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

This study is currently recruiting participants.
Verified October 2017 by University Hospital, Brest
Sponsor:
ClinicalTrials.gov Identifier:
NCT02832323
First Posted: July 14, 2016
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Brest
  Purpose
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 Intervention
Renal Insufficiency, Chronic Biological: Reticera

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Reticulocyte peak [ Time Frame: Day 9 ]
    variation of the reticulocyte peak compared with hemoglobin level


Secondary Outcome Measures:
  • Mean reticulocyte peak [ Time Frame: 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


Estimated Enrollment: 150
Actual Study Start Date: June 22, 2016
Estimated Study Completion Date: December 22, 2019
Estimated Primary Completion Date: December 22, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832323


Contacts
Contact: Yannick LE MEUR, PUPH yannick.lemeur@chu-brest.fr

Locations
France
Centre de Néphrologie et de dialyse d'Armorique Withdrawn
Brest, France, 29200
CHRU La Cavale Blanche Recruiting
Brest, France, 29200
Contact: Yannick LE MEUR, PUPH         
CH Bretagne Sud Recruiting
Lorient, France
Contact: Mathilde LEJEUNE, PH         
CHU Hôtel Dieu Not yet recruiting
Nantes, France
Contact: Caroline Gourraud-Vercel, PH         
ECHO Nantes Monfort Withdrawn
Nantes, France
CH Cornouaille Recruiting
Quimper, France
Contact: Pascale SIOHAN, PH         
CHU Pontchaillou Not yet recruiting
Rennes, France
Contact: Atman Haddj ELMRABET, PH         
CH Yves LE FOLL Not yet recruiting
Saint Brieuc, France
Contact: Christophe CHARASSE, PH         
Ch Broussais Not yet recruiting
Saint Malo, France
Contact: Eric RENAUDINEAU, PH         
CH Cité Sanitaire Georges Charpak Not yet recruiting
Saint Nazaire, France
Contact: Sandrine DURAULT, PH         
ECHO Withdrawn
Vannes, France, PH
CH Bretagne Atlantique Not yet recruiting
Vannes, France
Contact: Lise MANDART, PH         
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Yannick LE MEUR, PUPH Brest Hospital
  More Information

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02832323     History of Changes
Other Study ID Numbers: RETICERA
First Submitted: June 23, 2016
First Posted: July 14, 2016
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by University Hospital, Brest:
hemodialysis
EPO
MIRCERA

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases