Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Halls C&D
INTRO: When contemplating the use of a new immunosuppressant agent in kidney transplantation, measuring outcomes in potentially vulnerable populations is of paramount concern. As such, we report the first large-scale clinical efficacy data of extended-release tacrolimus (ER-T) in Black (Bl) kidney transplant recipients (KTRs), a group historically underrepresented in clinical trials and with generally inferior outcomes when compared to other ethnic groups.
METHODS: Results were pooled from three, large Phase III RCTs as part of an ER-T (Astagraf XL) clinical development program (n=2162). Logistic regression and proportionate hazards were used to ascertain differences between treatment groups over 24 weeks.
RESULTS: Despite a higher degree of HLA-mismatch (P<0.001) in Bl de novo KTRs treated with ER-T, clinical efficacy was statistically non-inferior to Caucasians (Caucs) treated with ER-T or immediate-release tacrolimus (IR-T, Prograf®). Likewise, in Blacks treated with ER-T, therapeutic equivalence was observed vs. IR-T and eGFR was noted to be similar.
|Parameter|| Black IR-T|
(n = 77)
| Caucasian IR-T|
| Black ER-T|
(n = 87)
| Caucasian ER-T|
|Pre-op DM (%)||26.0||13.5||12.6||13.8||0.286|
|Pre-op HTN (%)||89.6||86.8||95.4||87.1||0.827|
|Living Donor (%)||26.0||25.8||17.2||19.0||<0.001|
|Avg. HLA mismatch||4.1||3.1||3.8||3.1||<0.001|
CONCLUSIONS: While higher rates of acute rejection and graft loss have typically been observed in Bl KTRs, Blacks treated with ER-T demonstrated results comparable to that of Caucs in this pooled analysis of Phase III data.
CITATION INFORMATION: Schwartz J, Wilson S, Shi F, Undre N, Kumar M. Therapeutically Equivalent Results to Caucasians in Black Kidney Transplant Recipients Using ASTAGRAF XL® Despite a Higher Degree of HLA Mismatch : A Post-Hoc Analysis of Phase III Data from Over 2000 Patients. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:Schwartz J, Wilson S, Shi F, Undre N, Kumar M. Therapeutically Equivalent Results to Caucasians in Black Kidney Transplant Recipients Using ASTAGRAF XL® Despite a Higher Degree of HLA Mismatch : A Post-Hoc Analysis of Phase III Data from Over 2000 Patients. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/therapeutically-equivalent-results-to-caucasians-in-black-kidney-transplant-recipients-using-astagraf-xl-despite-a-higher-degree-of-hla-mismatch-a-post-hoc-analysis-of-phase-iii-data-from-over/. Accessed February 19, 2020.
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