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

Kidney Failure Clinical Trial

— Neo-PDGF  

Official title:

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

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

• Kidney Failure
• Renal Insufficiency

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