Should mycophenolate mofetil be administered prior to cyclosporine A as a steroid-sparing agent to children with steroid-dependent nephrotic syndrome?

2018 ◽  
Vol 33 (12) ◽  
pp. 2389-2390 ◽  
Author(s):  
Shuichiro Fujinaga ◽  
Koji Sakuraya
Keyword(s):  
Nephrotic Syndrome ◽  
Mycophenolate Mofetil ◽  
Cyclosporine A ◽  
Steroid Dependent ◽  
Steroid Sparing ◽  
Steroid Dependent Nephrotic Syndrome

scholarly journals Randomized clinical trial to compare efficacy and safety of repeated courses of rituximab to single-course rituximab followed by maintenance mycophenolate-mofetil in children with steroid dependent nephrotic syndrome

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Biswanath Basu ◽  
Stella Preussler ◽  
Anja Sander ◽  
T. K. S. Mahapatra ◽  
Franz Schaefer
Keyword(s):  
Nephrotic Syndrome ◽  
Mycophenolate Mofetil ◽  
B Cell ◽  
Phase Iii ◽  
Long Term Results ◽  
Link Type ◽  
Steroid Dependent ◽  
Frequent Relapses ◽  
Steroid Sparing ◽  
Steroid Dependent Nephrotic Syndrome

Abstract Background Approximately 30% of children with idiopathic nephrotic syndrome develop a complicated course with frequent relapses or steroid dependency. Rituximab, a B cell depleting monoclonal antibody, is a safe and effective alternative to steroids or other immunosuppressants for achieving and maintaining remission in this population at short term. Despite the good initial response relapses inevitably occur after regeneration of B lymphocytes, necessitating either repeat courses of rituximab or addition of another steroid-sparing immunosuppressant. Methods This is a prospective, single-center, open-label, two-parallel-arm randomized controlled phase III study among children with steroid dependent nephrotic syndrome who are maintained in remission with oral steroids. One hundred children will be randomized to either Rituximab and maintenance Mycophenolate mofetil (A) or repeated courses of prophylactic Rituximab only (B). In arm A, mycophenolate mofetil (1200 mg/m2 per day) will be started 3 months after Rituximab administration. In arm B, Rituximab infusions will be administered at 0, 8 and 16 months if B cell count normalize at the given time points. Prednisolone will be discontinued in both groups 2 weeks following first course of rituximab. Primary aim is to evaluate the difference in 24-month relapse-free survival. Main secondary endpoints are cumulative prednisolone dose, frequency of relapses and changes in anthropometry. Circulating B lymphocyte populations will be studied as biomarkers or predictors of rituximab responsiveness and adverse events will be analysed. Discussion The study will provide evidence as to the comparative safety and efficacy of two alternative steroid-sparing therapeutic options in children suffering from steroid dependent nephrotic syndrome. The two-year study design will address the long-term results obtained with the alternative treatment protocols. Trial registration This trial was prospectively registered to the Clinicaltrial.gov (NCT03899103 dated 02/04/2019; https://clinicaltrials.gov/) and Clinical Trials Registry of India (CTRI/2019/04/018517 dated 09/04/2019).

Mycophenolate Mofetil after Rituximab for Childhood-onset Complicated Frequently-relapsing or Steroid-dependent Nephrotic Syndrome

2021 ◽  
pp. ASN.2021050643
Author(s):  
Kazumoto Iijima ◽  
Mayumi Sako ◽  
Mari Oba ◽  
Seiji Tanaka ◽  
Riku Hamada ◽  
...  
Keyword(s):  
Nephrotic Syndrome ◽  
Mycophenolate Mofetil ◽  
Treatment Failure ◽  
Treatment Period ◽  
Immunosuppressive Agents ◽  
Steroid Resistance ◽  
Rank Test ◽  
Childhood Onset ◽  
Steroid Dependent ◽  
Steroid Dependent Nephrotic Syndrome

