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

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.

Study Overview

• Status: Terminated
• Conditions: Renal Insufficiency, Chronic
• Intervention / Treatment: Biological: Reticera

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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Chu Angers
  • Brest, France, 29200
    • CHRU La Cavale Blanche
  • Brest, France, 29200
    • AUB Brest
  • Lorient, France
    • CH Bretagne Sud
  • Poitiers, France, 86021
    • CHRU de POITIERS
  • Quimper, France
    • Ch Cornouaille
  • Rennes, France
    • CHU Pontchaillou
  • Saint Brieuc, France
    • CH Yves Le Foll
  • Saint Malo, France
    • CH Broussais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reticulocyte peak	variation of the reticulocyte peak compared with hemoglobin level	Day 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Yannick LE MEUR, PUPH, Brest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2016
• Primary Completion (Actual): June 20, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: hemodialysis; EPO; MIRCERA
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: RETICERA