Study Stopped
inclusion difficulties
Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera Hemodialysis Population
RETICERA
1 other identifier
interventional
94
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 22, 2016
CompletedFirst Submitted
Initial submission to the registry
June 23, 2016
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedMarch 4, 2022
March 1, 2022
5 years
June 23, 2016
March 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reticulocyte peak
variation of the reticulocyte peak compared with hemoglobin level
Day 9
Secondary Outcomes (1)
Mean reticulocyte peak
6 months
Study Arms (1)
Reticera
OTHERA 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
CHU Angers
Angers, 49933, France
AUB Brest
Brest, 29200, France
CHRU La Cavale Blanche
Brest, 29200, France
CH Bretagne Sud
Lorient, France
CHRU de Poitiers
Poitiers, 86021, France
CH Cornouaille
Quimper, France
CHU Pontchaillou
Rennes, France
CH Yves LE FOLL
Saint-Brieuc, France
Ch Broussais
St-Malo, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yannick LE MEUR, PUPH
Brest Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2016
First Posted
July 14, 2016
Study Start
June 22, 2016
Primary Completion
June 20, 2021
Study Completion
June 30, 2021
Last Updated
March 4, 2022
Record last verified: 2022-03