Impact of Clinical Trial Enrollment on Renal Transplant Outcomes
T. Shertel, A. Eisenhart
Saint Barnabas Medical Center, Livingston, NJ
Meeting: 2019 American Transplant Congress
Abstract number: C123
Keywords: Kidney, Monitoring, Outcome, Psychosocial
Session Information
Session Name: Poster Session C: Kidney Psychosocial
Session Type: Poster Session
Date: Monday, June 3, 2019
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Hall C & D
*Purpose: The advancement of science and medicine begins with new therapies and techniques arriving through clinical trials. The possibility of improved patient outcomes may also rest in the strict enrollment in a clinical trial. There is a perceived benefit of enrollment in clinical trials due to closer monitoring by healthcare professionals, additional laboratory tests, adherence to treatment guidelines, and increased patient responsibility in their own outcomes. Studies have been conducted evaluating the benefits of clinical trial enrollment for cancer patients, but there is no data available reviewing this benefit in transplant patients.
*Methods: This retrospective chart review includes data from patients transplanted at Saint Barnabas Medical Center from 1/1/2010 to 6/1/2015. IRB approval was granted through St. Barnabas Medical Center and Rutgers University. The long term outcomes of adult kidney transplant recipients in clinical drug trials were compared to this center’s population outcomes. Patients were included if they were ≥ 18 years of age at the time of transplant and consented to enrollment in a clinical drug trial conducted at this institution. Patients who did not receive a maintenance immunosuppression regimen of a calcineurin inhibitor, antiproliferative agent, and steroids were excluded. Patients were also excluded if they received a novel medication being evaluated to prevent rejection or if they died during their transplant admission. The primary end points were 1 year outcomes of graft and patient survival. The secondary endpoints evaluated were the rate of acute rejection and documentation of non-compliance.
*Results: Data was analyzed using the Fischer’s Exact test through VassarStats. In the study, 5 of the 288 patients in the control arm died at 12 months and no patients died in the intervention arm (p=0.7642). Furthermore, 7 of the 288 patients in the control arm had graft failure at 12 months while there was 1 out of 50 patients in the intervention arm (p=0.7518) with graft failure at 12 months. For acute rejection, the control population had 17 out of 288, with 1 of the 50 in the intervention arm (p= 0.4274). Non-compliance was seen in 19% of patients in the control arm versus 16% in the intervention arm. For delayed graft function (DGF), there was a statistically significant difference between both arms, 111 of the 288 patients in the control arm experienced DGF while only 7 of the 44 in the intervention arm did (p<0.05).
*Conclusions: Clinical trials may prove to offer more benefits than just bringing potential new drugs to market. There was a statistically significant difference in the rate of delayed graft function, however, this diagnosis is not likely attributed to study enrollment. Data was trending in a positive direction in the intervention arm for improved death rates, acute rejection, and graft failure. Further studies with a larger study population would be needed to evaluate these endpoints and to evaluate data extending beyond 12 months post-transplant.
To cite this abstract in AMA style:
Shertel T, Eisenhart A. Impact of Clinical Trial Enrollment on Renal Transplant Outcomes [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/impact-of-clinical-trial-enrollment-on-renal-transplant-outcomes/. Accessed November 22, 2024.« Back to 2019 American Transplant Congress