Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant (Neo-PDGF)

Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.

Study Overview

• Status: Completed
• Conditions: Kidney Failure
• Intervention / Treatment: Drug: epoetin beta (NeoRecormon ®)

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • Amiens Hospital
  • Brest, France, 29200
    • La Cavale Blanche Hospital
  • Creteil, France, 94010
    • MONDOR Hospital
  • Grenoble, France, 38000
    • MICHALLON Hospital
  • Le Kremlin Bicêtre, France, 94275
    • Kremlin Bicetre hospital
  • Lille, France, 59 000
    • ALBERT CALMETTE Hospital
  • Nantes, France, 44093
    • CHU Nantes, Hotel-Dieu Hospital
  • Nice, France, 06000
    • CHU Nice, Pasteur Hospital
  • Paris, France, 75020
    • Tenon Hospital
  • Paris, France, 75015
    • Georges Pompidou European Hospital
  • Paris, France, 75
    • Necker Hospital
  • Poitiers, France, 86000
    • LA MILETRIE Hospital
  • Reims, France, 51100
    • MAISON BLANCHE Hospital
  • Rouen, France, 76230
    • Bois Guillaume Hospital
  • Suresnes, France, 92151
    • Foch Hospital
  • Toulouse, France, 31000
    • Rangueil hospital
  • Tours, France, 37044
    • Bretonneau Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: B
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 Names: Neorecormon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
The need for EPO	90 days
Quality of Life	90 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Roche Pharma AG
• Investigators: Principal Investigator: CHOUKROUN Gabriel, Ph D, CHU Amiens; Principal Investigator: MARTINEZ Franck, Ph D, Necker Hospital

Publications and helpful links

General Publications

• Martinez 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: December 30, 2008
• First Submitted That Met QC Criteria: December 30, 2008
• First Posted (Estimate): December 31, 2008

Study Record Updates

• Last Update Posted (Estimate): April 28, 2016
• Last Update Submitted That Met QC Criteria: April 27, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: kidney transplant; graft function; kidney failure; epoetin; haemoglobin
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Hematinics; Epoetin Alfa
• Other Study ID Numbers: PI07-PR-CHOUKROUN; 2007/14 CPP; 2007-002562-35 EudraCT