Document Detail

High incidence of rejection episodes and poor tolerance of sirolimus in a protocol with early steroid withdrawal and calcineurin inhibitor-free maintenance therapy in renal transplantation: experiences of a randomized prospective single-center study.
MedLine Citation:
PMID:  23195006     Owner:  NLM     Status:  MEDLINE    
Immunosuppressive maintenance therapy after kidney transplantation leads to various undesired side effects such as calcineurin inhibitor (CNI)-associated nephrotoxicity or elevated cardiovascular risk due to posttransplantation diabetes and hypertension. These effects show negative impacts on long-term allograft function as well as patient morbidity and mortality. Therefore, we used an immunosuppressive regimen with early corticosteroid withdrawal (ESW), maintenance therapy containing tacrolimus, sirolimus (SRL), and mycophenolate sodium for 3 months followed by a prospective randomized trial comparing a CNI free versus a low-dose CNI therapy. The primary endpoint was 6-month graft function. Among 75 patients, ESW was performed after 4 days in 65 patients. Over the following 3 months before randomization to CNI-free maintenance therapy, we experienced a high number (25%) of SRL discontinuations due to adverse events, including leukopenia, anemia, arthritis, and pneumonitis. In addition there were significantly more allograft rejection episodes in the CNI-free group (P = .017) during the study period leading to a switch from SRL to a CNI. Despite the higher rate of rejection episodes in the CNI-free groups, glomerular filtration rates (GFR) at 6 months were comparable between the study groups (P = .25). After 1 year only 9.2% (6/65) of all patients treated with SRL remained on this drug. Conclusion, there was an unacceptably high rate of SRL intolerance using an ESW and CNI-free immunosuppressive regimen combined with a significantly higher rate of rejection episodes.
F Burkhalter; T Oettl; B Descoeudres; A Bachmann; L Guerke; M J Mihatsch; M Dickenmann; J Steiger
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Transplantation proceedings     Volume:  44     ISSN:  1873-2623     ISO Abbreviation:  Transplant. Proc.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-11-30     Completed Date:  2013-05-13     Revised Date:  2013-05-29    
Medline Journal Info:
Nlm Unique ID:  0243532     Medline TA:  Transplant Proc     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2961-5     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Elsevier Inc. All rights reserved.
Clinic for Transplant Immunology and Nephrology, University Hospital Basel, Basel, Switzerland.
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MeSH Terms
Adrenal Cortex Hormones / administration & dosage*,  adverse effects
Calcineurin / antagonists & inhibitors*
Chi-Square Distribution
Drug Administration Schedule
Drug Substitution
Drug Therapy, Combination
Glomerular Filtration Rate / drug effects
Graft Rejection / epidemiology,  immunology,  prevention & control*
Graft Survival / drug effects*
Immunosuppressive Agents / administration & dosage*,  adverse effects
Kidney Transplantation / adverse effects,  immunology*
Middle Aged
Mycophenolic Acid / administration & dosage,  analogs & derivatives
Prospective Studies
Sirolimus / administration & dosage*,  adverse effects
Switzerland / epidemiology
Tacrolimus / administration & dosage
Time Factors
Treatment Outcome
Young Adult
Reg. No./Substance:
0/Adrenal Cortex Hormones; 0/Immunosuppressive Agents; 109581-93-3/Tacrolimus; 24280-93-1/Mycophenolic Acid; 53123-88-9/Sirolimus; 9242ECW6R0/mycophenolate mofetil; EC

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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