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.
Astelleas Pharma Global Develepment, Northbrook, IL.
Meeting: 2016 American Transplant Congress
Abstract number: D309
Keywords: African-American, Immunosuppression, Kidney transplantation, Meta-analysis
Session Information
Session Name: Poster Session D: Late Breaking
Session Type: Poster Session
Date: Tuesday, June 14, 2016
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 (n= 721) |
Black ER-T (n = 87) |
Caucasian ER-T (n=1227) |
p-value |
| Pre-op DM (%) | 26.0 | 13.5 | 12.6 | 13.8 | 0.286 |
| HgbA1c (%) | 5.79 | 5.40 | 5.58 | 5.38 | 0.009 |
| 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 |
| Avg. PRA | 3.3 | 1.8 | 3.6 | 1.8 | 0.124 |
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 May 20, 2025.« Back to 2016 American Transplant Congress