High dose epoetin beta in the first weeks following renal transplantation and delayed graft function: Results of the Neo-PDGF Study.
Erythropoietin promotes nephroprotection in animal models of ischemia-reperfusion injury. Neorecormon and Prevention of Delayed Graft Function (Neo-PDGF) is a French open-label multicenter randomized study to evaluate the effect of high doses of epoetin beta (EPO-beta) during the first 2 weeks of renal transplantation on renal function in patients at risk for delayed graft function (DGF). One hundred and four patients were included in the study. Patients randomized in treatment group (A) received four injections of EPO-beta (30.000 UI each), given before surgery and at 12 h, 7 days and 14 days posttransplantation. Patients randomized in control group (B) did not receive EPO-beta. Immunosuppression included induction with basiliximab and maintenance therapy with steroids, mycophenolate mofetil and tacrolimus. At 1 month posttransplant, the estimated glomerular filtration rate (MDRD formula) was 42.5 +/- 19.0 mL/min in the EPO-beta group and 44.0 +/- 16.3 mL/min in the control group (p = ns). The frequency of DGF was similar in both groups (32% vs. 38.8%; p = ns). No difference in the incidence of serious adverse events was observed. (ClinicalTrials.gov number, NCT00815867.).
Martinez
F
F
Hôpital Necker, Assistance Publique Hôpitaux de Paris et Université Paris Descartes, France. frank.martinez@nck.aphp.fr
Kamar
N
N
Pallet
N
N
Lang
P
P
Durrbach
A
A
Lebranchu
Y
Y
Adem
A
A
Barbier
S
S
Cassuto-Viguier
E
E
Glowaki
F
F
Le Meur
Y
Y
Rostaing
L
L
Legendre
C
C
Hermine
O
O
Choukroun
G
G
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000077552:Basiliximab; D001794:Blood Pressure; D015992:Body Mass Index; D003404:Creatinine / Q000097:blood; D051799:Delayed Graft Function / Q000188:drug therapy*; D004921:Erythropoietin / Q000627:therapeutic use*; D005260:Female; D005602:France; D005919:Glomerular Filtration Rate / Q000187:drug effects*; D006084:Graft Rejection / Q000453:epidemiology; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000009:adverse effects* / Q000276:immunology / Q000502:physiology; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D010982:Platelet-Derived Growth Factor / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D011994:Recombinant Proteins; D006435:Renal Dialysis; D012449:Safety; D016559:Tacrolimus / Q000627:therapeutic use
D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D006454:Hemoglobins; D007166:Immunosuppressive Agents; D010982:Platelet-Derived Growth Factor; D011993:Recombinant Fusion Proteins; D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin; D000077552:Basiliximab; D003404:Creatinine; D009173:Mycophenolic Acid; D016559:Tacrolimus