Sirolimus/steroids maintenance therapy after early cyclosporine withdrawal: 12-month efficacy and safety results of multicenter single arm pilot study in primary renal allograft recipients in Korea

Man Ki Ju, Duck Jong Han, Soo Jin Kim, In Sung Moon, Yong Lim Kim, Hyun Chul Kim, Seong Joo Kim, Sang Joon Kim, Soon Il Kim, Yeong Hoon Kim, Chang Kwon Oh, Yu Seun Kim

Research output: Contribution to journalArticle

Abstract

Purpose: Sirolimus has potent anti-rejection activity as well as the ability to prolong allograft survival and reduce nephrotoxicity. This study was designed to evaluate the efficacy and safety of sirolimus in Korean de novo renal transplantation. Methods: We included 79 patients who received sirolimus at nine Korean transplantation centers in the intention-to-treat and valid-for-safety analyses. The study was an open, single treatment arm multicenter trial with 12 months of patient follow-up. Initially, patients received 2 mg of sirolimus (after 6 mg of loading does) with cyclosporine and steroids. Sirolimus was administered for up to 12 months. Antibody induction was not used. At 3 months after transplantation, cyclosporine was progressively withdrawn over 4 to 8 weeks while sirolimus was adjusted to obtain trough concentrations within 15∼30 ng/ml up to 6 months and concentrations within 12∼24 ng/ml between 7 and 12 months. Results: The proportion of patients who completed the 12-month sirolimus medication per protocol was 74.7% (59/79). Cyclosporine withdrawal was possible in 64 recipients (81.0%). Fifteen patients discontinued sirolimus before cyclosporine withdrawal, and 5 recipients did so after successful cyclosporine withdrawal. Most common causes of sirolimus discontinuation were graft rejection (n=8). Incidence of biopsy-proven acute rejection within 6 months after transplantation was 15.2%. Patient and graft survival rates at 12 months post transplantation were 97.5% and 96.2%, respectively. During the study period, three graft losses occurred by patient death. Conclusion: Based on this study, cyclosporine and sirolimus induction followed by cyclosporine withdrawal at 3 months post-transplant is considered to be efficient and safe after primary renal transplantation.

Original languageEnglish
Pages (from-to)261-266
Number of pages6
JournalJournal of the Korean Surgical Society
Volume79
Issue number4
DOIs
Publication statusPublished - 2010 Oct 1

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Sirolimus
Korea
Cyclosporine
Allografts
Arm
Steroids
Kidney
Safety
Transplantation
Therapeutics
Kidney Transplantation
Transplants
Aptitude
Graft Rejection
Graft Survival
Multicenter Studies
Survival Rate
Biopsy
Antibodies
Incidence

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

Ju, Man Ki ; Han, Duck Jong ; Kim, Soo Jin ; Moon, In Sung ; Kim, Yong Lim ; Kim, Hyun Chul ; Kim, Seong Joo ; Kim, Sang Joon ; Kim, Soon Il ; Kim, Yeong Hoon ; Oh, Chang Kwon ; Kim, Yu Seun. / Sirolimus/steroids maintenance therapy after early cyclosporine withdrawal : 12-month efficacy and safety results of multicenter single arm pilot study in primary renal allograft recipients in Korea. In: Journal of the Korean Surgical Society. 2010 ; Vol. 79, No. 4. pp. 261-266.
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abstract = "Purpose: Sirolimus has potent anti-rejection activity as well as the ability to prolong allograft survival and reduce nephrotoxicity. This study was designed to evaluate the efficacy and safety of sirolimus in Korean de novo renal transplantation. Methods: We included 79 patients who received sirolimus at nine Korean transplantation centers in the intention-to-treat and valid-for-safety analyses. The study was an open, single treatment arm multicenter trial with 12 months of patient follow-up. Initially, patients received 2 mg of sirolimus (after 6 mg of loading does) with cyclosporine and steroids. Sirolimus was administered for up to 12 months. Antibody induction was not used. At 3 months after transplantation, cyclosporine was progressively withdrawn over 4 to 8 weeks while sirolimus was adjusted to obtain trough concentrations within 15∼30 ng/ml up to 6 months and concentrations within 12∼24 ng/ml between 7 and 12 months. Results: The proportion of patients who completed the 12-month sirolimus medication per protocol was 74.7{\%} (59/79). Cyclosporine withdrawal was possible in 64 recipients (81.0{\%}). Fifteen patients discontinued sirolimus before cyclosporine withdrawal, and 5 recipients did so after successful cyclosporine withdrawal. Most common causes of sirolimus discontinuation were graft rejection (n=8). Incidence of biopsy-proven acute rejection within 6 months after transplantation was 15.2{\%}. Patient and graft survival rates at 12 months post transplantation were 97.5{\%} and 96.2{\%}, respectively. During the study period, three graft losses occurred by patient death. Conclusion: Based on this study, cyclosporine and sirolimus induction followed by cyclosporine withdrawal at 3 months post-transplant is considered to be efficient and safe after primary renal transplantation.",
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Sirolimus/steroids maintenance therapy after early cyclosporine withdrawal : 12-month efficacy and safety results of multicenter single arm pilot study in primary renal allograft recipients in Korea. / Ju, Man Ki; Han, Duck Jong; Kim, Soo Jin; Moon, In Sung; Kim, Yong Lim; Kim, Hyun Chul; Kim, Seong Joo; Kim, Sang Joon; Kim, Soon Il; Kim, Yeong Hoon; Oh, Chang Kwon; Kim, Yu Seun.

In: Journal of the Korean Surgical Society, Vol. 79, No. 4, 01.10.2010, p. 261-266.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Sirolimus/steroids maintenance therapy after early cyclosporine withdrawal

T2 - 12-month efficacy and safety results of multicenter single arm pilot study in primary renal allograft recipients in Korea

AU - Ju, Man Ki

AU - Han, Duck Jong

AU - Kim, Soo Jin

AU - Moon, In Sung

AU - Kim, Yong Lim

AU - Kim, Hyun Chul

AU - Kim, Seong Joo

AU - Kim, Sang Joon

AU - Kim, Soon Il

AU - Kim, Yeong Hoon

AU - Oh, Chang Kwon

AU - Kim, Yu Seun

PY - 2010/10/1

Y1 - 2010/10/1

N2 - Purpose: Sirolimus has potent anti-rejection activity as well as the ability to prolong allograft survival and reduce nephrotoxicity. This study was designed to evaluate the efficacy and safety of sirolimus in Korean de novo renal transplantation. Methods: We included 79 patients who received sirolimus at nine Korean transplantation centers in the intention-to-treat and valid-for-safety analyses. The study was an open, single treatment arm multicenter trial with 12 months of patient follow-up. Initially, patients received 2 mg of sirolimus (after 6 mg of loading does) with cyclosporine and steroids. Sirolimus was administered for up to 12 months. Antibody induction was not used. At 3 months after transplantation, cyclosporine was progressively withdrawn over 4 to 8 weeks while sirolimus was adjusted to obtain trough concentrations within 15∼30 ng/ml up to 6 months and concentrations within 12∼24 ng/ml between 7 and 12 months. Results: The proportion of patients who completed the 12-month sirolimus medication per protocol was 74.7% (59/79). Cyclosporine withdrawal was possible in 64 recipients (81.0%). Fifteen patients discontinued sirolimus before cyclosporine withdrawal, and 5 recipients did so after successful cyclosporine withdrawal. Most common causes of sirolimus discontinuation were graft rejection (n=8). Incidence of biopsy-proven acute rejection within 6 months after transplantation was 15.2%. Patient and graft survival rates at 12 months post transplantation were 97.5% and 96.2%, respectively. During the study period, three graft losses occurred by patient death. Conclusion: Based on this study, cyclosporine and sirolimus induction followed by cyclosporine withdrawal at 3 months post-transplant is considered to be efficient and safe after primary renal transplantation.

AB - Purpose: Sirolimus has potent anti-rejection activity as well as the ability to prolong allograft survival and reduce nephrotoxicity. This study was designed to evaluate the efficacy and safety of sirolimus in Korean de novo renal transplantation. Methods: We included 79 patients who received sirolimus at nine Korean transplantation centers in the intention-to-treat and valid-for-safety analyses. The study was an open, single treatment arm multicenter trial with 12 months of patient follow-up. Initially, patients received 2 mg of sirolimus (after 6 mg of loading does) with cyclosporine and steroids. Sirolimus was administered for up to 12 months. Antibody induction was not used. At 3 months after transplantation, cyclosporine was progressively withdrawn over 4 to 8 weeks while sirolimus was adjusted to obtain trough concentrations within 15∼30 ng/ml up to 6 months and concentrations within 12∼24 ng/ml between 7 and 12 months. Results: The proportion of patients who completed the 12-month sirolimus medication per protocol was 74.7% (59/79). Cyclosporine withdrawal was possible in 64 recipients (81.0%). Fifteen patients discontinued sirolimus before cyclosporine withdrawal, and 5 recipients did so after successful cyclosporine withdrawal. Most common causes of sirolimus discontinuation were graft rejection (n=8). Incidence of biopsy-proven acute rejection within 6 months after transplantation was 15.2%. Patient and graft survival rates at 12 months post transplantation were 97.5% and 96.2%, respectively. During the study period, three graft losses occurred by patient death. Conclusion: Based on this study, cyclosporine and sirolimus induction followed by cyclosporine withdrawal at 3 months post-transplant is considered to be efficient and safe after primary renal transplantation.

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