Prospective, randomized, multi-center trial of antibody induction therapy in simultaneous pancreas-kidney transplantation

Dixon B. Kaufman; George W. Burke; David S. Bruce; Christopher P. Johnson; A. Osama Gaber; David E.R. Sutherland; Robert M. Merion; Scott A. Gruber; Eugene Schweitzer; John P. Leone; Christopher L. Marsh; Edward Alfrey; Waldo Concepcion; Mark D. Stegall; James A. Schulak; Paul F. Gores; Enrico Benedetti; Craig Smith; Alice K. Henning; Fernando Kuehnel; Sarah King; William E. Fitzsimmons

doi:10.1034/j.1600-6143.2003.00160.x

Prospective, randomized, multi-center trial of antibody induction therapy in simultaneous pancreas-kidney transplantation

Dixon B. Kaufman, George W. Burke, David S. Bruce, Christopher P. Johnson, A. Osama Gaber, David E.R. Sutherland, Robert M. Merion, Scott A. Gruber, Eugene Schweitzer, John P. Leone, Christopher L. Marsh, Edward Alfrey, Waldo Concepcion, Mark D. Stegall, James A. Schulak, Paul F. Gores, Enrico Benedetti, Craig Smith, Alice K. Henning, Fernando KuehnelSarah King, William E. Fitzsimmons

Transplant Surgery

Research output: Contribution to journal › Article › peer-review

47 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	855-864
Number of pages	10
Journal	American Journal of Transplantation
Volume	3
Issue number	7
DOIs	https://doi.org/10.1034/j.1600-6143.2003.00160.x
State	Published - Jul 2003

Keywords

Immunosuppression
Induction therapy
Pancreas transplantation

ASJC Scopus subject areas

Immunology and Allergy
Transplantation
Pharmacology (medical)

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10.1034/j.1600-6143.2003.00160.x

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Kaufman, D. B., Burke, G. W., Bruce, D. S., Johnson, C. P., Gaber, A. O., Sutherland, D. E. R., Merion, R. M., Gruber, S. A., Schweitzer, E., Leone, J. P., Marsh, C. L., Alfrey, E., Concepcion, W., Stegall, M. D., Schulak, J. A., Gores, P. F., Benedetti, E., Smith, C., Henning, A. K., ... Fitzsimmons, W. E. (2003). Prospective, randomized, multi-center trial of antibody induction therapy in simultaneous pancreas-kidney transplantation. American Journal of Transplantation, 3(7), 855-864. https://doi.org/10.1034/j.1600-6143.2003.00160.x

Kaufman, DB, Burke, GW, Bruce, DS, Johnson, CP, Gaber, AO, Sutherland, DER, Merion, RM, Gruber, SA, Schweitzer, E, Leone, JP, Marsh, CL, Alfrey, E, Concepcion, W, Stegall, MD, Schulak, JA, Gores, PF, Benedetti, E, Smith, C, Henning, AK, Kuehnel, F, King, S & Fitzsimmons, WE 2003, 'Prospective, randomized, multi-center trial of antibody induction therapy in simultaneous pancreas-kidney transplantation', American Journal of Transplantation, vol. 3, no. 7, pp. 855-864. https://doi.org/10.1034/j.1600-6143.2003.00160.x

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title = "Prospective, randomized, multi-center trial of antibody induction therapy in simultaneous pancreas-kidney transplantation",

abstract = "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.",

keywords = "Immunosuppression, Induction therapy, Pancreas transplantation",

author = "Kaufman, {Dixon B.} and Burke, {George W.} and Bruce, {David S.} and Johnson, {Christopher P.} and Gaber, {A. Osama} and Sutherland, {David E.R.} and Merion, {Robert M.} and Gruber, {Scott A.} and Eugene Schweitzer and Leone, {John P.} and Marsh, {Christopher L.} and Edward Alfrey and Waldo Concepcion and Stegall, {Mark D.} and Schulak, {James A.} and Gores, {Paul F.} and Enrico Benedetti and Craig Smith and Henning, {Alice K.} and Fernando Kuehnel and Sarah King and Fitzsimmons, {William E.}",

year = "2003",

month = jul,

doi = "10.1034/j.1600-6143.2003.00160.x",

language = "English (US)",

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T1 - Prospective, randomized, multi-center trial of antibody induction therapy in simultaneous pancreas-kidney transplantation

AU - Kaufman, Dixon B.

AU - Burke, George W.

AU - Bruce, David S.

AU - Johnson, Christopher P.

AU - Gaber, A. Osama

AU - Sutherland, David E.R.

AU - Merion, Robert M.

AU - Gruber, Scott A.

AU - Schweitzer, Eugene

AU - Leone, John P.

AU - Marsh, Christopher L.

AU - Alfrey, Edward

AU - Concepcion, Waldo

AU - Stegall, Mark D.

AU - Schulak, James A.

AU - Gores, Paul F.

AU - Benedetti, Enrico

AU - Smith, Craig

AU - Henning, Alice K.

AU - Kuehnel, Fernando

AU - King, Sarah

AU - Fitzsimmons, William E.

PY - 2003/7

Y1 - 2003/7

N2 - 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.

AB - 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.

KW - Immunosuppression

KW - Induction therapy

KW - Pancreas transplantation

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JO - American Journal of Transplantation

JF - American Journal of Transplantation

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ER -

Prospective, randomized, multi-center trial of antibody induction therapy in simultaneous pancreas-kidney transplantation

Abstract

Keywords

ASJC Scopus subject areas

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