Tacrolimus as secondary intervention vs. cyclosporine continuation in patients at risk for chronic renal allograft failure

Thomas Waid, Edward Alfrey, Laura L Mulloy, Faud S. Shihab, David Conti, Richard Freeman, Angelo M. de Mattos, Stephen C. Jensik, Stanley Jordan, George C. Francos, David Van Buren, Larry Chan, Robert W. Steiner, Giacomo Basadonna, Karl Brinker, Steven Steinberg, Arthur J. Matas, Anne L. King, Bertram L. Kasiske, David J. CohenDavid Surer, Sharon Inokuchi, John D. Pirsch, Jonathan S. Bromberg, Matthew R. Weir, Stuart M. Greenstein, Stephen J. Tomlanovich, Robert Mendez, Lawrence Kahana, Alice K. Henning, M. Roy First, William E. Fitzsimmons, Kim Salm, Diane Tolzman

Research output: Contribution to journalReview article

17 Citations (Scopus)

Abstract

Background: Chronic renal allograft failure (CRAF) is the leading cause of graft loss post-renal transplantation. This study evaluated the efficacy and safety of tacrolimus as secondary intervention in cyclosporine-treated kidney transplantation patients with impaired allograft function as indicated by elevated serum creatinine (SCr) levels. Methods: Patients receiving cyclosporine-based immunosuppression who had an elevated SCr at least 3 months post-renal transplantation were enrolled. Treatment allocation was 2:1 to switch to tacrolimus or continue cyclosporine. This analysis was performed after 2 yr; patients will be followed for an additional 3 yr. Results: There were 186 enrolled and evaluable patients. On baseline biopsy, 90% of patients had chronic allograft nephropathy. Baseline median SCr was 2.5 mg/dL in both treatment groups. For patients with graft function at month 24, SCr had decreased to 2.3 mg/dL in the tacrolimus-treated patients and increased to 2.6 mg/dL in the cyclosporine-treated patients (p = 0.01). Acute rejection occurred in 4.8% of tacrolimus-treated patients and 5.0% of cyclosporine-treated patients during follow-up. Two-year allograft survival was comparable between groups (tacrolimus 69%, cyclosporine 67%; p = 0.70). Tacrolimus-treated patients had significantly lower cholesterol and low-density lipoprotein levels and also had fewer new-onset infections. Cardiac conditions developed in significantly fewer tacrolimus-treated patients (5.6%) than cyclosporine-treated patients (24.3%; p = 0.004). Glucose levels and the incidences of new-onset diabetes and new-onset hyperglycemia did not differ between treatment groups. Conclusions: Conversion from cyclosporine to tacrolimus results in improved renal function and lipid profiles, and significantly fewer cardiovascular events with no differences in the incidence of acute rejection or new-onset hyperglycemia.

Original languageEnglish (US)
Pages (from-to)573-580
Number of pages8
JournalClinical Transplantation
Volume19
Issue number5
DOIs
StatePublished - Oct 1 2005

Fingerprint

Tacrolimus
Cyclosporine
Chronic Kidney Failure
Allografts
Creatinine
Kidney Transplantation
Serum
Hyperglycemia
Transplants
Incidence
LDL Cholesterol
Immunosuppression
Therapeutics

Keywords

  • Cyclosporine
  • Graft rejection
  • Renal transplantation
  • Tacrolimus

ASJC Scopus subject areas

  • Transplantation

Cite this

Tacrolimus as secondary intervention vs. cyclosporine continuation in patients at risk for chronic renal allograft failure. / Waid, Thomas; Alfrey, Edward; Mulloy, Laura L; Shihab, Faud S.; Conti, David; Freeman, Richard; de Mattos, Angelo M.; Jensik, Stephen C.; Jordan, Stanley; Francos, George C.; Van Buren, David; Chan, Larry; Steiner, Robert W.; Basadonna, Giacomo; Brinker, Karl; Steinberg, Steven; Matas, Arthur J.; King, Anne L.; Kasiske, Bertram L.; Cohen, David J.; Surer, David; Inokuchi, Sharon; Pirsch, John D.; Bromberg, Jonathan S.; Weir, Matthew R.; Greenstein, Stuart M.; Tomlanovich, Stephen J.; Mendez, Robert; Kahana, Lawrence; Henning, Alice K.; First, M. Roy; Fitzsimmons, William E.; Salm, Kim; Tolzman, Diane.

In: Clinical Transplantation, Vol. 19, No. 5, 01.10.2005, p. 573-580.

