Prospective, randomized, multi-center trial of antibody induction therapy in simultaneous pancreas-kidney transplantation.
A randomized, multicenter, prospective study was conducted at 18 pancreas transplant centers in the United States to determine the role of induction therapy in simultaneous pancreas-kidney (SPK) transplantation. One hundred and 74 recipients were enrolled: 87 recipients each in the induction and noninduction treatment arms. Maintenance immunosuppression consisted of tacrolimus, mycophenolate mofetil, and corticosteroids. There were no statistically significant differences between treatment groups for patient, kidney, and pancreas graft survival at 1-year. The 1-year cumulative incidence of any treated biopsy-confirmed or presumptive rejection episodes (kidney or pancreas) in the induction and noninduction treatment arms was 24.6% and 31.2% (p = 0.28), respectively. The 1-year cumulative incidence of biopsy-confirmed, treated, acute kidney allograft rejection in the induction and noninduction treatment arms was 13.1% and 23.0% (p = 0.08), respectively. Biopsy-confirmed kidney allograft rejection occurred later post-transplant and appeared to be less severe among recipients that received induction therapy. The highest rate of Cytomegalovirus (CMV) viremia/syndrome was observed in the subgroup of recipients who received T-cell depleting antibody induction and received organs from CMV serologically positive donors. Decisions regarding the routine use of induction therapy in SPK transplantation must take into consideration its differential effects on risk of rejection and infection.
Kaufman
Dixon B
DB
Feinberg School of Medicine at Northwestern University, Chicago, IL, USA. d-kaufman2@northwestern.edu
Burke
George W
GW
Bruce
David S
DS
Johnson
Christopher P
CP
Gaber
A Osama
AO
Sutherland
David E R
DE
Merion
Robert M
RM
Gruber
Scott A
SA
Schweitzer
Eugene
E
Leone
John P
JP
Marsh
Christopher L
CL
Alfrey
Edward
E
Concepcion
Waldo
W
Stegall
Mark D
MD
Schulak
James A
JA
Gores
Paul F
PF
Benedetti
Enrico
E
Smith
Craig
C
Henning
Alice K
AK
Kuehnel
Fernando
F
King
Sarah
S
Fitzsimmons
William E
WE
D000906:Antibodies / Q000494:pharmacology*; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007116:Immunization, Passive / Q000379:methods*; D007166:Immunosuppressive Agents / Q000494:pharmacology*; D016030:Kidney Transplantation; D008214:Lymphocytes / Q000276:immunology; D016035:Pancreas Transplantation
D000906:Antibodies; D007166:Immunosuppressive Agents