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      Call for Papers: Green Renal Replacement Therapy: Caring for the Environment

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      Induction Sirolimus and Delayed Graft Function after Deceased Donor Kidney Transplantation in the United States

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          Abstract

          Background/Aims: Previous studies have reported a link between the use of induction sirolimus (INDSRL) and delayed graft function (DGF) after kidney transplantation. However, none have had sufficient power to adjust for all factors known to be associated with DGF. Methods: We conducted a retrospective cohort study of US deceased donor kidney transplantation recipients in the United States Renal Data System (USRDS) from January 1, 2000 to May 31, 2001. Logistic regression analysis was used to model adjusted odds ratios (AOR) for the development of DGF, adjusted for other factors previously reported to be associated with DGF. Results: Among 8,319 patients meeting inclusion criteria, 361 patients received INDSRL, of whom 98 (27.1%) had DGF, compared to 22.5% among patients who did not receive INDSRL. In multivariate analysis, INDSRL was associated with an increased risk of DGF, with an adjusted odds ratio of 1.42 (95% CI: 1.07–1.90). Other factors associated with DGF were similar to those previously reported. INDSRL was not significantly associated with graft loss at 1 year in Cox regression. Conclusions: INDSRL was independently associated with DGF in US deceased donor kidney transplantation recipients, adjusted for all other factors previously shown to be associated with DGF.

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          A worldwide, phase III, randomized, controlled, safety and efficacy study of a sirolimus/cyclosporine regimen for prevention of acute rejection in recipients of primary mismatched renal allografts.

          Graeme Macdonald, (2001)
          Despite the various immunosuppressive regimens presently in use, acute rejection in the early postoperative period continues to occur in 20 to 40% of renal transplant patients. In a double-blind, multicentred study, we investigated the ability of two different doses of sirolimus (rapamycin, RAPAMUNE), a new class of immunosuppressant that blocks cell cycle progression, to prevent acute rejection in recipients of primary mismatched renal allografts when added to a regimen of cyclosporine (cyclosporin A, CsA) and corticosteroids. Between October 1996 and September 1997, 576 recipients of primary mismatched cadaveric or living donor renal allografts were randomly assigned in a 2:2:1 ratio (before the transplant operation) to receive an initial loading dose of either 6 or 15 mg of orally administered sirolimus, followed by a daily dose of either 2 or 5 mg/day, or to receive a matched placebo. All groups received cyclosporine (microemulsion formula, CsA) and corticosteroids. The primary endpoint was a composite of first occurrence of biopsy-confirmed acute rejection, graft loss, or death during the first 6 months after transplantation. Safety data were monitored by an independent drug safety monitoring board. Based on an intention-to-treat analysis of 576 patients, there were no significant differences in patient demographic or baseline characteristics among treatment groups. The overall rate of the primary composite endpoint for the 6-month period after transplantation was 30.0% (68/227) in the 2 mg/day sirolimus group and 25.6% (56/219) in the 5 mg/day sirolimus group, significantly lower than the 47.7% (62/130) in the placebo group (P=0.002, P<0.001, respectively). During this period, the incidence of biopsy-confirmed acute rejection was 24.7% (56/227) in the 2 mg/day sirolimus group and 19.2% (42/219) in the 5 mg/day sirolimus group, compared with 41.5% (54/130) in the placebo group (P=0.003, P<0.001, respectively), representing a significant reduction in acute rejection of 40.5 and 53.7%, respectively. The need for antibody therapy to treat the first episode of biopsy-confirmed acute rejection was significantly reduced in the 5 mg/ day sirolimus group (3.2%) compared to the placebo group (8.5%; P=0.044). The results 1 year after transplantation were similar for the efficacy parameters studied. Adverse events and infections occurred in all groups. The addition of either 2 mg/day sirolimus or 5 mg/day sirolimus to CsA/corticosteroid therapy significantly reduces the incidence of acute rejection episodes in primary mismatched renal allograft recipients, without an increase in immunosuppressant-related side effects, including infections and malignancy, at 6 months and at 1 year after transplantation.
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            Efficacy of sirolimus compared with azathioprine for reduction of acute renal allograft rejection: a randomised multicentre study

            Barry D Kahan (2000)
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              Nomogram for predicting the likelihood of delayed graft function in adult cadaveric renal transplant recipients.

              Art Owen, W Irish, Mark Schnitzler … (2003)
              Delayed graft function (DGF) is the need for dialysis in the first week after transplantation. Studied were risk factors for DGF in adult (age >/=16 yr) cadaveric renal transplant recipients by means of a multivariable modeling procedure. Only donor and recipient factors known before transplantation were chosen so that the probabilities of DGF could be calculated before transplantation and appropriate preventative measures taken. Data on 19,706 recipients of cadaveric allografts were obtained from the United States Renal Data System registry (1995 to 1998). Graft losses within the first 24 h after surgery were excluded from the analysis (n = 89). Patients whose DGF information was missing or unknown (n = 2820) and patients missing one or more candidate predictors (n = 2951) were also excluded. By means of a multivariable logistic regression analysis, factors contributing to DGF in the remaining 13,846 patients were identified. After validating the logistic regression model, a nomogram was developed as a tool for identifying patients at risk for DGF. The incidence of DGF was 23.7%. Sixteen independent donor or recipient risk factors were found to predict DGF. A nomogram quantifying the relative contribution of each risk factor was created. This index can be used to calculate the risk of DGF for an individual by adding the points associated with each risk factor. The nomogram provides a useful tool for developing a pretransplantation index of the likelihood of DGF occurrence. With this index in hand, better informed treatment and allocation decisions can be made.
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                Author and article information

                Journal
                Journal ID (publisher-id): AJN
                Journal ID (nlm-ta): Am J Nephrol
                Journal ID (doi): 10.1159/issn.0250-8095
                Title: American Journal of Nephrology
                Publisher: S. Karger AG
                ISSN (Print): 0250-8095
                ISSN (Electronic): 1421-9670
                Publication date Subscription-year: 2004
                Publication date (Print): August 2004
                Publication date (Electronic): 17 September 2004
                Volume: 24
                Issue: 4
                Pages: 393-401
                Affiliations
                aNephrology Service, Walter Reed Army Medical Center (WRAMC), Washington, D.C., and Uniformed Services University School of the Health Sciences, Bethesda, Md.; b Organ Transplant Service, WRAMC, Washington, D.C., and National Institutes of Health, Bethesda, Md.; cNIDDK, National Institutes of Health, and dDepartment of Preventive Medicine and Biometrics, Uniformed Services University School of the Health Sciences, Bethesda, Md., USA
                Article
                Publisher ID: 79734 Other ID: Am J Nephrol 2004;24:393–401
                DOI: 10.1159/000079734
                PubMed ID: 15256804
                SO-VID: 9be02171-fbf7-42f2-8b05-43bac58885cf
                Copyright © © 2004 S. Karger AG, Basel
                License:

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                History
                Date received : 16 April 2004
                Date accepted : 02 June 2004
                Page count
                Figures: 3, Tables: 3, References: 24, Pages: 9
                Categories
                Subject: Original Report: Patient-Oriented, Translational Research

                ScienceOpen disciplines: Cardiovascular Medicine,Nephrology
                Keywords: Sirolimus,Delayed graft function,Deceased donor kidney transplantation
                Data availability:
                ScienceOpen disciplines: Cardiovascular Medicine, Nephrology
                Keywords: Sirolimus, Delayed graft function, Deceased donor kidney transplantation

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