Living Donor Kidney Transplant Recipients and Clinical Trials: Participation Profiles and Impact on Post-Transplant Care

Authors: Brennan, T. V.¹; Fuller, T. F.²; Vincenti, F.¹; Chan, S.¹; Chang, C. K.¹; Bostrom, A.³; Zlatunich, J. K.¹; Tomlanovich, S. J.¹; Feng, S.

Source: American Journal of Transplantation, Volume 6, Number 10, October 2006 , pp. 2429-2435(7)

Publisher: Wiley-Blackwell

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Abstract:

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.

Keywords: Clinical trial; kidney transplant; living donor; outcomes

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1600-6143.2006.01504.x

Affiliations: 1: Department of Surgery, Division of Transplantation 2: Department of Urology, Charite University Hospital, Berlin, Germany 3: Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, California, USA

Publication date: 2006-10-01

Living Donor Kidney Transplant Recipients and Clinical Trials: Participation Profiles and Impact on Post-Transplant Care

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