Evaluating efficacy and safety of two immunosuppressive regimens in kidney transplant patients

The follow up has not documented beneficial effect of daclizumab use to the existing standard regimen. Immunosuppression with tacrolimus in combination with mycophenolate mophetil and corticosteroids is already very efficient regimen and from the long-term perspective brings very good survival and transplanted kidney function results and benefits transplant patients.

Milan Kuman M.D., P Studeník M.D., V.Mejzlík M.D., J.Ondrášek M.D., P.Němec M.D.,PhD.

TITLE: Evaluating the efficacy and safety of daclizumab, tacrolimus , mycophenolate and corticosteroids immunosuppressive regimen in comparison to current standart immunosuppression (tacrolimus , mycophenolate and corticosteroids) in renal transplantation.

END POINTS: PRIMARY: to determine the biopsy-confirmed acute rejection rate at month 12. SECONDARY: to determine the renal function, as expressed by serum creatinin and the glomerular filtration rate ( assessed by creatinine clearence ) over the course of study and at month 12. To determine patient and graft survival rates at mont 12.

STUDY DESIGN:- group A – daclizumab, tacrolimus , mycophenolate and corticosteroids group group B- control group tacrolimus , mycophenolate and corticosteroids group -NUMBER OF PATIENTS:40 patients, 20 for each treatment arm. Patients meeting all the selection kriteria were randomized prior to transplantation in l : l ratio to one of the two treatment arms of the study.

MAIN SELECTION CRITERIA:-INCLUSION CRITERIA male or female patiens between 18-70 years. Recipients of single-organ renal primary allograft or second renal transplant ( provided that the previous graft was not lost from acute rejection) from live or deseased donor. -EXCLUSION CRITERIA PRA › 20%, in the 6 months period prior to enrollment, cold ischemia time ›30 hours, previous treatment with daclizumab, history of malignancy in two last years, chronic infection.

TREATMENT PERIOD: the first dose of daclizumab was administred within 4 hours pre transplant in arm A. The first dose of mycophenolate mofetil and tacrolimus was administred within 6 hours pre-transplant. The duration of treatment was 12 months.

RESULTS: acute rejection rate at 12 months- group A one corticosensitive rejection,-group B two corticosensitive rejections – statistically not signifiant. Serum creatinin at month l was: group A 142±44,2 umol/l group B 154±42,7 umol/l and at month 12 group A 133,4±32,2 umol/l , group B148,9 ±44,3 umol/l (statistically not significant). Glomerular filtration at month l was : group A 1,058±0,385 ml/s group B 0,95 ±0,280 ml/s and at month 12 group A 1,136±0,389 ml/s group B 1,099±0,256 ml/s (statistically not significant). Patient survival rates at 12 months were 100% in both groups. Graft survival rates at 12 months was : group A 95% , group B 100% (statistically not significant).

CONCLUSION: The follow up has not documented beneficial effect of daclizumab use to the existing standard regimen. Immunosuppression with tacrolimus in combination with mycophenolate mophetil and corticosteroids is already very efficient regimen and from the long-term perspective brings very good survival and transplanted kidney function results and benefits transplant patients.

Milan Kuman M.D. Transplant unit Tel.:+ 420-5-4318 2544 Fax: +420-5-4318 2541 Mob:+420-723 024 466
E-mail: milankuman@cktch.cz

Klíčová slova: CellCept; transplantace

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