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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00815867
Other study ID # PI07-PR-CHOUKROUN
Secondary ID 2007/14 CPP2007-
Status Completed
Phase Phase 3
First received December 30, 2008
Last updated April 27, 2016
Start date October 2007
Est. completion date September 2009

Study information

Verified date April 2016
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority FRANCE :Human subjects Protection Committee CPPFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date September 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
epoetin beta (NeoRecormon ®)
comparison of administration of high dosage of epoetin vs no administration of epoetin 30000 UI: 4 injections

Locations

Country Name City State
France Amiens hospital Amiens
France LA CAVALE BLANCHE Hospital Brest
France MONDOR Hospital Creteil
France MICHALLON Hospital Grenoble
France Kremlin Bicêtre Hospital Le Kremlin Bicêtre
France ALBERT CALMETTE Hospital Lille
France CHU Nantes, Hotel-Dieu Hospital Nantes
France CHU Nice, Pasteur Hospital Nice
France Georges Pompidou European Hospital Paris
France Necker Hospital Paris
France TENON Hospital Paris
France LA MILETRIE Hospital Poitiers
France MAISON BLANCHE Hospital Reims
France Bois Guillaume Hospital Rouen
France FOCH Hospital Suresnes
France RANGUEIL Hospital Toulouse
France BRETONNEAU Hospital Tours

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant 30 days No
Secondary The evolution of renal function 90 days No
Secondary The survival of patients and grafts 90 days No
Secondary The time of onset and incidence of acute rejection proved by biopsy 90 days No
Secondary The correction of anemia 90 days No
Secondary The need for transfusions 90 days No
Secondary The need for EPO 90 days No
Secondary Quality of Life 90 days No
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