Steroid avoidance with early intensified dosing of enteric-coated mycophenolate sodium: a randomized multicentre trial in kidney transplant recipients.
BACKGROUND
Short-term intensified dosing using enteric-coated mycophenolate sodium (EC-MPS) reduces rejection after kidney transplantation without compromising safety and may facilitate steroid avoidance.


METHODS
In a 6-month, multicentre open-label trial, 222 de novo kidney transplant recipients at low-immunological risk were randomized to steroid avoidance or maintenance steroids with interleukin (IL)-2 receptor antibody (IL-2RA) induction, EC-MPS (2160 mg/day to Week 6, 1440 mg/day thereafter) and cyclosporine.


RESULTS
The primary end point; treatment failure at Month 6 [biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up], occurred in 17.9% (20/112) of steroid-avoidance patients and 14.5% (16/110) of controls (difference 3.4%, 95% confidence interval -6.3 to 13.1, P = 0.47 for superiority testing). BPAR occurred in 11.6 and 7.3% of patients in the steroid-avoidance and control arms, respectively (P = 0.27). Creatinine clearance was similar at Month 6 (steroid-avoidance 56 ± 18 mL/min/1.73 m(2), controls 60 ± 22 mL/min/1.73 m(2), P = 0.34). Cytomegalovirus infection, as reported by investigators, occurred in 12.5% of steroid-avoidance patients and 22.7% of controls (P = 0.045).


CONCLUSIONS
A regimen of early intensified EC-MPS dosing with calcineurin inhibitor and IL-2RA induction permits oral steroid avoidance in adult kidney transplant patients at low-immunological risk without compromising efficacy at 6 months' follow-up.
Service de Néphrologie et Transplantation Rénale, Hôpital La Milétrie, Poitiers, France.
Antoine
A
Thierry
Georges
G
Mourad
Matthias
M
Büchler
Nassim
N
Kamar
Florence
F
Villemain
Anne-Elisabeth
AE
Heng
Yannick
Y
Le Meur
Gabriel
G
Choukroun
Olivier
O
Toupance
Christophe
C
Legendre
Patrick
P
Lepogamp
Michele
M
Kessler
Pierre
P
Merville
Bruno
B
Moulin
Stéphane
S
Quéré
Arara
A
Terpereau
Kamel
K
Chaouche-Teyara
Guy
G
Touchard
D000293:Adolescent; D000305:Adrenal Cortex Hormones; D000328:Adult; D000368:Aged; D016572:Cyclosporine / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011379:Prognosis; D051436:Renal Insufficiency, Chronic / Q000628:therapy*; D013608:Tablets, Enteric-Coated / Q000627:therapeutic use*; D028761:Withholding Treatment; D055815:Young Adult
D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D016572:Cyclosporine; D009173:Mycophenolic Acid