Effectiveness of combination Prednisone–Tacrolimus compared with Prednisone –Cyclosporine in treatment Steroid-Resistant Nephrotic Syndrome Dra. Irma Esther.

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Effectiveness of combination Prednisone–Tacrolimus compared with Prednisone –Cyclosporine in treatment Steroid-Resistant Nephrotic Syndrome Dra. Irma Esther del Moral Espinosa Nefrología Pediátrica Hospital Infantil de México Federico Gómez drairma.nefroped@gmail.com

INTRODUCTION Many children with idiopathic nephrotic syndrome initially respond to steroid therapy, but patients with frecuent relapses,steroid dependency or resistance to steroid therapy require alternative treatment.

INTRODUCTION Cyclosporine A is usually effective. Tacrolimus reduce side effects.

INTRODUCTION Most children with idiopathic nephrotic syndrome(NS) usually show in the renal biopsy minimal change disease (MCD) and responding to treatment with steroids. However, 5% present steroid-resistant nephrotic syndrome(SRNS) with the presence of focal segmental glomerulosclerosis (FSGS).

OBJECTIVE Demonstrate treatment with Prednisone (PDN) and Tacrolimus (FK) in pediatric patients with SRNS for a period of 12 months having greater frequency of complete or partial remissions in relation to the standard treatment with prednisone and Cyclosporine (CyA).

MATERIAL AND METHODS Comparative, multicenter randomized clinical trial was conducted in children with SRNS, approved by Investigation and Ethics Committees. Both groups received PDN 60mg/m2/day, during 1 month continued by 30mg/m2/day each/48h. for 5 months. Inclusion criteria: SRNS, normal GFR, treatment previous PDN only.

MATERIAL AND METHODS Group I receive CyA 5mg/kg/day in two doses for 12 month. Through levels 100-200 ng/ml. Group II receive FK 0.10mg/Kg/day in two doses for 12 months. Through levels 5-10 ng/ml. Renal biopsy at beginning of treatment and control at 12 months. Cholesterol, albumin and serum creatinine, glomerular filtration rate, proteinuria were determinated in both groups

MATERIAL AND METHODS Group II receive FK 0.10mg/Kg/day in two doses for 12 months. Through levels 5-10 ng/ml. Renal biopsy at beginning of treatment and control at 12 months. Cholesterol, albumin and serum creatinine, glomerular filtration rate, proteinuria were determinated in both groups

MATERIAL AND METHODS Complete remission: disappearance of clinical symptoms and negative test for urine protein. Partial remission: reduce of proteinuria 4.1- 40mgm2BSA No response: without clinical improvement within 6 months of therapeutic levels of CyA and FK.

BIOPSY DIAGNOSIS

RESULTS Results: 20 patients were included, 10 in Group I and 10 in Group II with follow-up of 8 years. 9 and 7 .

RESULTS Demographic characteristics CyA Group I FK Group II p value Age of onset 7.46 + 4.5 8.3+4.8 0.62 Gender male/female 6/3 3/ 4 0.68 24 h urinary protein excretion(g) 3.71 + 1.64 4.85 + 2.57 0.007 Serum cholesterol mg/dl 345+ 98 386+ 110 0.16 Serum triglycerides mg/dl 398+ 104 376+ 102 Serum creatinine mg/dl 0.45 + 0.23 0.48+ 0.28 0.39 eGFR Schwartz ml/min 128+ 46 138 + 34 0.52

RESULTS Time of treatment Answer in weeks Remision type PDN y CyA Group I PDN y FK Group II 2 Complete 14.2 (1/9) 28.5 (2/7) 12 28.5 (2/9) 42.85 (3/7) 20 14.28 (1/7) 36-52 0 (0/7) Parcial 0 (0/7) No response 14.28 (1/7) 55.5 % 85.7 %

RESULTS Secondary hypertension was present in 71.42% (6/9) for group I and 25% (2/7) for group II. Relapses PDN/FK (4/7) PDN/CyA (5/9) 24 months (+8 months) 22.8 months (+12)

BIOPSY AFTER ONE YEAR OF TX

10 YEARs later Demographic characteristics CyA FK p valeu Age of onset 16.46 + 4.5 15.3+4.8 0.62 Gender male/female 6/3 3/ 4 0.68 24 h urinary protein excretion(g) 1.71 + 1.64 2.85 + 2.57 0.007 Serum cholesterol mg/dl 205+ 68 126+ 110 0.16 Serum triglycerides mg/dl 194+ 64 206 + 61 Serum creatinine mg/dl 0.68 + 0.23 0.69+ 0.28 0.39 eGFR Schwartz ml/min 128+ 46 138 + 34 0.52

CONCLUSION In pediatric patients with SRNS, the treatment FK-PDN had a greater percentage of complete remission than CyA-PDN treatment and lower incidence of hypertension and nephrotoxicity.

Aknowledgments Dr. Luis Velázquez Jones. Jefe de Departamento Dr. Saúl Valverde Rosas. Departamento de Nefrología Dr. Benjamín Romero Navarro. Departamento de Nefrología. Hospital Español Dra. Rebeca Gómez Chico. Departamento de Nefrología Dra. Mara Medeiros Domingo. Departamento de Nefrología Quim. Ana María Hernández. Departamento de Nefrología Dr. Guillermo Ramon. Departamento de Patología Dr. José Carlos Romo Vázquez. Departamento de Nefrología Dr. Ricardo Guerrero Kanán . Departamento de Nefrología