Document Detail


Tacrolimus monotherapy following alemtuzumab induction in combined kidney-pancreas transplantation: results of a prospective randomized trial.
MedLine Citation:
PMID:  23274323     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: We investigated the safety and efficacy of Campath induction and tacrolimus (TAC) maintenance therapy compared to ATG induction with TAC +MMF + steroids in de novo kidney-pancreas transplanted patients.
MATERIAL/METHODS: 14 patients (Group A) received Campath 30 mg + methylprednisolone 500 mg before revascularization followed by TAC monotherapy, and 16 patients (Group B) ATG 8 mg/kg with TAC + MMF+ steroids (withdrawn at month 3). TAC trough levels (ng/mL) of 12-15 were aimed for in both groups until month 6 and thereafter 6-12.
RESULTS: 1-year patient survival was 100% in both groups; kidney and pancreas survival in Group A was 93% each. In Group B 1-year kidney and pancreas survival was 100% and 87%, respectively. A total of three pancreas grafts were lost due to thrombosis of the graft vein within the first month. The only kidney loss was due to initial non-function. All biopsy-proven acute rejections of renal transplants (n=3 in Group A, n=0 in Group B) were reversible. No acute pancreas graft rejection was demonstrated. Infectious complications, lipid metabolism and blood pressure were comparable in both groups, as were other adverse events. No tumor occurred. At 12 months 13 patients in each group were steroid-free; the mean serum creatinine level was 1.44 mg/dL in Group A and 1.33 mg/dL in Group B. All patients were exogenous insulin-free.
CONCLUSIONS: At one year efficacy and safety of Campath +TAC monotherapy were comparable to those of ATG + TAC + MMF + steroids in a limited number of combined kidney-pancreas transplant recipients.
Authors:
Claudia Bösmüller; Robert Ollinger; Michael Sieb; Annemarie Weissenbacher; Stefan Schneeberger; Johann Pratschke; Raimund Margreiter
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Annals of transplantation : quarterly of the Polish Transplantation Society     Volume:  17     ISSN:  2329-0358     ISO Abbreviation:  Ann. Transplant.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-31     Completed Date:  2013-05-28     Revised Date:  2013-06-17    
Medline Journal Info:
Nlm Unique ID:  9802544     Medline TA:  Ann Transplant     Country:  Poland    
Other Details:
Languages:  eng     Pagination:  45-51     Citation Subset:  IM    
Affiliation:
Department of Visceral, Transplant and Thoracic Surgery, Center of Operative Medicine, Innsbruck Medical University, Anichstrasse 35, Innsbruck, Austria. claudia.boesmueller@uki.at
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Antibodies, Monoclonal, Humanized / therapeutic use*
Antilymphocyte Serum / therapeutic use
Diabetes Mellitus, Type 1 / complications
Drug Administration Schedule
Drug Therapy, Combination
Female
Follow-Up Studies
Graft Rejection / prevention & control*
Graft Survival
Humans
Immunosuppressive Agents / therapeutic use*
Induction Chemotherapy / methods
Kaplan-Meier Estimate
Kidney Failure, Chronic / etiology,  surgery*
Kidney Transplantation / immunology*
Maintenance Chemotherapy / methods
Male
Methylprednisolone / therapeutic use
Middle Aged
Mycophenolic Acid / analogs & derivatives,  therapeutic use
Pancreas Transplantation / immunology*
Prospective Studies
Tacrolimus / therapeutic use*
Treatment Outcome
Young Adult
Chemical
Reg. No./Substance:
0/Antibodies, Monoclonal, Humanized; 0/Antilymphocyte Serum; 0/Immunosuppressive Agents; 109581-93-3/Tacrolimus; 24280-93-1/Mycophenolic Acid; 3A189DH42V/alemtuzumab; 83-43-2/Methylprednisolone; 9242ECW6R0/mycophenolate mofetil

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


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