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

Primary Purpose

Kidney Failure

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
epoetin beta (NeoRecormon ®)
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure focused on measuring kidney failure, kidney transplant, graft function, haemoglobin, epoetin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Amiens hospital
  • LA CAVALE BLANCHE Hospital
  • MONDOR Hospital
  • MICHALLON Hospital
  • Kremlin Bicêtre Hospital
  • ALBERT CALMETTE Hospital
  • CHU Nantes, Hotel-Dieu Hospital
  • CHU Nice, Pasteur Hospital
  • Georges Pompidou European Hospital
  • TENON Hospital
  • Necker Hospital
  • LA MILETRIE Hospital
  • MAISON BLANCHE Hospital
  • Bois Guillaume Hospital
  • FOCH Hospital
  • RANGUEIL Hospital
  • BRETONNEAU Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A

B

Arm Description

Patient will receive Epoetin Beta

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 30, 2008
Last Updated
April 27, 2016
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT00815867
Brief Title
Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
Acronym
Neo-PDGF
Official Title
Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Roche Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure
Keywords
kidney failure, kidney transplant, graft function, haemoglobin, epoetin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Patient will receive Epoetin Beta
Arm Title
B
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
epoetin beta (NeoRecormon ®)
Other Intervention Name(s)
Neorecormon
Intervention Description
comparison of administration of high dosage of epoetin vs no administration of epoetin 30000 UI: 4 injections
Primary Outcome Measure Information:
Title
Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant
Time Frame
30 days
Secondary Outcome Measure Information:
Title
The evolution of renal function
Time Frame
90 days
Title
The survival of patients and grafts
Time Frame
90 days
Title
The time of onset and incidence of acute rejection proved by biopsy
Time Frame
90 days
Title
The correction of anemia
Time Frame
90 days
Title
The need for transfusions
Time Frame
90 days
Title
The need for EPO
Time Frame
90 days
Title
Quality of Life
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHOUKROUN Gabriel, Ph D
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MARTINEZ Franck, Ph D
Organizational Affiliation
Necker Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amiens hospital
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
LA CAVALE BLANCHE Hospital
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
MONDOR Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
MICHALLON Hospital
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Kremlin Bicêtre Hospital
City
Le Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
ALBERT CALMETTE Hospital
City
Lille
ZIP/Postal Code
59 000
Country
France
Facility Name
CHU Nantes, Hotel-Dieu Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU Nice, Pasteur Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Georges Pompidou European Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
TENON Hospital
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Necker Hospital
City
Paris
ZIP/Postal Code
75
Country
France
Facility Name
LA MILETRIE Hospital
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
MAISON BLANCHE Hospital
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Bois Guillaume Hospital
City
Rouen
ZIP/Postal Code
76230
Country
France
Facility Name
FOCH Hospital
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
RANGUEIL Hospital
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
BRETONNEAU Hospital
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20642691
Citation
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.
Results Reference
derived

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Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant

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