IschemiaPhase 3FRETEPNCT01450878
Renal Graft Function After Treatment With Erythropoietin (EPO)
A Phase 3 study testing beta-epoietin in people with Ischemia, run by University Hospital, Limoges at 18 sites in France.
Trial summary
Background : Numerous studies have outlined the cellular pleiotropic effects of erythropoietin (EPO) and their role in the prevention of ischemic-reperfusion lesion such as after acute ischemic injury of the brain or the heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia
- What is being tested?
- beta-epoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 18 sitesFrance
- Study dates
- Dec 2011to Mar 2013
- Phase
- Phase 3
- 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
- donor:
- cadaveric organ donor,
- age ≥ 18 years,
- mono-organ (kidney) retrieval,
- retrieval done in the centres of Limoges, Bordeaux, Toulouse, Angers, Brest, Nantes, Poitiers, Rennes, Tours,
- hematocrit ≤ 45%.
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- Recipient:
- age ≥ 18 years,
- on the waiting list for a kidney graft.
Who cannot join
- living donors,
- age under 18 years,
- multi-organ retrieval,
- donor hematocrit above 45%
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Néphrologie
Angers, 49000
CHU d'ANGERS - CHPOT
Angers, 49933
CHU de BORDEAUX - CHPOT
Bordeaux, 33076
CHU de BORDEAUX - Service de Néphrologie
Bordeaux, 33076
Néphrologie
Brest, 29 609
CHU de BREST - CHPOT
Brest, 29609
CHU de LIMOGES - CHPOT
Limoges, 87042
CHU de LIMOGES - Service de Néphrologie
Limoges, 87042
CHU de NANTES - CHPOT
Nantes, 44093
CHU de NANTES - Service de Néphrologie
Nantes, 44093
Néphrologie
Poitiers, 86000
CHU de POITIERS - CHPOT
Poitiers, 86021
CHU de RENNES - CHPOT
Rennes, 35033
CHU de RENNES - Service de Néphrologie
Rennes, 35033
CHU de TOULOUSE - CHPOT
Toulouse, 31059
CHU de TOULOUSE - Service de Néphrologie
Toulouse, 31059
Néphrologie
Tours, 37000
CHU de TOURS - CHPOT
Tours, 37044
About this study
Official title: Interest of a High Dose of Erythropoietin Administered During Graft Processing for Early Graft Outcome in Kidney Transplant Recipients.
Background : Numerous studies have outlined the cellular pleiotropic effects of erythropoietin (EPO) and their role in the prevention of ischemic-reperfusion lesion such as after acute ischemic injury of the brain or the heart. However, most of these studies were carried out in animal models and no definitive proof exists today to demonstrate that EPO has similar beneficial effects in human pathology.
Purpose : The aim of the study is to demonstrate that in humans, EPO can protect against ischemic-reperfusion lesions in a model of ischemia i.e. kidney transplantation.
Read the detailed description
Abstract : Since the discovery that EPO and its receptor are expressed in various tissues, numerous studies have demonstrated that EPO is not only involved in erythropoiesis but also exerts pleiotropic effects on cells. Among these, one of the most exciting is its role in the prevention of ischemic-reperfusion lesions such as after acute ischemic injury of the brain or the heart. However, most of these studies were carried out in animal models and no definitive proof exists today to demonstrate that EPO has similar beneficial effects in human pathology. Kidney transplantation is one ischemic situation where EPO pleiotropic effects could be of great interest since ischemic-reperfusion lesions have been involved in delayed graft function and impaired graft outcomes.
The aim of this prospective randomized double blind study is to assess the effect of 100 000 UI of béta-epoiétin on kidney graft function, given to the deceased donor one hour before the retreaval of the organ. Recipients will be followed for three months in order to evaluate kidney function (glomerular filtration rate) and the number of acute rejection episodes to determine whether beta-epoietin could modify the immunogenicity of the graft.
- Conditions
- Ischemia
- Being tested
- beta-epoietin
- Keywords
- high dose of EPO, transplant kidney, cadaveric organ donor, mono-organ (kidney) retrieval, patient, kidney graft
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beta-epoietinDrug
100 000UI beta-epoietin injection one hour before organ retrieval
| Study group | Role | What they receive |
|---|---|---|
| Graft with EPO | Experimental | intravenous 1000 000UI beta-epoietin one hour before organe retrieval. Receives: Drug: beta-epoietin |
| graft without EPO | No intervention | no injection befoe organ retrieval |
What is being measured
The primary outcome is the main question the study is designed to answer.
a plasma creatinin level
To assess the effect of an injection of 100 000 UI of beta-epoitein during graft processing, on the proportion of renal recipients with a plasma creatinin level below 250 µM at day 5 after transplantation in the absence of hemodialysis, death or transplantectomy.