Background. Rituximab is the standard therapy for childhood-onset complicated frequently-relapsing or steroid-dependent nephrotic syndrome (FRNS/SDNS). However, most patients redevelop FRNS/SDNS following peripheral B cell recovery. Methods. We conducted a multicenter, randomized, double-blind, placebo-controlled trial to examine whether mycophenolate mofetil (MMF) administration after rituximab can prevent treatment failure (FRNS, SDNS, steroid resistance, or use of immunosuppressive agents or rituximab). Thirty-nine patients (per group) were treated with rituximab, followed by either MMF or placebo until Day 505 (treatment period). The primary outcome was time to treatment failure (TTF) throughout the treatment and follow-up periods (until Day 505 for the last enrolled patient). Results. TTFs were clinically but not statistically significantly longer among patients given MMF after rituximab than among patients receiving rituximab monotherapy (median: 784.0 vs. 472.5 days, hazard ratio (HR): 0.593, 95% confidence interval (CI): 0.336-1.049, log-rank test: P=0.0694). Because most patients in the MMF group presented with treatment failure after MMF discontinuation, we performed a post-hoc analysis limited to the treatment period and found that MMF after rituximab prolonged the TTF and decreased the risk of treatment failure by 80% (HR: 0.202, 95% CI: 0.081-0.503). Moreover, MMF after rituximab reduced the relapse rate and daily steroid dose during the treatment period by 74% and 57%, respectively. The frequency and severity of adverse events were similar in both groups. Conclusions. Administration of MMF after rituximab may sufficiently prevent the development of treatment failure and is well tolerated, although the relapse-preventing effect disappears after MMF discontinuation.

Clinical evaluation of chronic nephrotoxicity of long-term cyclosporine A treatment in adult patients with steroid-dependent nephrotic syndrome

Nephrology ◽  
2011 ◽  
Vol 16 (3) ◽  
pp. 319-325 ◽  
Author(s):  
TOMONARI OKADA ◽  
HIROSHI MATSUMOTO ◽  
YUME NAGAOKA ◽  
RYO TOMARU ◽  
HIDEAKI IWASAWA ◽  
...  
Keyword(s):  
Nephrotic Syndrome ◽  
Clinical Evaluation ◽  
Cyclosporine A ◽  
Adult Patients ◽  
Steroid Dependent ◽  
Steroid Dependent Nephrotic Syndrome

Steroid sparing effect of a herbal preparation in steroid-dependent nephrotic syndrome

2006 ◽  
Vol 21 (7) ◽  
pp. 1031-1033 ◽  
Author(s):  
Arpana Iyengar ◽  
Hrishikesh Damle ◽  
Chanda Kulkarni ◽  
Latha Damle ◽  
Kishore Phadke
Keyword(s):  
Nephrotic Syndrome ◽  
Herbal Preparation ◽  
Steroid Dependent ◽  
Sparing Effect ◽  
Steroid Sparing ◽  
Steroid Dependent Nephrotic Syndrome

scholarly journals The safety and efficacy of mycophenolate mofetil in children and adolescents with steroid-dependent nephrotic syndrome: a single-centre study

2019 ◽  
Vol 13 (2) ◽  
pp. 179-183
Author(s):  
Saravanakumar Karunamoorthy ◽  
Dineshkumar Thanigachalam ◽  
Dhanapriya Jeyachandran ◽  
Sakthirajan Ramanathan ◽  
Gopalakrishnan Natarajan ◽  
...  
Keyword(s):  
Nephrotic Syndrome ◽  
Mycophenolate Mofetil ◽  
Median Duration ◽  
Significant Risk ◽  
Duration Of Treatment ◽  
Minimum Period ◽  
Steroid Dependent ◽  
Long Term Treatment ◽  
Steroid Dependent Nephrotic Syndrome

Abstract Background Steroid-dependent nephrotic syndrome (SDNS) patients experience frequent relapse or adverse effects on long-term treatment with steroids or cyclophosphamide. This study assessed the efficacy and side effect profile of mycophenolate mofetil (MMF) therapy in children with nephrotic syndrome in our population. Methods A retrospective study was performed on children with SDNS who were on MMF therapy for a minimum period of 1 year, and were on regular follow-up in the Department of Nephrology at the Institute of Child Health and hospital for children attached to Madras Medical College. Results The study included 87 patients, with a male:female ratio of 2:1. The median age at diagnosis of nephrotic syndrome was 3 years [95% confidence interval (CI): 1–8 years], which was found to be a statistically significant risk factor for MMF failure. The median duration of follow-up after initiation of MMF therapy was 3 years and 3 months (95% CI: 1 year and 3 months to 6 years and 6 months). At initial evaluation, 31 (36%) patients presented with SDNS while the remaining had frequently relapsing nephrotic syndrome progressing to SDNS. Intravenous cyclophosphamide was used as first-line therapy in 82 patients, of whom 24 patients had persistent proteinuria while the remaining 58 had attained remission for a median duration of 6 months. The median duration of treatment with MMF was 2 years and 6 months (95% CI: 1 year and 3 months to 4 years and 6 months). MMF was used at a mean dose of 28.5 mg/kg. Seventy-two (83%) patients were MMF-sensitive, and these patients had a reduction in mean prednisolone dose from 1.28 to 0.35 mg/kg (P < 0.05). Among the MMF-sensitive patients, 31 had stopped MMF after a minimum period of 2 years, following which they had a median remission period of 5 months (95% CI: 1–8 months). MMF failure occurred in 15 (17%) patients. