Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera Hemodialysis Population (RETICERA)
Primary Purpose
Renal Insufficiency, Chronic
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Reticera
Sponsored by
About this trial
This is an interventional other trial for Renal Insufficiency, Chronic focused on measuring hemodialysis, EPO, MIRCERA
Eligibility Criteria
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
Sites / Locations
- CHU Angers
- AUB Brest
- CHRU La Cavale Blanche
- CH Bretagne Sud
- CHRU de Poitiers
- CH Cornouaille
- CHU Pontchaillou
- CH Yves LE FOLL
- Ch Broussais
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Reticera
Arm Description
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.
Outcomes
Primary Outcome Measures
Reticulocyte peak
variation of the reticulocyte peak compared with hemoglobin level
Secondary Outcome Measures
Mean reticulocyte peak
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
Full Information
NCT ID
NCT02832323
First Posted
June 23, 2016
Last Updated
March 3, 2022
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT02832323
Brief Title
Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera Hemodialysis Population
Acronym
RETICERA
Official Title
Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
inclusion difficulties
Study Start Date
June 22, 2016 (Actual)
Primary Completion Date
June 20, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
Keywords
hemodialysis, EPO, MIRCERA
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reticera
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Reticera
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reticulocyte peak
Description
variation of the reticulocyte peak compared with hemoglobin level
Time Frame
Day 9
Secondary Outcome Measure Information:
Title
Mean reticulocyte peak
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yannick LE MEUR, PUPH
Organizational Affiliation
Brest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
AUB Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHRU La Cavale Blanche
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CH Bretagne Sud
City
Lorient
Country
France
Facility Name
CHRU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CH Cornouaille
City
Quimper
Country
France
Facility Name
CHU Pontchaillou
City
Rennes
Country
France
Facility Name
CH Yves LE FOLL
City
Saint Brieuc
Country
France
Facility Name
Ch Broussais
City
Saint Malo
Country
France
12. IPD Sharing Statement
Learn more about this trial
Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera Hemodialysis Population
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