Background: The OPTN Pancreas Transplantation Committee is attempting to define pancreas graft failure and performed a study to determine if C-peptide corresponds to pancreas graft failure as reported to the OPTN.

Methods: C-peptide data from 7 participating centers (n=415 graft failures for transplants from 2002-2012) were collected and analyzed after IRB approval. C-peptide values pre-transplant as well as at center-determined graft failure and return to insulin were analyzed for trends between time points.

Results: A total of 233 C-peptide values were submitted at graft failure, 149 values submitted for pre-transplant, and 94 at return to insulin. There were 77 transplants with values at both pre-transplant and graft failure. For recipients in the study who had C-peptide <1 ng/ml pre-transplant and had a post-transplant C-peptide value (n=61), graft failure was declared at varying levels of C-peptide. High C-peptide values at graft failure were not explained by stimulated testing (6% stimulated, 89% fasting, 5% unknown), or by single-center bias. Of the 36 recipients with values at all 3 points, 30 returned to insulin at graft failure.

Conclusions: Centers declare graft failure at varying levels of C-peptide and do not consistently collect C-peptide on patients. Either C-peptide is not used for evaluating graft function, or other factors influence reporting of graft failure. These data do not support use of C-peptide as a criteria for the definition of pancreas graft failure. Obtaining a better understanding of the etiology of pancreas graft failures nationally is hindered by limited objective data collected on OPTN forms and by center-declared graft status.

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