Unregistered User If this is not your name, click here.
		Contact Us | Order Now | Journals | Bookstore | Register a colleague
	Select a ChannelAcneAIDS and HIVAllergy OtherAlzheimer'sAnaesthesiology OtherAngina Pectoris/MIAnxietyArthritis OtherAsthmaBack PainBacterial InfectionsBladder CancerBone Marrow TransplantationBreast CancerCardiology OtherCataractCell TransplantationCervical CancerCholesterol/Lipid disordersCirrhosisClinical PharmacologyColorectal CancerCongestive Heart FailureContact DermatitisContraceptionCOPDCystic FibrosisDental and Oral DisordersDepressionDermatology OtherDiabetesDialysisEating DisordersElbowEmergency MedicineEndocrinology OtherEpilepsyErectile DysfunctionFibromyalgiaGastro OtherGeneticsGenitourinary OtherGeriatricsGERD/GastritisGlaucomaH. Pylori/UlcerHaematology OtherHair LossHeadachesHepa/Biliary OtherHepatitisHipHRTHypertensionIBDImmunologyInfectious OtherInfertilityIntensive CareIrritable Bowel SyndromeKneeLeukemiasLiver CancerLung CancerLupusLymphomasMelanomaMenopauseMultiple Sclerosis Nephrology OtherNeurologic OtherNutritional / Metabolic OtherOb/Gyn OtherObesityOncology OtherOphth. OtherOphthalmic SurgeryOrgan TransplantationOrthopaedics OtherOsteoarthritisOsteoporosisOtitisOtorhino. OtherOvarian CancerPaediatricsPainPancreatic CancerParkinson'sPregnancyProstate CancerPsychiatry OtherPulmonary OtherRadiologyRenal CancerRenal FailureRespiratory InfectionsRheumatoid arthritisRheumatology OtherRhinitisSchizophreniaShoulderSleep ApnoeaSleep DisordersSpineStrokeSTDsSurgeryThyroid DisordersTransfusionTransplant Surgery OtherTraumaUrinary IncontinenceUrinary tract infectionsVaccinologyVascular DisordersViral Infections

SEARCH   News Bookstore Medline The Web Meetings & Congresses Complete Doctor's Guide    EXPLORE :    All News   All Webcasts   All Cases   All Meetings & Congresses   All Medical Resources New drugs / indications English Dictionary Medical Dictionary Thesaurus Warning | Privacy | Awards  Favourite Journals  Click here to choose your favourite journals  Favourite Sites  Click here to choose your favourite sites  Languages  Select languageEnglishFrançais

Immunosuppressive Combination Effective In Over Half Of Kidney Transplants MOUNTAIN VIEW, CA -- May 13, 1998 -- Data from phase II clinical trials of a new immunosuppressive combination that shows positive results for kidney transplantation were presented at the joint plenary session of the American Society of Transplant Physicians and American Society of Transplant Surgeons annual meeting in Chicago. The trial is designed to evaluate the combined use of Hoffman-La Roche Inc.’s Zenapax(R) (daclizumab), Roche's CellCept(R) (mycophenolate mofetil) and corticosteroids, without commonly used calcineurin inhibitors such as cyclosporine or tacrolimus, in kidney transplant patients. Interim data (150 day median follow-up) show that: -- 58 percent (57 of 98) of evaluable patients who received successful kidney transplants remained rejection episode-free without the addition of a potentially nephrotoxic calcineurin inhibitor; -- 80 percent (33 of 41) of first acute rejection episodes were successfully treated with corticosteroid therapy, although most of these patients later received a calcineurin inhibitor, principally tacrolimus; -- Median serum creatinine levels (a measure of kidney function) were improved in patients who did not receive calcineurin inhibitors as compared to those receiving such drugs in a Phase III Zenapax trial; -- There were no grafts lost due to rejection episodes. Patient survival was 100 percent and graft survival 99 percent (97 of 98); -- There were no unanticipated adverse events. Calcineurin inhibitors such as cyclosporine have revolutionised the field of transplantation, enabling a dramatic improvement in the short-term survival of transplanted organs. However, it is well-documented that administration of calcineurin inhibitors can lead to renal toxicity (as evidenced by an increase in serum creatinine levels) -- a serious condition that can ultimately result in loss of the transplanted kidney. "We are looking for an immunosuppressive regimen that significantly reduces the rate of rejection without causing serious side effects, to improve a patient's long-term chances of sustaining a transplanted organ," said Flavio Vincenti, M.D., professor of clinical medicine at the University of California, San Francisco, who presented the trial data today. "While further evaluation is still needed, the study results complement the findings from our Phase III Zenapax study and open the door for other possible trial designs that will allow for optimal prevention of acute rejection with decreased use of more toxic drugs." The Phase II trial is a multicentre, international, open-label, single-arm study involving 100 kidney transplant patients, 98 of whom are evaluable. Patients received five doses of Zenapax, with the first 2.0 mg/kg dose given pre-transplant and the subsequent four 1.0 mg/kg doses given at two week intervals. The dose of CellCept is 3 grams/day for the first six months and 2 grams/day thereafter. The objectives of the study are to evaluate acute rejection at 6 months, determine the proportion of patients needing calcineurin inhibitors and evaluate safety. There can be no assurance that preliminary results from this trial will be representative of the results as the trial proceeds to completion and final analysis. Zenapax, approved and launched in the U.S. in December 1997 and in Switzerland in March 1998, is the first, and to date only, humanised monoclonal antibody to be approved by the U.S. Food and Drug Administration. E-mail this page to a friend or colleague! To print, use this version