Measured: 5 days
Secondary outcomes (3)
The incidence of delayed graft function defined as follows:
The incidence of delayed graft function defined as follows: combination of the need for dialysis (except dialysis for hyperkalemia or volume overload) or creatinine reduction ratio of less than 25% within the first 48 h post-transplant.
Measured: 48 hours
MDRD glomerular filtration rate at one and three months
MDRD glomerular filtration rate at one and three months
Measured: three months
The incidence of acute rejection during the first three months
The incidence of acute rejection during the first three months
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Lack of patients eligible for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Marie ESSIG, MD, Principal investigator, CHU LIMOGES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450878
- Sponsor's protocol ID
- I09002 FRETEP
- Acronym
- FRETEP
- Status last verified
- Sep 2016
- First submitted
- 10 Oct 2011
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of a High Dose of Erythropoietin Administered During Graft Processing for Early Graft Outcome in Kidney Transplant Recipients.
- ClinicalTrials.gov ID
- NCT01450878
- Acronym / sponsor ID
- FRETEP / I09002 FRETEP
- Conditions
- Ischemia
- Keywords
- high dose of EPO, transplant kidney, cadaveric organ donor, mono-organ (kidney) retrieval, patient, kidney graft
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients eligible for the study.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Oct 2011 (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.
Background : Numerous studies have outlined the cellular pleiotropic effects of erythropoietin (EPO) and their role in the prevention of ischemic-reperfusion lesion such as after acute ischemic injury of the brain or the heart. However, most of these studies were carried out in animal models and no definitive proof exists today to demonstrate that EPO has similar beneficial effects in human pathology.
Purpose : The aim of the study is to demonstrate that in humans, EPO can protect against ischemic-reperfusion lesions in a model of ischemia i.e. kidney transplantation.
Detailed description
Abstract : Since the discovery that EPO and its receptor are expressed in various tissues, numerous studies have demonstrated that EPO is not only involved in erythropoiesis but also exerts pleiotropic effects on cells. Among these, one of the most exciting is its role in the prevention of ischemic-reperfusion lesions such as after acute ischemic injury of the brain or the heart. However, most of these studies were carried out in animal models and no definitive proof exists today to demonstrate that EPO has similar beneficial effects in human pathology. Kidney transplantation is one ischemic situation where EPO pleiotropic effects could be of great interest since ischemic-reperfusion lesions have been involved in delayed graft function and impaired graft outcomes.
The aim of this prospective randomized double blind study is to assess the effect of 100 000 UI of béta-epoiétin on kidney graft function, given to the deceased donor one hour before the retreaval of the organ. Recipients will be followed for three months in order to evaluate kidney function (glomerular filtration rate) and the number of acute rejection episodes to determine whether beta-epoietin could modify the immunogenicity of the graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graft with EPO | Experimental | Drug: beta-epoietinintravenous 1000 000UI beta-epoietin one hour before organe retrieval. |
| graft without EPO | No intervention | –no injection befoe organ retrieval |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- donor:
- Recipient:
Key exclusion criteria (4 listed)
- living donors,
- age under 18 years,
- multi-organ retrieval,
- donor hematocrit above 45%
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 |
|---|---|---|
| beta-epoietin100 000UI beta-epoietin injection one hour before organ retrieval | Drug | Graft with EPO |
Primary outcome
a plasma creatinin level
Time frame: 5 days
To assess the effect of an injection of 100 000 UI of beta-epoitein during graft processing, on the proportion of renal recipients with a plasma creatinin level below 250 µM at day 5 after transplantation in the absence of hemodialysis, death or transplantectomy.
3 secondary outcomes
The incidence of delayed graft function defined as follows:
Time frame: 48 hours
MDRD glomerular filtration rate at one and three months
Time frame: three months
The incidence of acute rejection during the first three months
Time frame: three months
Results and safety
The study was stopped early (reason given: Lack of patients eligible for the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
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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.
Marie ESSIG, MD principal investigator
CHU LIMOGES
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing beta-epoietin in people with Ischemia, run by University Hospital, Limoges at 18 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 9 inclusion and 4 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 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of patients eligible for the study.). 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?
a plasma creatinin level (time frame: 5 days). 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 5 Sep 2016.