Kidney FailurePhase 3Neo-PDGFNCT00815867
Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
A Phase 3 study testing epoetin beta (NeoRecormon ®) in people with Kidney Failure, run by Centre Hospitalier Universitaire, Amiens at 17 sites in France.
Trial summary
Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Failure
- What is being tested?
- epoetin beta (NeoRecormon ®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 17 sitesFrance
- Study dates
- Oct 2007to Sep 2009
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males anf Females aged between 18 and 75
- Patients having given their written consent
- Patient determined to participate in the test and to respect the requirements
- Patient covered by a social insurance
- Patient to be kidney transplanted (from a cadaveric donor)
- Patient benefiting from the 1st or 2nd kidney transplant
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- Patient formerly treated by peritoneal dialysis or hemodialysis
- Patient receiving a graft with risk of delayed graft function (score> 7 combining age of the donor, ischemia time, receiver ethnicity and cause of death)
- Patient to receive treatment with basiliximab, mycophenolate mofetil, tacrolimus and corticosteroid
Who cannot join
- Patient Pregnant or nursing
- Patient with a disability that does not ensure the good understanding of the study and its imperatives , or patient having dependency (alcohol, drugs)
- Patient receiving doses of epoetin beta or alpha> 30,000 IU / week or darbepoetin> 150 microg / week before transplanting
- Patient who has participated in a clinical trial in the last month or currently included in another test
- Patient in safeguarding justice, guardianship or trusteeship
- Patient receiving a third transplant or hyper immune or who have a positive historic cross-match
Show all 18Show fewer
- Patient receiving a preemptive transplant
- graft from a living donor
- graft with 3 or more arteries
- Multi-Organ Transplantation
- Patient with heart failure stage> III
- Patients with unstable ischemic heart disease, or have had a major coronary event less than 6 months, stroke or TIA <6 months or symptomatic arteritis of lower limbs stage ≥ 3
- Patients with active viral infection: hepatitis B, C (PCR + only) or HIV
- Patient with a history of anemia from erythroblastopenia
- Patient receiving anticoagulant treatment(AVK) before renal transplantation and to be continued after transplant
- Patient with a preoperative rate Hb> 14 g / dL (before ultrafiltration)
- A patient with known hypersensitivity to the active substance or to any of the excipients, or to benzoic acid
- Patients with poorly controlled hypertension in the weeks before transplantation (Diastolic Blood Pressure ≥ 110 mm Hg with more than 3 antihypertensive drugs)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Amiens hospital
Amiens, 80000
LA CAVALE BLANCHE Hospital
Brest, 29200
MONDOR Hospital
Créteil, 94010
MICHALLON Hospital
Grenoble, 38000
Kremlin Bicêtre Hospital
Le Kremlin-Bicêtre, 94275
ALBERT CALMETTE Hospital
Lille, 59 000
CHU Nantes, Hotel-Dieu Hospital
Nantes, 44093
CHU Nice, Pasteur Hospital
Nice, 06000
Georges Pompidou European Hospital
Paris, 75015
TENON Hospital
Paris, 75020
Necker Hospital
Paris, 75
LA MILETRIE Hospital
Poitiers, 86000
MAISON BLANCHE Hospital
Reims, 51100
Bois Guillaume Hospital
Rouen, 76230
FOCH Hospital
Suresnes, 92151
RANGUEIL Hospital
Toulouse, 31000
BRETONNEAU Hospital
Tours, 37044
About this study
Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.
Read the detailed description
French study, prospective, multicenter, open, randomized into two parallel groups:
Group A: NeoRecormon ® 30000 UI: 4 injections Group B: control group without administration of the medical product
Period of recruitment: 18 months Duration of participation of each patient: 90 days Total duration of the test: 21 months.
Main objective : Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant.
Secondary objectives:
Comparing the 2 groups at all times J0 to J90:
- The evolution of renal function
- The survival of patients and grafts
- The time of onset and incidence of acute rejection proved by biopsy
- The correction of anemia
- The need for transfusions
- The need for EPO
- Quality of Life
- The safety processing
- Conditions
- Kidney Failure
- Being tested
- epoetin beta (NeoRecormon ®)
- Keywords
- kidney failure, kidney transplant, graft function, haemoglobin, epoetin
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin beta (NeoRecormon ®)Drug
Also called Neorecormon
comparison of administration of high dosage of epoetin vs no administration of epoetin
30000 UI: 4 injections
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Patient will receive Epoetin Beta Receives: Drug: epoetin beta (NeoRecormon ®) |
| B | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant
Measured: 30 days
Secondary outcomes (7)
The evolution of renal function
Measured: 90 days
The survival of patients and grafts
Measured: 90 days
The time of onset and incidence of acute rejection proved by biopsy
Measured: 90 days
The correction of anemia
Measured: 90 days
The need for transfusions
Measured: 90 days
The need for EPO
Measured: 90 days
Quality of Life
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startOct 2007
- Primary completionApr 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- CHOUKROUN Gabriel, Ph D, Principal investigator, CHU AmiensMARTINEZ Franck, Ph D, Principal investigator, Necker Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815867
- Sponsor's protocol ID
- PI07-PR-CHOUKROUN
- Other IDs
- 2007/14 CPP, 2007-002562-35 EudraCT
- Acronym
- Neo-PDGF
- Status last verified
- Apr 2016
- First submitted
- 30 Dec 2008
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PubMed 36791280Martinez F, Kamar N, Pallet N, Lang P, Durrbach A, Lebranchu Y, Adem A, Barbier S, Cassuto-Viguier E, Glowaki F, Le Meur Y, Rostaing L, Legendre C, Hermine O, Choukroun G; NeoPDGF Study Investigators. High dose epoetin beta in the first weeks following renal transplantation and delayed graft function: Results of the Neo-PDGF Study. Am J Transplant. 2010 Jul;10(7):1695-700. doi: 10.1111/j.1600-6143.2010.03142.x.
PubMed 20642691
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
- ClinicalTrials.gov ID
- NCT00815867
- Acronym / sponsor ID
- Neo-PDGF / PI07-PR-CHOUKROUN
- Conditions
- Kidney Failure
- Keywords
- kidney failure, kidney transplant, graft function, haemoglobin, epoetin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Oct 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 31 Dec 2008 (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.
Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.
Detailed description
French study, prospective, multicenter, open, randomized into two parallel groups:
Group A: NeoRecormon ® 30000 UI: 4 injections Group B: control group without administration of the medical product
Period of recruitment: 18 months Duration of participation of each patient: 90 days Total duration of the test: 21 months.
Main objective : Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant.
Secondary objectives:
Comparing the 2 groups at all times J0 to J90:
- The evolution of renal function
- The survival of patients and grafts
- The time of onset and incidence of acute rejection proved by biopsy
- The correction of anemia
- The need for transfusions
- The need for EPO
- Quality of Life
- The safety processing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: epoetin beta (NeoRecormon ®)Patient will receive Epoetin Beta |
| B | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males anf Females aged between 18 and 75
- Patients having given their written consent
- Patient determined to participate in the test and to respect the requirements
- Patient covered by a social insurance
- Patient to be kidney transplanted (from a cadaveric donor)
Key exclusion criteria (18 listed)
- Patient Pregnant or nursing
- Patient with a disability that does not ensure the good understanding of the study and its imperatives , or patient having dependency (alcohol, drugs)
- Patient receiving doses of epoetin beta or alpha> 30,000 IU / week or darbepoetin> 150 microg / week before transplanting
- Patient who has participated in a clinical trial in the last month or currently included in another test
- Patient in safeguarding justice, guardianship or trusteeship
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 |
|---|---|---|
| epoetin beta (NeoRecormon ®)Also: Neorecormoncomparison of administration of high dosage of epoetin vs no administration of epoetin 30000 UI: 4 injections | Drug | A |
Primary outcome
Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant
Time frame: 30 days
7 secondary outcomes
The evolution of renal function
Time frame: 90 days
The survival of patients and grafts
Time frame: 90 days
The time of onset and incidence of acute rejection proved by biopsy
Time frame: 90 days
The correction of anemia
Time frame: 90 days
The need for transfusions
Time frame: 90 days
The need for EPO
Time frame: 90 days
Quality of Life
Time frame: 90 days
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 28 Apr 2016.
- Derived from this study: PubMed 36791280Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
- Derived from this study: PubMed 20642691Martinez F, Kamar N, Pallet N, Lang P, Durrbach A, Lebranchu Y, Adem A, Barbier S, Cassuto-Viguier E, Glowaki F, Le Meur Y, Rostaing L, Legendre C, Hermine O, Choukroun G; NeoPDGF Study Investigators. High dose epoetin beta in the first weeks following renal transplantation and delayed graft function: Results of the Neo-PDGF Study. Am J Transplant. 2010 Jul;10(7):1695-700. doi: 10.1111/j.1600-6143.2010.03142.x.
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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.
CHOUKROUN Gabriel, Ph D principal investigator
CHU Amiens
MARTINEZ Franck, Ph D principal investigator
Necker Hospital
17 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 epoetin beta (NeoRecormon ®) in people with Kidney Failure, run by Centre Hospitalier Universitaire, Amiens at 17 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 18 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 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 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?
Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00815867, which also lists 2 linked publications.
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 28 Apr 2016.