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Kidney Week

Abstract: TH-PO1113

Graft Function and Other Outcomes in Kidney Transplant Recipients Converting from Immediate-Release to Prolonged-Release Tacrolimus

Session Information

  • Late-Breaking Posters
    November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Transplantation

  • 2102 Transplantation: Clinical

Authors

  • Krämer, Bernhard K., University Hospital, Mannheim, Germany
  • Kamar, Nassim, Toulouse University, Toulouse, France
  • Kóbori, László, Semmelweis University, Budapest, Hungary
  • Lemoine, Mathilde, Hopital Charles Nicolle, Rouen, France
  • Nemes, Balazs, University of Debrecen, Debrecen, Hungary
  • Lee, Su Hyung, Ajou University School of Medicine, Suwon, Gyeonggi-do, Korea (the Republic of)
  • Ha, Hai An Phan, Viet Duc University Hospital, Hanoi, Viet Nam
  • Watarai, Yoshihiko, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan
  • Yang, Jaeseok, Yonsei University College of Medicine, Seoul, Korea (the Republic of)
  • Han, Seungyeup, Keimyung University School of Medicine, Daegu, Korea (the Republic of)
  • Kuypers, Dirk R., University Hospitals Leuven, Leuven, Belgium
  • Blogg, Martin, Astellas Pharma Europe, Ltd., Addlestone, United Kingdom
  • Harkavyi, Alexander, Astellas Pharma Europe, Ltd., Addlestone, United Kingdom
  • Repetur, Carola, Astellas Pharma Europe, Ltd., Addlestone, United Kingdom
  • Scrine, Ludmila, Astellas Pharma Europe, Ltd., Addlestone, United Kingdom
  • Soliman, Mohamed, Astellas Pharma Singapore Pte Ltd., Singapore, Singapore
Background

CHORUS (NCT02555787) was a long-term, prospective, global, non-interventional study investigating clinical outcomes in kidney transplant recipients (KTRs) converted from twice-daily, immediate-release tacrolimus to once-daily, prolonged-release tacrolimus (PRT; Advagraf®, Astellas Pharma Europe, Ltd.) under standard practice conditions.

Methods

This study enrolled KTRs (≥18 years, N=4389) who converted to PRT based on the judgment of their treating physician. Based on the post-transplant time of conversion, KTRs were grouped into early converters (ECs; ≤6 months) or late converters (LCs; >6 months). The primary endpoint was the change in renal function (measured by estimated glomerular filtration rate, eGFR) from conversion up to 5 years; secondary endpoints included graft survival (GS). GS was also assessed using subgroup variables: converters after <3 vs ≥3 years of transplant; no changes vs changes in immunosuppressive (IS) regimen (other than PRT); coefficient of variation (CV) for tacrolimus levels <35% vs ≥35%

Results

The full analysis set included 4028 KTRs (ECs, 1060; LCs, 2968). Mean eGFR at conversion was 56.1 mL/min/1.73m2; it remained stable post-conversion in the overall and LCs, with improvements in the ECs over 5 years. Kaplan-Meier estimate of 5-year GS was 95.0% (ECs, 88.1%; LCs, 97.3%). GS was higher in KTRs with no changes vs KTRs with changes in IS regimen. GS was similar in KTRs in <35% and ≥35% tacrolimus CV subgroups. GS was higher in converters after ≥3 years vs <3 years of transplant. GS was higher in LCs vs ECs across all subgroups (Table).

Conclusion

Results from this large cohort of KTRs showed overall stable renal function. Graft survival was high 5 years post-transplant, supporting the long-term use of PRT. In addition, some KTR subgroups (IS regimen changes, ECs with ≥35% CV, converters after <3 years) may benefit from closer monitoring.