brest, Frankrike, 29200
- CHRU La Cavale Blanche
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Brest, Frankrike, 29200
- AUB Brest
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Lorient, Frankrike
- Ch Bretagne Sud
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Poitiers, Frankrike, 86021
- CHRU de POITIERS
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Quimper, Frankrike
- Ch Cornouaille
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Rennes, Frankrike
- CHU Pontchaillou
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Saint Brieuc, Frankrike
- CH Yves Le Foll
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Saint Malo, Frankrike
- CH Broussais
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Reticulocyte peak
Tidsramme: Day 9
|
variation of the reticulocyte peak compared with hemoglobin level
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Day 9
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Yannick LE MEUR, PUPH, brest Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RETICERA
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