Pediatric renal transplantation with mycophenolate mofetil-based immunosuppression without induction: results after three years.
BACKGROUND
Mycophenolate mofetil (MMF)-based immunosuppression has reduced the acute rejection rate in adults and in children in the early posttransplantation period. Three-year posttransplantation results have been reported for adults but not for children thus far. In the present open-labeled study, patients 18 years old and younger were evaluated prospectively for up to 3 years after renal transplantation (RTX).


METHODS
Eighty-six patients receiving MMF in combination with cyclosporine and prednisone without induction were evaluated for patient survival, transplant survival, renal function, arterial blood pressure, adverse events, and opportunistic infections. These patients were compared with a historic control group (n=54) receiving azathioprine (AZA) instead of MMF.


RESULTS
Patient survival after 3 years was 98.8% in the MMF group and 94.4% in the AZA group (NS). Intent-to-treat analysis of graft survival demonstrated superiority for MMF (98% vs. 80%; P<0.001). Cumulative acute rejection episodes occurred in 47% of patients in the MMF group versus 61% in the AZA group (P<0.05). Renal function was not significantly different, neither after 3 years nor in the long-term calculation. Antihypertensive medication was administered to 73% to 84% of patients, similar in both groups. Opportunistic infections were recorded only for MMF. Infection rates were comparable to those reported in adults.


CONCLUSIONS
These results suggest that MMF is safe and beneficial as a longer term maintenance immunosuppressive drug in children and adolescents.
Jungraithmayr
Therese
T
Zentrum für Kinderheilkunde und Jugendmedizin, Freiburg, Germany.
Staskewitz
Astrid
A
Kirste
Günter
G
Böswald
Michael
M
Bulla
Monika
M
Burghard
Rainer
R
Dippell
Jürgen
J
Greiner
Christel
C
Helmchen
Udo
U
Klare
Bernd
B
Klaus
Günter
G
Leichter
Heinz E
HE
Mihatsch
Michael J
MJ
Michalk
Dietrich V
DV
Misselwitz
Joachim
J
Plank
Christian
C
Querfeld
Uwe
U
Weber
Lutz T
LT
Wiesel
Manfred
M
Tönshoff
Burkhard
B
Zimmerhackl
Lothar B
LB
D000208:Acute Disease; D000293:Adolescent; D001379:Azathioprine / Q000008:administration & dosage; D001794:Blood Pressure; D002648:Child; D016572:Cyclosporine / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000188:drug therapy* / Q000401:mortality; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000628:therapy; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007668:Kidney / Q000502:physiology; D016030:Kidney Transplantation; D008297:Male; D009173:Mycophenolic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives; D011446:Prospective Studies; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D016572:Cyclosporine; D009173:Mycophenolic Acid; D001379:Azathioprine