Abstract
The optimal long-term regimen for immunosuppression for kidney transplant recipients is unknown. We conducted a randomized trial involving 150 kidney transplant recipients to compare tacrolimus/sirolimus, tacrolimus/mycophenolate mofetil (MMF), and cyclosporine/sirolimus. All patients received daclizumab induction and maintenance corticosteroids. Median follow-up was 8 yr post-transplant. Acute rejection (AR) occurred significantly less often among those treated with tacrolimus/MMF (12%) than among those treated with tacrolimus/sirolimus (30%) or cyclosporine/sirolimus (28%). Mean estimated GFR was consistently higher in the tacrolimus/MMF arm, especially after controlling for donor age in a multivariable model during the first 36 mo (P ≲ 0.008). The rate of dying with a functioning graft was significantly higher among those treated with tacrolimus/sirolimus (26%) than among those treated with tacrolimus/ MMF (12%) or cyclosporine/sirolimus (4%). We did not observe significant differences in actuarial graft survival at 8 yr post-transplant between the groups. Patient noncompliance seemed responsible for 45% (13/29) of observed graft failures, with 11 of these occurring after 36 mo. Significantly more viral infections, protocol violations, and need for antilipid therapy occurred among patients receiving sirolimus, but we did not observe differences between the groups with regard to infections requiring hospitalization or new-onset diabetes. Taken together, these results suggest that maintenance therapy with tacrolimus/MMF is more favorable than either tacrolimus/sirolimus or cyclosporine/sirolimus.
| Original language | English |
|---|---|
| Pages (from-to) | 1758-1768 |
| Number of pages | 11 |
| Journal | Journal of the American Society of Nephrology |
| Volume | 22 |
| Issue number | 9 |
| DOIs | |
| State | Published - Sep 1 2011 |
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ASJC Scopus subject areas
- Nephrology
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Randomized trial of immunosuppressive regimens in renal transplantation. / Guerra, Giselle; Ciancio, Gaetano; Gaynor, Jeffrey; Zarak, Alberto; Brown, Randolph; Hanson, Lois; Sageshima, Junichiro; Roth, David; Chen, Linda J; Kupin, Warren; Tueros, Lissett; Ruiz, Phillip; Livingstone, Alan; Burke, George W.
In: Journal of the American Society of Nephrology, Vol. 22, No. 9, 01.09.2011, p. 1758-1768.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Randomized trial of immunosuppressive regimens in renal transplantation
AU - Guerra, Giselle
AU - Ciancio, Gaetano
AU - Gaynor, Jeffrey
AU - Zarak, Alberto
AU - Brown, Randolph
AU - Hanson, Lois
AU - Sageshima, Junichiro
AU - Roth, David
AU - Chen, Linda J
AU - Kupin, Warren
AU - Tueros, Lissett
AU - Ruiz, Phillip
AU - Livingstone, Alan
AU - Burke, George W
PY - 2011/9/1
Y1 - 2011/9/1
N2 - The optimal long-term regimen for immunosuppression for kidney transplant recipients is unknown. We conducted a randomized trial involving 150 kidney transplant recipients to compare tacrolimus/sirolimus, tacrolimus/mycophenolate mofetil (MMF), and cyclosporine/sirolimus. All patients received daclizumab induction and maintenance corticosteroids. Median follow-up was 8 yr post-transplant. Acute rejection (AR) occurred significantly less often among those treated with tacrolimus/MMF (12%) than among those treated with tacrolimus/sirolimus (30%) or cyclosporine/sirolimus (28%). Mean estimated GFR was consistently higher in the tacrolimus/MMF arm, especially after controlling for donor age in a multivariable model during the first 36 mo (P ≲ 0.008). The rate of dying with a functioning graft was significantly higher among those treated with tacrolimus/sirolimus (26%) than among those treated with tacrolimus/ MMF (12%) or cyclosporine/sirolimus (4%). We did not observe significant differences in actuarial graft survival at 8 yr post-transplant between the groups. Patient noncompliance seemed responsible for 45% (13/29) of observed graft failures, with 11 of these occurring after 36 mo. Significantly more viral infections, protocol violations, and need for antilipid therapy occurred among patients receiving sirolimus, but we did not observe differences between the groups with regard to infections requiring hospitalization or new-onset diabetes. Taken together, these results suggest that maintenance therapy with tacrolimus/MMF is more favorable than either tacrolimus/sirolimus or cyclosporine/sirolimus.
AB - The optimal long-term regimen for immunosuppression for kidney transplant recipients is unknown. We conducted a randomized trial involving 150 kidney transplant recipients to compare tacrolimus/sirolimus, tacrolimus/mycophenolate mofetil (MMF), and cyclosporine/sirolimus. All patients received daclizumab induction and maintenance corticosteroids. Median follow-up was 8 yr post-transplant. Acute rejection (AR) occurred significantly less often among those treated with tacrolimus/MMF (12%) than among those treated with tacrolimus/sirolimus (30%) or cyclosporine/sirolimus (28%). Mean estimated GFR was consistently higher in the tacrolimus/MMF arm, especially after controlling for donor age in a multivariable model during the first 36 mo (P ≲ 0.008). The rate of dying with a functioning graft was significantly higher among those treated with tacrolimus/sirolimus (26%) than among those treated with tacrolimus/ MMF (12%) or cyclosporine/sirolimus (4%). We did not observe significant differences in actuarial graft survival at 8 yr post-transplant between the groups. Patient noncompliance seemed responsible for 45% (13/29) of observed graft failures, with 11 of these occurring after 36 mo. Significantly more viral infections, protocol violations, and need for antilipid therapy occurred among patients receiving sirolimus, but we did not observe differences between the groups with regard to infections requiring hospitalization or new-onset diabetes. Taken together, these results suggest that maintenance therapy with tacrolimus/MMF is more favorable than either tacrolimus/sirolimus or cyclosporine/sirolimus.
UR - http://www.scopus.com/inward/record.url?scp=80052317076&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=80052317076&partnerID=8YFLogxK
U2 - 10.1681/ASN.2011010006
DO - 10.1681/ASN.2011010006
M3 - Article
C2 - 21807891
AN - SCOPUS:80052317076
VL - 22
SP - 1758
EP - 1768
JO - Journal of the American Society of Nephrology
JF - Journal of the American Society of Nephrology
SN - 1046-6673
IS - 9
ER -