Renal Insufficiency, ChronicSELFEPONCT03481686
Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections
A study testing Patients with injections of ESA in people with Renal Insufficiency, Chronic and Organ Graft, run by Rennes University Hospital at 1 site in France.
Trial summary
In chronic kidney disease, ESAs (Erythropoiesis-stimulating agents) are used to treat anemia. This anemia is due to decreased renal production of erythropoietin (EPO), a hormone that stimulates the production of red blood cells in the bone marrow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic, Organ Graft
- What is being tested?
- Patients with injections of ESA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2018to 9 Feb 2022
- 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
- Patients monitored for chronic renal failure, or for renal transplantation regardless of clearance level;
- Patients whose disease requires regular injections of ESA (before hospitalization or since hospitalization);
- Patients who did not realize their injection themselves before hospitalization;
- Patients hospitalized in the nephrology department at Rennes university hospital ;
- Obtaining free, informed and written consent;
- Affiliation to social security.
Who cannot join
- Major incapable persons and persons deprived of their liberty;
- Dialysis patients or for whom dialysis is envisaged within 3 months;
- Pregnant or nursing mothers;
- Patients who are already performing their ASE injections alone;
- Simultaneous participation in another research protocol involving the human person.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SelfEPO - Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections
In chronic kidney disease, ESAs (Erythropoiesis-stimulating agents) are used to treat anemia. This anemia is due to decreased renal production of erythropoietin (EPO), a hormone that stimulates the production of red blood cells in the bone marrow. Treatment of anemia increases survival, decreases morbidity and improves quality of life and exercise tolerance.
Self-administration of ASE has been encouraged for many years, notably with pens for injection, but only few patients are educated in the injection technique.
The investigators therefore wish to lead a study in the Nephrology department of Rennes University Hospital to educate the patient, or his or her spouse, on ESA injections during hospitalization, in order to empower the patient in his care, and with the second aim of reducing the costs of chronic renal insufficiency.
Read the detailed description
Erythropoiesis-stimulating agents (ESAs) are numerous and prescribed, depending on the molecule, once a week to once a month. They have improved the management of pre-dialysis patients, increased their hemoglobin and decreased transfusion needs, improving their morbidity and mortality and quality of life.
They are administered in pre-dialysis or post-renal transplantation most often by subcutaneous injection, which can be done by the patient himself, a member of his family or a nurse. Self-administration of ASE has been encouraged for many years, notably with pens for injection, but only few pilot studies show the feasibility of these auto-injections of ASE and patient satisfaction.
In 2012, the investigators conducted a practice study whose main objective was to have a picture of ESA injection practices for pre-dialysis patients. It is an observational, epidemiological, prospective and multicentric study, carried out by a questionnaire completed by the nephrologist during a consultation.
At the end of a 6-month collection period, 143 records were collected. All the patients questioned were followed for chronic renal insufficiency, not yet dialysed and not transplanted.
The majority of patients enrolled in this study were in the maintenance phase for ASE prescription (86% versus 14% in the correction phase), the mean age was 66.4 +/- 16.9 years. In 70.2% of cases the injection is done by a nurse, compared to 24.8% of injections made by the patient himself and 4.9% by his spouse. For 86.7%, the injection was done at home, and for 60% without other associated care. The nurse therefore came only for the injection of ASE. Not surprisingly, at an equal ASE cost, the resort to a nurse is significantly more expensive.
- Conditions
- Renal Insufficiency, Chronic, Organ Graft
- Being tested
- Patients with injections of ESA
- Keywords
- Erythropoiesis, stimulating, agents, therapeutic, education, program
- 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.
Patients with injections of ESADevice
Patients will perform ASE injections themselves or by their spouses
| Study group | Role | What they receive |
|---|---|---|
| Patients with injections of ESA | Experimental | Patients with injections of ESA Receives: Device: Patients with injections of ESA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients performing all their injections themselves and / or their spouse
Measured: 6 months
Secondary outcomes (11)
Number of patients performing all their injections themselves
Measured: 1 month
Number of patients performing all their injections themselves
Measured: 3 months
Percentage of injections performed by the nurse vs by themselves and / or their spouse before empowerment
Measured: 6 months
Number of patients who performed all their injections by their spouse
Measured: 6 months
Number of injections performed on the number of prescribed injections
Treatment compliance
Measured: 6 months
Injection site pain
pain assessment with a visual analog scale (0 = no pain, 10 = maximum pain)
Measured: 6 months
Side effects of ESA injection
Measured: 6 months
Number of patients stopping self-injections
Measured: 6 months
Reason for stopping self-injections
evaluation of reason for stopping self-injections with a questionnaire
Measured: 6 months
Number of patients refusing therapeutic education
Measured: 6 months
Reason for refusing therapeutic education
evaluation of reason for refusing therapeutic education with a questionnaire
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 posted29 Mar 2018
- Study start21 Sep 2018
- Primary completion9 Feb 2022
- Study completion9 Feb 2022
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 Rennes University HospitalThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile VIGNEAU, Principal investigator, Rennes University HospitalHugoline BOULAY, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481686
- Sponsor's protocol ID
- 35RC16_9864_SELFEPO
- Other IDs
- 2017-A00295-48
- Acronym
- SELFEPO
- Status last verified
- Jun 2022
- First submitted
- 19 Mar 2018
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SelfEPO - Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections
- ClinicalTrials.gov ID
- NCT03481686
- Acronym / sponsor ID
- SELFEPO / 35RC16_9864_SELFEPO
- Conditions
- Renal Insufficiency, Chronic, Organ Graft
- Keywords
- Erythropoiesis, stimulating, agents, therapeutic, education, program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 29 Mar 2018 (actual)
- 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.
