RS-61443 (mycophenolate mofetil). A multicenter study for refractory kidney transplant rejection.
RS-61443 (mycophenolate mofetil) inhibits a key enzyme of the de novo synthesis of purine nucleotides in T and B lymphocytes. The purpose of this study was to evaluate the efficacy of RS-61443 in patients with refractory renal allograft rejection. Patients eligible for the study had previously undergone anti-rejection therapy with high-dose steroids or OKT3 monoclonal antibody. All rejection episodes were proven by renal biopsy. Successful rescue was achieved in 52 (69%) patients. Rescue was more successful when patients were entered with a creatinine of 4 mg/dL or lower (79%), versus a 52% rescue rate in patients entered with a creatinine of 4 mg/dL or above. Major side effects were predominantly gastrointestinal, but there was no overt nephrotoxicity, hepatotoxicity, or bone marrow suppression. The overall infection rate was 40%, with the spectrum of infections characteristic for the highly immunocompromised patient. The conclude that this pilot study suggests that RS-61443 is effective in refractory kidney allograft rejection. Based on this study, prospectively randomized multi-center trails have been planned and are in progress.
Sollinger
H W
HW
University of Wisconsin Hospital, Department of Surgery, Madison 53792.
Belzer
F O
FO
Deierhoi
M H
MH
Diethelm
A G
AG
Gonwa
T A
TA
Kauffman
R S
RS
Klintmalm
G B
GB
McDiarmid
S V
SV
Roberts
J
J
Rosenthal
J T
JT
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D003404:Creatinine / Q000097:blood; D005260:Female; D006084:Graft Rejection; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007668:Kidney / Q000473:pathology; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010865:Pilot Projects
D007166:Immunosuppressive Agents; D003404:Creatinine; D009173:Mycophenolic Acid