Tacrolimus in steroid-resistant and steroid-dependent nephrotic syndrome. Westhoff, T. H., Schmidt, S., Zidek, W., Beige, J., & van der Giet, M. Clinical nephrology, 65(6):393--400, June, 2006.
abstract   bibtex   
BACKGROUND: Steroid resistance and steroid dependence constitute a major problem in the treatment of minimal-change disease and focal segmental glomerulosclerosis (FSGS). Cyclophosphamide and cyclosporine are well-established alternative immunomodulating agents, whereas data on FK 506 (tacrolimus) are rare. METHODS: The present work provides data from 10 patients of an open, monocentric, non-randomized, prospective trial. Five patients with steroid-dependent minimal-change nephrotic syndrome, 1 patient with steroid-refractory minimal-change disease and 4 patients with steroid-refractory FSGS were started on tacrolimus at trough levels of 5 10 microg/l. In case of steroid-dependence, prednisolone was tapered off in presence oftacrolimus within one month. RESULTS: Within 6 months, complete remission was achieved in 5 patients (50%) and partial remission in 4 patients (40%), yielding a final response rate of 90%. One patient was primarily resistent to tacrolimus (steroid-refractory minimal-change), another patient became secondarily resistant to tacrolimus after an initial remission (steroid-refractory FSGS). Average proteinuria significantly decreased by 77% from 9.5 +/- 1.4 - 2.2 +/- 1.1 g/day (p \textless 0.01). Serum protein significantly raised from 55.0 +/- 1.9 - 64.6 +/- 1.9 g/l (p \textless 0.01). Tacrolimus induced non-significant increases of blood glucose (4.9 +/- 0.1 - 5.1 +/- 0.2 mmol/l), systolic blood pressure (131.4 +/- 7.1 - 139.0 +/- 7.6 mmHg) and creatinine (93.2 +/- 13.9 103.2 +/- 15.3 mmol/l). Five patients have been tapered off tacrolimus so far, nephrotic syndrome relapsed in 4 of them (80%). Relapse occurred at tacrolimus levels between 2.6 and 6.9 ng/ml. CONCLUSIONS: Our data suggest that tacrolimus may be a promising alternative to cyclosporine both in steroid-resistant and steroid-dependent nephrotic syndrome.
@article{westhoff_tacrolimus_2006,
	title = {Tacrolimus in steroid-resistant and steroid-dependent nephrotic syndrome.},
	volume = {65},
	issn = {0301-0430 0301-0430},
	abstract = {BACKGROUND: Steroid resistance and steroid dependence constitute a major problem  in the treatment of minimal-change disease and focal segmental glomerulosclerosis (FSGS). Cyclophosphamide and cyclosporine are well-established alternative immunomodulating agents, whereas data on FK 506 (tacrolimus) are rare. METHODS: The present work provides data from 10 patients of an open, monocentric, non-randomized, prospective trial. Five patients with steroid-dependent minimal-change nephrotic syndrome, 1 patient with steroid-refractory minimal-change disease and 4 patients with steroid-refractory FSGS were started on tacrolimus at trough levels of 5 10 microg/l. In case of steroid-dependence, prednisolone was tapered off in presence oftacrolimus within one month. RESULTS:  Within 6 months, complete remission was achieved in 5 patients (50\%) and partial  remission in 4 patients (40\%), yielding a final response rate of 90\%. One patient was primarily resistent to tacrolimus (steroid-refractory minimal-change), another patient became secondarily resistant to tacrolimus after an initial remission (steroid-refractory FSGS). Average proteinuria significantly decreased  by 77\% from 9.5 +/- 1.4 - 2.2 +/- 1.1 g/day (p {\textless} 0.01). Serum protein significantly raised from 55.0 +/- 1.9 - 64.6 +/- 1.9 g/l (p {\textless} 0.01). Tacrolimus  induced non-significant increases of blood glucose (4.9 +/- 0.1 - 5.1 +/- 0.2 mmol/l), systolic blood pressure (131.4 +/- 7.1 - 139.0 +/- 7.6 mmHg) and creatinine (93.2 +/- 13.9 103.2 +/- 15.3 mmol/l). Five patients have been tapered off tacrolimus so far, nephrotic syndrome relapsed in 4 of them (80\%). Relapse occurred at tacrolimus levels between 2.6 and 6.9 ng/ml. CONCLUSIONS: Our data suggest that tacrolimus may be a promising alternative to cyclosporine both in steroid-resistant and steroid-dependent nephrotic syndrome.},
	language = {eng},
	number = {6},
	journal = {Clinical nephrology},
	author = {Westhoff, T. H. and Schmidt, S. and Zidek, W. and Beige, J. and van der Giet, M.},
	month = jun,
	year = {2006},
	pmid = {16792133},
	keywords = {Adult, Blood Glucose/analysis, Blood Pressure/drug effects, Blood Proteins/analysis, Creatinine/urine, Drug Resistance, Drug Therapy, Combination, Female, Glomerulosclerosis, Focal Segmental/drug therapy, Humans, Male, Middle Aged, Nephrosis, Lipoid/drug therapy, Nephrotic Syndrome/*drug therapy, Prednisolone/therapeutic use, Proteinuria/drug therapy, Steroids/pharmacology/*therapeutic use, Tacrolimus/*therapeutic use},
	pages = {393--400}
}

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