NCT00815867CompletedPhase 3
Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
Centre Hospitalier Universitaire, Amiens17 sites in 1 country108 target enrollmentStarted: October 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 108
- Locations
- 17
- Primary Endpoint
- Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant
Study Overview
Brief Summary
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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)
Arms & Interventions
A
Experimental
Patient will receive Epoetin Beta
Intervention: epoetin beta (NeoRecormon ®) (Drug)
Outcomes
Primary Outcomes
Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant
Time Frame: 30 days
Secondary Outcomes
- The need for transfusions(90 days)
- The need for EPO(90 days)
- Quality of Life(90 days)
- 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)
Investigators
Study Sites (17)
Loading locations...
Similar Trials
Active, not recruiting
Not Applicable
ffet de l’Epoetin Beta sur la fonction rénale et l’anémie dans les trente jours suivant une transplantation rénale - Etude Neo-PDGFPatients insuffisants rénaux chroniques, au stade terminal de leur affection, traités en dialyse. Patients, hommes ou femmes, agés de 18 à 75 ans, devant bénéficier d'une transplantation rénale à partir d'un donneur en coma dépassé et étant à risque de récupération lente de la fonction du greffon. Randomisés pour recevoir 4 injections de 30000 UI de NeoRecormon (Epoetin bêta) avant le déclampage, 12 heures après la greffe et à J7 et J14 (Groupe A), ou aucun traitement (Groupe B).MedDRA version: 9.1Level: LLTClassification code 10058116Term: Nephrogenic anaemiaMedDRA version: 9.1Level: LLTClassification code 10009120Term: Chronic renal failure anaemiaEUCTR2007-002562-35-FRCHU AMIENS
Completed
Not Applicable
Effect of epoetin beta pegol treatment on renal anemia and blood pressure control in non-dialytic CKD patientsnon-dyalitic chronic kidney disease (CKD)JPRN-UMIN000009449Kurashiki Central Hospital100
Completed
Not Applicable
Erythropoeitin effect on Chronic Kidney DiseaseChronic Kidney Disease.Kidney damage with mild decreased GFR (60-89 mL/min)IRCT2016043027686N1Zahedan University of Medical Sciences60
Not yet recruiting
Not Applicable
The influence of administration of epoetin beta pegol (CERA) and saccharated ferric oxide on erythroferron and hepcidin of hemodialyzed patientsHemodialyzed patients with renal anemiaJPRN-UMIN000016552Hyogo College of Medicine50
Completed
Phase 4
A prospective comparison of epoetin beta pegol and darbepoetin alpha in the variability of blood pressure in pre-dialysis chronic kidney disease (CKD).Chronic kidney disease anemiaJPRN-UMIN000008505Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine36