BERKELEY, CA (UroToday.com) - A study by Gulati, et al evaluated the safety and efficacy of tacrolimus (TAC) in children with steroid-resistant nephrotic syndrome. The group had 22 consecutive patients who were study prospectively. Tacrolimus was initiated with a dose of 0.10 mg/kg/day and titrated to attain adequate trough levels. All these patients were treated with a concomitant prednisone which was subsequently tapered off and completely stopped. Successful outcomes were those attained a complete remission or partial remission.

The mean age of onset was 7.33 ± 5.9. There were 20 boys and 2 girls. Of the 22 children, 9 had minimal change disease, 11 had focal segmental glomerulosclerosis and the other 2 had diffuse mesangial hypercellularity on histopathology. Tacrolimus had to be withdrawn in 3 children because of its side effects. The remaining 19 children who received the therapy were able to achieve target levels. Complete resolution was seen in 16 (84%) children. Of the remaining 3 children, 2 (10.5%) attained a partial response and 1 was completely nonresponsive. The mean time to achieve the remission was 63.2 ± 44 days. The mean urine spot protein/creatinine ratios were significantly lower and the mean serum albumin levels were significantly higher when they compared those levels prior to starting the tacrolimus. The GFR's did not change between pre and post treatment. Their mean follow up was 290 days with a range of 164-416 days. This, by far, is the largest study on the safety and efficacy of tacrolimus on steroid-resistant nephrotic syndrome. The groups results suggests that tacrolimus is not only effective but also well tolerated in these patients.

Reference: Sanjeev Gulati, Narayan Prasad, Raj K. Sharma, Alok Kumar, Amit Gupta and Vinod P. Baburaj

Nephrol Dial Transplant. 2008 Mar;23(3):910-3
doi: 10.1093/ndt/gfm688

PubMed Abstract
PMID: 18039644

UroToday.com Pediatric Urology Section

Written by Pasquale Casale, MD, a Contributing Editor with UroToday.

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