Living donor kidney transplant recipients and clinical trials: participation profiles and impact on post-transplant care.
Many transplant physicians believe that transplant candidates who enroll in clinical trials may have better outcomes than those who do not enroll. We examined a 7-year cohort (1997-2003) of adult primary, non-HLA identical, living donor kidney transplant (LDKT) recipients to determine whether demographic characteristics predisposed to enrollment and whether participation affected posttransplant care intensity and/or allograft function. Overall, 146 of 512 (28.5%) LDKT recipients enrolled in clinical trials. LDKT recipients who were male and those who lived <100 miles from our transplant center were significantly more likely to participate. During the first post-transplant year, study patients (SPs) had more clinic visits (p < 0.0001) and more allograft biopsies (p = 0.024) compared to nonstudy patients (NSPs), but comparable numbers of hospital readmissions and allograft ultrasounds. SPs and NSPs did not differ in 1-year creatinine clearance, delta creatinine or rejection incidence. Overall graft and patient survival were comparable. We conclude that clinical trial participants were disproportionately male, had increased intensity of post-transplant care but comparable outcomes to nonparticipants.
Brennan
T V
TV
Department of Surgery, Division of Transplantation, University of California San Francisco, San Francisco, California, USA.
Fuller
T F
TF
Vincenti
F
F
Chan
S
S
Chang
C K
CK
Bostrom
A
A
Zlatunich
J K
JK
Tomlanovich
S J
SJ
Feng
S
S
D000293:Adolescent; D000328:Adult; D002648:Child; D002986:Clinical Trials as Topic; D005260:Female; D005500:Follow-Up Studies; D006085:Graft Survival; D006801:Humans; D016030:Kidney Transplantation; D019520:Living Donors; D008297:Male; D010349:Patient Compliance / Q000706:statistics & numerical data*; D011182:Postoperative Care / Q000379:methods*; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome