BACKGROUND:Calcineurin inhibitor (CNI) and steroid (ST) withdrawal are strategies under investigation to reduce long-term toxicities associated with current immunosuppressive regimens. We conducted a single center, prospective trial comparing the efficacy and safety of CNI or ST withdrawal in kidney transplant recipients receiving sirolimus-based immunosuppressive regimen. METHODS:Forty-seven recipients of first renal transplant with non-HLA-identical living donors receivedsirolimus (SRL), tacrolimus (TAC), and ST without induction therapy and were randomized to undergo ST (TAC/SRLgroup, n = 24) orTAC (SRL/ST group, n = 21) withdrawal 3 months after transplantation. Primary efficacy and safety endpoints were the incidence of biopsy-confirmed acute rejection (BCAR) and renal function at 12 months. RESULTS: No differences were observed in the incidence of BCAR (4.2% vs. 9.5%), graft (95.8% vs. 95.6%), and patient (95.8% vs. 95.6%) survivals or in renal function (60 ± 11.5 vs. 63.4 ± 10.5 ml/min, P = 0.361). Higher mean cholesterol concentration was observed in the SRL/ST group (191.9 ± 63.3 vs. 241.6 ± 61.5 mg/dl, P = 0.019). Treatment discontinuation due to adverse events occurred in 12.5% of patients in TAC/SRL group and 21.7% in SRL/ST group. CONCLUSION: Within this short period of observation, our study was unable to detect any significant difference in major transplant outcomes comparing CNI and ST elimination strategies.
RCT Entities:
BACKGROUND:Calcineurin inhibitor (CNI) and steroid (ST) withdrawal are strategies under investigation to reduce long-term toxicities associated with current immunosuppressive regimens. We conducted a single center, prospective trial comparing the efficacy and safety of CNI or ST withdrawal in kidney transplant recipients receiving sirolimus-based immunosuppressive regimen. METHODS: Forty-seven recipients of first renal transplant with non-HLA-identical living donors received sirolimus (SRL), tacrolimus (TAC), and ST without induction therapy and were randomized to undergo ST (TAC/SRL group, n = 24) or TAC (SRL/ST group, n = 21) withdrawal 3 months after transplantation. Primary efficacy and safety endpoints were the incidence of biopsy-confirmed acute rejection (BCAR) and renal function at 12 months. RESULTS: No differences were observed in the incidence of BCAR (4.2% vs. 9.5%), graft (95.8% vs. 95.6%), and patient (95.8% vs. 95.6%) survivals or in renal function (60 ± 11.5 vs. 63.4 ± 10.5 ml/min, P = 0.361). Higher mean cholesterol concentration was observed in the SRL/ST group (191.9 ± 63.3 vs. 241.6 ± 61.5 mg/dl, P = 0.019). Treatment discontinuation due to adverse events occurred in 12.5% of patients in TAC/SRL group and 21.7% in SRL/ST group. CONCLUSION: Within this short period of observation, our study was unable to detect any significant difference in major transplant outcomes comparing CNI and ST elimination strategies.
Authors: Barry D Kahan; Yarkin K Yakupoglu; Linda Schoenberg; Richard J Knight; Stephen M Katz; Deijan Lai; Charles T Van Buren Journal: Transplantation Date: 2005-09-27 Impact factor: 4.939
Authors: E Steve Woodle; Flavio Vincenti; Marc I Lorber; H Albin Gritsch; Donald Hricik; Kenneth Washburn; Arthur J Matas; Michael Gallichio; John Neylan Journal: Am J Transplant Date: 2005-01 Impact factor: 8.086
Authors: John F Valente; Donald Hricik; Kelly Weigel; David Seaman; Thomas Knauss; Christopher T Siegel; Kenneth Bodziak; James A Schulak Journal: Am J Transplant Date: 2003-09 Impact factor: 8.086
Authors: Muhammad Abdul Mabood Khalil; Saeed M G Al-Ghamdi; Ubaidullah Shaik Dawood; Said Sayed Ahmed Khamis; Hideki Ishida; Vui Heng Chong; Jackson Tan Journal: J Transplant Date: 2022-02-28