Renal Insufficiency, ChronicRETICERANCT02832323
Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera Hemodialysis Population
A study testing Reticera in people with Renal Insufficiency, Chronic, run by University Hospital, Brest at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Reticera
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 9 sitesFrance
- Study dates
- 22 Jun 2016to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU Angers
Angers, 49933
AUB Brest
Brest, 29200
CHRU La Cavale Blanche
Brest, 29200
CH Bretagne Sud
Lorient
CHRU de Poitiers
Poitiers, 86021
CH Cornouaille
Quimper
CHU Pontchaillou
Rennes
CH Yves LE FOLL
Saint-Brieuc
Ch Broussais
St-Malo
About this study
Official title: 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.
Read the 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
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Reticera
- Keywords
- hemodialysis, EPO, MIRCERA
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReticeraBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Reticera | Other | 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. Receives: Biological: Reticera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reticulocyte peak
variation of the reticulocyte peak compared with hemoglobin level
Measured: Day 9
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start22 Jun 2016
- Primary completion20 Jun 2021
- Study completion30 Jun 2021
Why it stopped: inclusion difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yannick LE MEUR, PUPH, Principal investigator, Brest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832323
- Sponsor's protocol ID
- RETICERA
- Acronym
- RETICERA
- Status last verified
- Mar 2022
- First submitted
- 23 Jun 2016
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera
- ClinicalTrials.gov ID
- NCT02832323
- Acronym / sponsor ID
- RETICERA / RETICERA
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- hemodialysis, EPO, MIRCERA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion difficulties
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 22 Jun 2016 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reticera | Other | Biological: ReticeraA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReticeraA 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. | Biological | Reticera |
Primary outcome
Reticulocyte peak
Time frame: Day 9
variation of the reticulocyte peak compared with hemoglobin level
1 secondary outcome
Mean reticulocyte peak
Time frame: 6 months
Results and safety
The study was stopped early (reason given: inclusion difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannick LE MEUR, PUPH principal investigator
Brest Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reticera in people with Renal Insufficiency, Chronic, run by University Hospital, Brest at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inclusion difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reticulocyte peak (time frame: Day 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.