Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant (Neo-PDGF)
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Purpose
Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Failure |
Drug: epoetin beta (NeoRecormon ®) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant |
- Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- The evolution of renal function [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- The survival of patients and grafts [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- The time of onset and incidence of acute rejection proved by biopsy [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- The correction of anemia [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- The need for transfusions [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- The need for EPO [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: 90 days ] [ Designated as safety issue: No ]
| Enrollment: | 108 |
| Study Start Date: | October 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Patient will receive Epoetin Beta
|
Drug: epoetin beta (NeoRecormon ®)
comparison of administration of high dosage of epoetin vs no administration of epoetin 30000 UI: 4 injections Other Name: Neorecormon
|
| No Intervention: B |
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
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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)
Contacts and Locations| France | |
| Amiens hospital | |
| Amiens, France, 80000 | |
| LA CAVALE BLANCHE Hospital | |
| Brest, France, 29200 | |
| MONDOR Hospital | |
| Creteil, France, 94010 | |
| MICHALLON Hospital | |
| Grenoble, France, 38000 | |
| Kremlin Bicêtre Hospital | |
| Le Kremlin Bicêtre, France, 94275 | |
| ALBERT CALMETTE Hospital | |
| Lille, France, 59 000 | |
| CHU Nantes, Hotel-Dieu Hospital | |
| Nantes, France, 44093 | |
| CHU Nice, Pasteur Hospital | |
| Nice, France, 06000 | |
| TENON Hospital | |
| Paris, France, 75020 | |
| Necker Hospital | |
| Paris, France, 75 | |
| Georges Pompidou European Hospital | |
| Paris, France, 75015 | |
| LA MILETRIE Hospital | |
| Poitiers, France, 86000 | |
| MAISON BLANCHE Hospital | |
| Reims, France, 51100 | |
| Bois Guillaume Hospital | |
| Rouen, France, 76230 | |
| FOCH Hospital | |
| Suresnes, France, 92151 | |
| RANGUEIL Hospital | |
| Toulouse, France, 31000 | |
| BRETONNEAU Hospital | |
| Tours, France, 37044 | |
| Principal Investigator: | CHOUKROUN Gabriel, Ph D | CHU Amiens |
| Principal Investigator: | MARTINEZ Franck, Ph D | Necker Hospital |
More Information
No publications provided by Centre Hospitalier Universitaire, Amiens
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Centre Hospitalier Universitaire, Amiens |
| ClinicalTrials.gov Identifier: | NCT00815867 History of Changes |
| Other Study ID Numbers: | PI07-Pr CHOUKROUN, 2007/14 CPP, 2007-002562-35 EudraCT |
| Study First Received: | December 30, 2008 |
| Last Updated: | October 19, 2011 |
| Health Authority: | FRANCE :Human subjects Protection Committee CPP France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Hospitalier Universitaire, Amiens:
|
kidney failure kidney transplant graft function haemoglobin epoetin |
Additional relevant MeSH terms:
|
Renal Insufficiency Kidney Diseases Urologic Diseases Epoetin Alfa |
Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013