Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
Neo-PDGF
3 other identifiers
interventional
108
1 country
17
Brief Summary
Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2007
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 30, 2008
CompletedFirst Posted
Study publicly available on registry
December 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedApril 28, 2016
April 1, 2016
1.5 years
December 30, 2008
April 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant
30 days
Secondary Outcomes (7)
The evolution of renal function
90 days
The survival of patients and grafts
90 days
The time of onset and incidence of acute rejection proved by biopsy
90 days
The correction of anemia
90 days
The need for transfusions
90 days
- +2 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALPatient will receive Epoetin Beta
B
NO INTERVENTIONInterventions
comparison of administration of high dosage of epoetin vs no administration of epoetin 30000 UI: 4 injections
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire, Amienslead
- Roche Pharma AGcollaborator
Study Sites (17)
Amiens hospital
Amiens, 80000, France
LA CAVALE BLANCHE Hospital
Brest, 29200, France
MONDOR Hospital
Créteil, 94010, France
MICHALLON Hospital
Grenoble, 38000, France
Kremlin Bicêtre Hospital
Le Kremlin-Bicêtre, 94275, France
ALBERT CALMETTE Hospital
Lille, 59 000, France
CHU Nantes, Hotel-Dieu Hospital
Nantes, 44093, France
CHU Nice, Pasteur Hospital
Nice, 06000, France
Georges Pompidou European Hospital
Paris, 75015, France
TENON Hospital
Paris, 75020, France
Necker Hospital
Paris, 75, France
LA MILETRIE Hospital
Poitiers, 86000, France
MAISON BLANCHE Hospital
Reims, 51100, France
Bois Guillaume Hospital
Rouen, 76230, France
FOCH Hospital
Suresnes, 92151, France
RANGUEIL Hospital
Toulouse, 31000, France
BRETONNEAU Hospital
Tours, 37044, France
Related Publications (2)
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.
PMID: 36791280DERIVEDMartinez 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.
PMID: 20642691DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CHOUKROUN Gabriel, Ph D
CHU Amiens
- PRINCIPAL INVESTIGATOR
MARTINEZ Franck, Ph D
Necker Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2008
First Posted
December 31, 2008
Study Start
October 1, 2007
Primary Completion
April 1, 2009
Study Completion
September 1, 2009
Last Updated
April 28, 2016
Record last verified: 2016-04