- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
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
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
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
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 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
Sponsor
Efterforskere
- Ledende efterforsker: Yannick LE MEUR, PUPH, Brest Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
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 .
Kliniske forsøg med Nyreinsufficiens, kronisk
-
Jules Bordet InstituteMacopharma; Belgian Hematological SocietyRekrutteringRefractory Chronic Graft Versus Host Disease (cGVHD)Belgien
-
Universitaire Ziekenhuizen KU LeuvenAfsluttetForekomst af Augmented Renal Clearance | Risikofaktorer for øget renal clearanceBelgien
-
The First People's Hospital of ChangzhouIkke rekrutterer endnu
-
Medical University of ViennaAfsluttetGlomerulær filtreringshastighed | Fedtsyrer, ikke-esterificerede | Renal Cirkulation | Renal Plasma FlowØstrig
-
Andrew B AdamsBristol-Myers SquibbAfsluttet
-
Hospices Civils de LyonAfsluttetSkadelig virkning | Renal toksicitetFrankrig
-
University Health Network, TorontoAfsluttetGlomerulær filtreringshastighed | Renal blodgennemstrømningCanada
-
National Cancer Institute (NCI)AfsluttetLunge | Bryst | Ovarie | Cervikal | RenalForenede Stater
-
Oregon Health and Science UniversityAfsluttet- Undersøgelsesfokus: Renal retention af lipidmikroboblerForenede Stater