Prospective, Randomized, Multi‐Center Trial of Antibody Induction Therapy in Simultaneous Pancreas‐Kidney Transplantation
Year: 2003
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Authors: Dixon B. Kaufman, George W. Burke III, 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
Institutions: Northwestern University, University of Miami, University of Chicago, Medical College of Wisconsin, University of Tennessee Health Science Center, University of Minnesota, University of Michigan, The University of Texas Health Science Center at Houston, University of Maryland, Baltimore, University of Nebraska at Omaha, University of Washington, Stanford University, Loma Linda University, Loma Linda University Health Care, Mayo Clinic, University Hospitals of Cleveland, Case Western Reserve University, Carolinas Medical Center, University of Illinois Chicago, University of California, Los Angeles, Emmes (United States)
Language: English
Subfield: Transplantation
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,300
OpenAlex ID: W2121551057