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

Sponsor
University Hospital, Brest (Other)
Overall Status
Terminated
CT.gov ID
NCT02832323
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Reticera
N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
94 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera
Actual Study Start Date :
Jun 22, 2016
Actual Primary Completion Date :
Jun 20, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Biological: Reticera
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.

Outcome Measures

Primary Outcome Measures

  1. Reticulocyte peak [Day 9]

    variation of the reticulocyte peak compared with hemoglobin level

Secondary Outcome Measures

  1. Mean reticulocyte peak [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Angers Angers France 49933
2 AUB Brest Brest France 29200
3 CHRU La Cavale Blanche Brest France 29200
4 CH Bretagne Sud Lorient France
5 CHRU de Poitiers Poitiers France 86021
6 CH Cornouaille Quimper France
7 CHU Pontchaillou Rennes France
8 CH Yves LE FOLL Saint Brieuc France
9 Ch Broussais Saint Malo France

Sponsors and Collaborators

  • University Hospital, Brest

Investigators

  • Principal Investigator: Yannick LE MEUR, PUPH, Brest Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT02832323
Other Study ID Numbers:
  • RETICERA
First Posted:
Jul 14, 2016
Last Update Posted:
Mar 4, 2022
Last Verified:
Mar 1, 2022
Keywords provided by University Hospital, Brest
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 4, 2022