No benefit seen with extended prednisolone in pediatric FRNS

ATLANTA – Extending the duration of initial prednisolone treatment from 2 months to 6 months while escalating the dose failed to reduce the incidence of frequently relapsing nephrotic syndrome in children in a randomized, open-label, noninferiority trial.

The time to relapse did not differ significantly among 255 children with an initial episode of steroid-sensitive nephrotic syndrome who presented to any of 91 participating hospitals in Japan and who were randomized to receive either 2 or 6 months of initial prednisolone treatment with cumulative doses of 2,240 mg/m² and 3,885 mg/m², respectively, followed by relapse prednisolone treatment per study protocol for a total of 24 months.

At 24 months, the frequently relapsing nephrotic syndrome (FRNS)-free rates were 56.2% and 50.8% in the groups, respectively (hazard ratio, 0.86), Norishige Yoshikawa, Ph.D., reported in a late-breaking poster at Kidney Week 2013.

The hazard ratio met the prespecified noninferiority margin (HR, 1.3), said Dr. Yoshikawa of the department of pediatrics at Wakayama Medical University, Japan.

Furthermore, the groups did not differ with respect to number of relapses: 1.25 per person-year in the 2-month group vs. 1.30 per person-year in the 6-month group, for a relapse rate ratio of 0.94.

The initial approach to treatment in children with FRNS varies considerably, and these findings conflict with those of a 2007 Cochrane Review (Cochrane Database Syst. Rev. 2007;4:CD001533 [doi: 10.1002/14651858.CD001533.pub4]). That review identified 24 related trials that suggested longer duration of prednisone or prednisolone treatment (3 or more months vs. 2 months) reduced the risk of relapse at 12-24 months (risk ratio, 0.70), that there was an inverse linear relationship between treatment duration and risk of relapse (RR, 1.26), and that 6 months (vs. 3 months) of treatment was more effective for reducing the risk of relapse (RR, 0.57).

Although the Cochrane Review authors concluded that children with a first episode of steroid-sensitive nephrotic syndrome should be treated for at least 3 months – and that there appears to be an increase in benefit with up to 7 months of treatment – they also noted that additional well-designed and adequately powered randomized clinical trials were needed to assess the appropriate duration of initial steroid treatment in children with FRNS, Dr. Yoshikawa said.

The meeting was sponsored by the American Society of Nephrology. Dr. Yoshikawa’s study was supported with non–U.S. government funding. Dr. Yoshikawa reported having no disclosures.

ATLANTA – Extending the duration of initial prednisolone treatment from 2 months to 6 months while escalating the dose failed to reduce the incidence of frequently relapsing nephrotic syndrome in children in a randomized, open-label, noninferiority trial.

The time to relapse did not differ significantly among 255 children with an initial episode of steroid-sensitive nephrotic syndrome who presented to any of 91 participating hospitals in Japan and who were randomized to receive either 2 or 6 months of initial prednisolone treatment with cumulative doses of 2,240 mg/m² and 3,885 mg/m², respectively, followed by relapse prednisolone treatment per study protocol for a total of 24 months.

At 24 months, the frequently relapsing nephrotic syndrome (FRNS)-free rates were 56.2% and 50.8% in the groups, respectively (hazard ratio, 0.86), Norishige Yoshikawa, Ph.D., reported in a late-breaking poster at Kidney Week 2013.

The hazard ratio met the prespecified noninferiority margin (HR, 1.3), said Dr. Yoshikawa of the department of pediatrics at Wakayama Medical University, Japan.

Furthermore, the groups did not differ with respect to number of relapses: 1.25 per person-year in the 2-month group vs. 1.30 per person-year in the 6-month group, for a relapse rate ratio of 0.94.

The initial approach to treatment in children with FRNS varies considerably, and these findings conflict with those of a 2007 Cochrane Review (Cochrane Database Syst. Rev. 2007;4:CD001533 [doi: 10.1002/14651858.CD001533.pub4]). That review identified 24 related trials that suggested longer duration of prednisone or prednisolone treatment (3 or more months vs. 2 months) reduced the risk of relapse at 12-24 months (risk ratio, 0.70), that there was an inverse linear relationship between treatment duration and risk of relapse (RR, 1.26), and that 6 months (vs. 3 months) of treatment was more effective for reducing the risk of relapse (RR, 0.57).

Although the Cochrane Review authors concluded that children with a first episode of steroid-sensitive nephrotic syndrome should be treated for at least 3 months – and that there appears to be an increase in benefit with up to 7 months of treatment – they also noted that additional well-designed and adequately powered randomized clinical trials were needed to assess the appropriate duration of initial steroid treatment in children with FRNS, Dr. Yoshikawa said.

The meeting was sponsored by the American Society of Nephrology. Dr. Yoshikawa’s study was supported with non–U.S. government funding. Dr. Yoshikawa reported having no disclosures.

ATLANTA – Extending the duration of initial prednisolone treatment from 2 months to 6 months while escalating the dose failed to reduce the incidence of frequently relapsing nephrotic syndrome in children in a randomized, open-label, noninferiority trial.

The time to relapse did not differ significantly among 255 children with an initial episode of steroid-sensitive nephrotic syndrome who presented to any of 91 participating hospitals in Japan and who were randomized to receive either 2 or 6 months of initial prednisolone treatment with cumulative doses of 2,240 mg/m² and 3,885 mg/m², respectively, followed by relapse prednisolone treatment per study protocol for a total of 24 months.

At 24 months, the frequently relapsing nephrotic syndrome (FRNS)-free rates were 56.2% and 50.8% in the groups, respectively (hazard ratio, 0.86), Norishige Yoshikawa, Ph.D., reported in a late-breaking poster at Kidney Week 2013.

The hazard ratio met the prespecified noninferiority margin (HR, 1.3), said Dr. Yoshikawa of the department of pediatrics at Wakayama Medical University, Japan.

Furthermore, the groups did not differ with respect to number of relapses: 1.25 per person-year in the 2-month group vs. 1.30 per person-year in the 6-month group, for a relapse rate ratio of 0.94.

The initial approach to treatment in children with FRNS varies considerably, and these findings conflict with those of a 2007 Cochrane Review (Cochrane Database Syst. Rev. 2007;4:CD001533 [doi: 10.1002/14651858.CD001533.pub4]). That review identified 24 related trials that suggested longer duration of prednisone or prednisolone treatment (3 or more months vs. 2 months) reduced the risk of relapse at 12-24 months (risk ratio, 0.70), that there was an inverse linear relationship between treatment duration and risk of relapse (RR, 1.26), and that 6 months (vs. 3 months) of treatment was more effective for reducing the risk of relapse (RR, 0.57).

Although the Cochrane Review authors concluded that children with a first episode of steroid-sensitive nephrotic syndrome should be treated for at least 3 months – and that there appears to be an increase in benefit with up to 7 months of treatment – they also noted that additional well-designed and adequately powered randomized clinical trials were needed to assess the appropriate duration of initial steroid treatment in children with FRNS, Dr. Yoshikawa said.

The meeting was sponsored by the American Society of Nephrology. Dr. Yoshikawa’s study was supported with non–U.S. government funding. Dr. Yoshikawa reported having no disclosures.