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Three-Year Outcomes in Kidney Transplant Patients Randomized to Steroid-Free Immunosuppression or Steroid Withdrawal, with Enteric-Coated Mycophenolate Sodium and Cyclosporine: The Infinity Study
Joint Authors
Kessler, M.
Kamar, Nassim
Thierry, A.
Büchler, M.
Choukroun, G.
Toupance, O.
Villemain, F.
Heng, A.-E.
Moulin, B.
Queré, S.
Di Giambattista, F.
Lecuyer, A.
Touchard, G.
Legendre, Christophe
Mourad, Georges
Merville, Pierre
Le Meur, Yannick
Source
Issue
Vol. 2014, Issue 2014 (31 Dec. 2014), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2014-03-04
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
In a six-month, multicenter, open-label trial, de novo kidney transplant recipients at low immunological risk were randomized to steroid avoidance or steroid withdrawal with IL-2 receptor antibody (IL-2RA) induction, enteric-coated mycophenolate sodium (EC-MPS: 2160 mg/day to week 6, 1440 mg/day thereafter), and cyclosporine.
Results from a 30-month observational follow-up study are presented.
Of 166 patients who completed the core study on treatment, 131 entered the follow-up study (70 steroid avoidance, 61 steroid withdrawal).
The primary efficacy endpoint of treatment failure (clinical biopsy-proven acute rejection (BPAR) graft loss, death, or loss to follow-up) occurred in 21.4% (95% CI 11.8–31.0%) of steroid avoidance patients and 16.4% (95% CI 7.1–25.7%) of steroid withdrawal patients by month 36 ( P = 0.46 ).
BPAR had occurred in 20.0% and 11.5%, respectively ( P = 0.19 ).
The incidence of adverse events with a suspected relation to steroids during months 6–36 was 22.9% versus 37.1% ( P = 0.062 ).
By month 36, 32.4% and 51.7% of patients in the steroid avoidance and steroid withdrawal groups, respectively, were receiving oral steroids.
In conclusion, IL-2RA induction with early intensified EC-MPS dosing and CNI therapy in de novo kidney transplant patients at low immunological risk may achieve similar three-year efficacy regardless of whether oral steroids are withheld for at least three months.
American Psychological Association (APA)
Thierry, A.& Mourad, Georges& Büchler, M.& Choukroun, G.& Toupance, O.& Kamar, Nassim…[et al.]. 2014. Three-Year Outcomes in Kidney Transplant Patients Randomized to Steroid-Free Immunosuppression or Steroid Withdrawal, with Enteric-Coated Mycophenolate Sodium and Cyclosporine: The Infinity Study. Journal of Transplantation،Vol. 2014, no. 2014, pp.1-8.
https://search.emarefa.net/detail/BIM-1043280
Modern Language Association (MLA)
Thierry, A.…[et al.]. Three-Year Outcomes in Kidney Transplant Patients Randomized to Steroid-Free Immunosuppression or Steroid Withdrawal, with Enteric-Coated Mycophenolate Sodium and Cyclosporine: The Infinity Study. Journal of Transplantation No. 2014 (2014), pp.1-8.
https://search.emarefa.net/detail/BIM-1043280
American Medical Association (AMA)
Thierry, A.& Mourad, Georges& Büchler, M.& Choukroun, G.& Toupance, O.& Kamar, Nassim…[et al.]. Three-Year Outcomes in Kidney Transplant Patients Randomized to Steroid-Free Immunosuppression or Steroid Withdrawal, with Enteric-Coated Mycophenolate Sodium and Cyclosporine: The Infinity Study. Journal of Transplantation. 2014. Vol. 2014, no. 2014, pp.1-8.
https://search.emarefa.net/detail/BIM-1043280
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1043280