PMID- 21761129
OWN - NLM
STAT- MEDLINE
DCOM- 20120423
LR  - 20211203
IS  - 1573-2584 (Electronic)
IS  - 0301-1623 (Linking)
VI  - 43
IP  - 4
DP  - 2011 Dec
TI  - Steroid or tacrolimus withdrawal in renal transplant recipients using sirolimus.
PG  - 1221-8
LID - 10.1007/s11255-011-0001-3 [doi]
AB  - 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.
FAU - de Sandes Freitas, Taina Veras
AU  - de Sandes Freitas TV
AD  - Nephrology Division, Hospital do Rim e Hipertensao, Rua Borges Lagoa 960, 11 degrees  
      andar, Vila Clementino, 04038-002 Sao Paulo, Brazil. taina.sandes@medfarm.com.br
FAU - Harada, Kelly Miyuki
AU  - Harada KM
FAU - Felipe, Claudia Rosso
AU  - Felipe CR
FAU - Galante, Nelson Zocoler
AU  - Galante NZ
FAU - Sampaio, Edison Luiz Mandia
AU  - Sampaio EL
FAU - Ikehara, Edson
AU  - Ikehara E
FAU - Alfieri, Fernando
AU  - Alfieri F
FAU - Tedesco-Silva Junior, Helio
AU  - Tedesco-Silva Junior H
FAU - Medina-Pestana, Jose Osmar
AU  - Medina-Pestana JO
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110715
PL  - Netherlands
TA  - Int Urol Nephrol
JT  - International urology and nephrology
JID - 0262521
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Calcineurin Inhibitors)
RN  - 0 (Immunosuppressive Agents)
RN  - VB0R961HZT (Prednisone)
RN  - W36ZG6FT64 (Sirolimus)
RN  - WM0HAQ4WNM (Tacrolimus)
RN  - X4W7ZR7023 (Methylprednisolone)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Inflammatory Agents/*administration & dosage/adverse effects
MH  - Biopsy
MH  - *Calcineurin Inhibitors
MH  - Drug Therapy, Combination/adverse effects
MH  - Female
MH  - Graft Rejection/*pathology/prevention & control
MH  - Graft Survival
MH  - Humans
MH  - Immunosuppression Therapy/adverse effects/methods
MH  - Immunosuppressive Agents/*administration & dosage/adverse effects
MH  - Kaplan-Meier Estimate
MH  - *Kidney Transplantation/immunology/pathology
MH  - Male
MH  - Methylprednisolone/administration & dosage/adverse effects
MH  - Middle Aged
MH  - Prednisone/administration & dosage/adverse effects
MH  - Sirolimus/administration & dosage/adverse effects
MH  - Tacrolimus/administration & dosage/adverse effects
MH  - Young Adult
EDAT- 2011/07/16 06:00
MHDA- 2012/04/24 06:00
CRDT- 2011/07/16 06:00
PHST- 2010/10/18 00:00 [received]
PHST- 2011/05/14 00:00 [accepted]
PHST- 2011/07/16 06:00 [entrez]
PHST- 2011/07/16 06:00 [pubmed]
PHST- 2012/04/24 06:00 [medline]
AID - 10.1007/s11255-011-0001-3 [doi]
PST - ppublish
SO  - Int Urol Nephrol. 2011 Dec;43(4):1221-8. doi: 10.1007/s11255-011-0001-3. Epub 
      2011 Jul 15.