In chronic kidney disease, ESAs (Erythropoiesis-stimulating agents) are used to treat anemia. This anemia is due to decreased renal production of erythropoietin (EPO), a hormone that stimulates the production of red blood cells in the bone marrow. Treatment of anemia increases survival, decreases morbidity and improves quality of life and exercise tolerance.
Self-administration of ASE has been encouraged for many years, notably with pens for injection, but only few patients are educated in the injection technique.
The investigators therefore wish to lead a study in the Nephrology department of Rennes University Hospital to educate the patient, or his or her spouse, on ESA injections during hospitalization, in order to empower the patient in his care, and with the second aim of reducing the costs of chronic renal insufficiency.
Detailed description
Erythropoiesis-stimulating agents (ESAs) are numerous and prescribed, depending on the molecule, once a week to once a month. They have improved the management of pre-dialysis patients, increased their hemoglobin and decreased transfusion needs, improving their morbidity and mortality and quality of life.
They are administered in pre-dialysis or post-renal transplantation most often by subcutaneous injection, which can be done by the patient himself, a member of his family or a nurse. Self-administration of ASE has been encouraged for many years, notably with pens for injection, but only few pilot studies show the feasibility of these auto-injections of ASE and patient satisfaction.
In 2012, the investigators conducted a practice study whose main objective was to have a picture of ESA injection practices for pre-dialysis patients. It is an observational, epidemiological, prospective and multicentric study, carried out by a questionnaire completed by the nephrologist during a consultation.
At the end of a 6-month collection period, 143 records were collected. All the patients questioned were followed for chronic renal insufficiency, not yet dialysed and not transplanted.
The majority of patients enrolled in this study were in the maintenance phase for ASE prescription (86% versus 14% in the correction phase), the mean age was 66.4 +/- 16.9 years. In 70.2% of cases the injection is done by a nurse, compared to 24.8% of injections made by the patient himself and 4.9% by his spouse. For 86.7%, the injection was done at home, and for 60% without other associated care. The nurse therefore came only for the injection of ASE. Not surprisingly, at an equal ASE cost, the resort to a nurse is significantly more expensive.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with injections of ESA | Experimental | Device: Patients with injections of ESAPatients with injections of ESA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients monitored for chronic renal failure, or for renal transplantation regardless of clearance level;
- Patients whose disease requires regular injections of ESA (before hospitalization or since hospitalization);
- Patients who did not realize their injection themselves before hospitalization;
- Patients hospitalized in the nephrology department at Rennes university hospital ;
- Obtaining free, informed and written consent;
Key exclusion criteria (5 listed)
- Major incapable persons and persons deprived of their liberty;
- Dialysis patients or for whom dialysis is envisaged within 3 months;
- Pregnant or nursing mothers;
- Patients who are already performing their ASE injections alone;
- Simultaneous participation in another research protocol involving the human person.
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 |
|---|---|---|
| Patients with injections of ESAPatients will perform ASE injections themselves or by their spouses | Device | Patients with injections of ESA |
Primary outcome
Number of patients performing all their injections themselves and / or their spouse
Time frame: 6 months
11 secondary outcomes
Number of patients performing all their injections themselves
Time frame: 1 month
Number of patients performing all their injections themselves
Time frame: 3 months
Percentage of injections performed by the nurse vs by themselves and / or their spouse before empowerment
Time frame: 6 months
Number of patients who performed all their injections by their spouse
Time frame: 6 months
Number of injections performed on the number of prescribed injections
Time frame: 6 months
Injection site pain
Time frame: 6 months
Side effects of ESA injection
Time frame: 6 months
Number of patients stopping self-injections
Time frame: 6 months
Reason for stopping self-injections
Time frame: 6 months
Number of patients refusing therapeutic education
Time frame: 6 months
Reason for refusing therapeutic education
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 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.
Cécile VIGNEAU principal investigator
Rennes University Hospital
Hugoline BOULAY study chair
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients with injections of ESA in people with Renal Insufficiency, Chronic and Organ Graft, run by Rennes University Hospital at 1 site 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 6 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: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients performing all their injections themselves and / or their spouse (time frame: 6 months). 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 23 Jun 2022.