Document Detail

Improved renal function, with similar proteinuria, after two years of early tacrolimus withdrawal from a regimen of sirolimus plus tacrolimus.
MedLine Citation:
PMID:  18724234     Owner:  NLM     Status:  MEDLINE    
Results at 1 year of a pilot randomized trial with 87 kidney graft recipients, comparing the maintenance treatment with sirolimus, tacrolimus and steroids (group I) versus tacrolimus withdrawal since the third month onward, followed by maintenance with SRL and steroids (group II) have shown that early elimination of tacrolimus may result in improved renal function and blood pressure control. At 2 years, 26 and 25 patients in groups I and II, respectively, were analyzed in an on-therapy and an ITT analysis. In the on-therapy analysis, group II showed lower serum creatinine (1.3+/-0.2 vs. 1.6+/-0.6 mg/dL) and lower diastolic blood pressure (74+/-9 vs. 80+/-11 mm Hg). No acute rejections occurred during the second year of follow-up. In more than 90% of patients, proteinuria was less than 1 g/d, and in 50% it was negative. In the ITT analysis, differences were found only in diastolic blood pressure (80+/-10 vs. 74+/-8 mm Hg in groups I and II respectively, P=0.009). Tacrolimus withdrawal from a combination of sirolimus and tacrolimus, in selected patients, may be observed at 2 years by an improvement in renal function and blood pressure without a higher incidence of proteinuria.
José M Morales; Josep M Grinyó; Josep M Campistol; Javier García-Martínez; Manuel Arias; Javier Paul; Ana Sánchez-Fructuoso; Mercé Brunet; Enrique Granados; Jorge A Munoz-Robles
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Transplantation     Volume:  86     ISSN:  1534-6080     ISO Abbreviation:  Transplantation     Publication Date:  2008 Aug 
Date Detail:
Created Date:  2008-08-25     Completed Date:  2008-09-25     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0132144     Medline TA:  Transplantation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  620-2     Citation Subset:  IM    
Nephrology Department, Hospital 12 de Octubre, Madrid, Spain.
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MeSH Terms
Adrenal Cortex Hormones / therapeutic use
Creatinine / blood*
Drug Administration Schedule
Drug Therapy, Combination
Follow-Up Studies
Glomerular Filtration Rate / drug effects
Immunosuppressive Agents / therapeutic use
Kidney Function Tests*
Pilot Projects
Proteinuria / chemically induced,  epidemiology*
Sirolimus / therapeutic use*
Tacrolimus / administration & dosage,  therapeutic use*
Time Factors
Reg. No./Substance:
0/Adrenal Cortex Hormones; 0/Immunosuppressive Agents; 109581-93-3/Tacrolimus; 53123-88-9/Sirolimus; 60-27-5/Creatinine

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

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