Research output: Contribution to journalReview article

Waid, T, Alfrey, E, Mulloy, LL, Shihab, FS, Conti, D, Freeman, R, de Mattos, AM, Jensik, SC, Jordan, S, Francos, GC, Van Buren, D, Chan, L, Steiner, RW, Basadonna, G, Brinker, K, Steinberg, S, Matas, AJ, King, AL, Kasiske, BL, Cohen, DJ, Surer, D, Inokuchi, S, Pirsch, JD, Bromberg, JS, Weir, MR, Greenstein, SM, Tomlanovich, SJ, Mendez, R, Kahana, L, Henning, AK, First, MR, Fitzsimmons, WE, Salm, K & Tolzman, D 2005, 'Tacrolimus as secondary intervention vs. cyclosporine continuation in patients at risk for chronic renal allograft failure', Clinical Transplantation, vol. 19, no. 5, pp. 573-580. https://doi.org/10.1111/j.1399-0012.2005.00389.x
Waid, Thomas ; Alfrey, Edward ; Mulloy, Laura L ; Shihab, Faud S. ; Conti, David ; Freeman, Richard ; de Mattos, Angelo M. ; Jensik, Stephen C. ; Jordan, Stanley ; Francos, George C. ; Van Buren, David ; Chan, Larry ; Steiner, Robert W. ; Basadonna, Giacomo ; Brinker, Karl ; Steinberg, Steven ; Matas, Arthur J. ; King, Anne L. ; Kasiske, Bertram L. ; Cohen, David J. ; Surer, David ; Inokuchi, Sharon ; Pirsch, John D. ; Bromberg, Jonathan S. ; Weir, Matthew R. ; Greenstein, Stuart M. ; Tomlanovich, Stephen J. ; Mendez, Robert ; Kahana, Lawrence ; Henning, Alice K. ; First, M. Roy ; Fitzsimmons, William E. ; Salm, Kim ; Tolzman, Diane. / Tacrolimus as secondary intervention vs. cyclosporine continuation in patients at risk for chronic renal allograft failure. In: Clinical Transplantation. 2005 ; Vol. 19, No. 5. pp. 573-580.
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abstract = "Background: Chronic renal allograft failure (CRAF) is the leading cause of graft loss post-renal transplantation. This study evaluated the efficacy and safety of tacrolimus as secondary intervention in cyclosporine-treated kidney transplantation patients with impaired allograft function as indicated by elevated serum creatinine (SCr) levels. Methods: Patients receiving cyclosporine-based immunosuppression who had an elevated SCr at least 3 months post-renal transplantation were enrolled. Treatment allocation was 2:1 to switch to tacrolimus or continue cyclosporine. This analysis was performed after 2 yr; patients will be followed for an additional 3 yr. Results: There were 186 enrolled and evaluable patients. On baseline biopsy, 90{\%} of patients had chronic allograft nephropathy. Baseline median SCr was 2.5 mg/dL in both treatment groups. For patients with graft function at month 24, SCr had decreased to 2.3 mg/dL in the tacrolimus-treated patients and increased to 2.6 mg/dL in the cyclosporine-treated patients (p = 0.01). Acute rejection occurred in 4.8{\%} of tacrolimus-treated patients and 5.0{\%} of cyclosporine-treated patients during follow-up. Two-year allograft survival was comparable between groups (tacrolimus 69{\%}, cyclosporine 67{\%}; p = 0.70). Tacrolimus-treated patients had significantly lower cholesterol and low-density lipoprotein levels and also had fewer new-onset infections. Cardiac conditions developed in significantly fewer tacrolimus-treated patients (5.6{\%}) than cyclosporine-treated patients (24.3{\%}; p = 0.004). Glucose levels and the incidences of new-onset diabetes and new-onset hyperglycemia did not differ between treatment groups. Conclusions: Conversion from cyclosporine to tacrolimus results in improved renal function and lipid profiles, and significantly fewer cardiovascular events with no differences in the incidence of acute rejection or new-onset hyperglycemia.",
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TY - JOUR

T1 - Tacrolimus as secondary intervention vs. cyclosporine continuation in patients at risk for chronic renal allograft failure

AU - Waid, Thomas

AU - Alfrey, Edward

AU - Mulloy, Laura L

AU - Shihab, Faud S.

AU - Conti, David

AU - Freeman, Richard

AU - de Mattos, Angelo M.

AU - Jensik, Stephen C.

AU - Jordan, Stanley

AU - Francos, George C.

AU - Van Buren, David

AU - Chan, Larry

AU - Steiner, Robert W.

AU - Basadonna, Giacomo

AU - Brinker, Karl

AU - Steinberg, Steven

AU - Matas, Arthur J.

AU - King, Anne L.

AU - Kasiske, Bertram L.

AU - Cohen, David J.

AU - Surer, David

AU - Inokuchi, Sharon

AU - Pirsch, John D.

AU - Bromberg, Jonathan S.

AU - Weir, Matthew R.

AU - Greenstein, Stuart M.

AU - Tomlanovich, Stephen J.

AU - Mendez, Robert

AU - Kahana, Lawrence

AU - Henning, Alice K.

AU - First, M. Roy

AU - Fitzsimmons, William E.

AU - Salm, Kim

AU - Tolzman, Diane

PY - 2005/10/1

Y1 - 2005/10/1

N2 - Background: Chronic renal allograft failure (CRAF) is the leading cause of graft loss post-renal transplantation. This study evaluated the efficacy and safety of tacrolimus as secondary intervention in cyclosporine-treated kidney transplantation patients with impaired allograft function as indicated by elevated serum creatinine (SCr) levels. Methods: Patients receiving cyclosporine-based immunosuppression who had an elevated SCr at least 3 months post-renal transplantation were enrolled. Treatment allocation was 2:1 to switch to tacrolimus or continue cyclosporine. This analysis was performed after 2 yr; patients will be followed for an additional 3 yr. Results: There were 186 enrolled and evaluable patients. On baseline biopsy, 90% of patients had chronic allograft nephropathy. Baseline median SCr was 2.5 mg/dL in both treatment groups. For patients with graft function at month 24, SCr had decreased to 2.3 mg/dL in the tacrolimus-treated patients and increased to 2.6 mg/dL in the cyclosporine-treated patients (p = 0.01). Acute rejection occurred in 4.8% of tacrolimus-treated patients and 5.0% of cyclosporine-treated patients during follow-up. Two-year allograft survival was comparable between groups (tacrolimus 69%, cyclosporine 67%; p = 0.70). Tacrolimus-treated patients had significantly lower cholesterol and low-density lipoprotein levels and also had fewer new-onset infections. Cardiac conditions developed in significantly fewer tacrolimus-treated patients (5.6%) than cyclosporine-treated patients (24.3%; p = 0.004). Glucose levels and the incidences of new-onset diabetes and new-onset hyperglycemia did not differ between treatment groups. Conclusions: Conversion from cyclosporine to tacrolimus results in improved renal function and lipid profiles, and significantly fewer cardiovascular events with no differences in the incidence of acute rejection or new-onset hyperglycemia.

AB - Background: Chronic renal allograft failure (CRAF) is the leading cause of graft loss post-renal transplantation. This study evaluated the efficacy and safety of tacrolimus as secondary intervention in cyclosporine-treated kidney transplantation patients with impaired allograft function as indicated by elevated serum creatinine (SCr) levels. Methods: Patients receiving cyclosporine-based immunosuppression who had an elevated SCr at least 3 months post-renal transplantation were enrolled. Treatment allocation was 2:1 to switch to tacrolimus or continue cyclosporine. This analysis was performed after 2 yr; patients will be followed for an additional 3 yr. Results: There were 186 enrolled and evaluable patients. On baseline biopsy, 90% of patients had chronic allograft nephropathy. Baseline median SCr was 2.5 mg/dL in both treatment groups. For patients with graft function at month 24, SCr had decreased to 2.3 mg/dL in the tacrolimus-treated patients and increased to 2.6 mg/dL in the cyclosporine-treated patients (p = 0.01). Acute rejection occurred in 4.8% of tacrolimus-treated patients and 5.0% of cyclosporine-treated patients during follow-up. Two-year allograft survival was comparable between groups (tacrolimus 69%, cyclosporine 67%; p = 0.70). Tacrolimus-treated patients had significantly lower cholesterol and low-density lipoprotein levels and also had fewer new-onset infections. Cardiac conditions developed in significantly fewer tacrolimus-treated patients (5.6%) than cyclosporine-treated patients (24.3%; p = 0.004). Glucose levels and the incidences of new-onset diabetes and new-onset hyperglycemia did not differ between treatment groups. Conclusions: Conversion from cyclosporine to tacrolimus results in improved renal function and lipid profiles, and significantly fewer cardiovascular events with no differences in the incidence of acute rejection or new-onset hyperglycemia.

KW - Cyclosporine

KW - Graft rejection

KW - Renal transplantation

KW - Tacrolimus

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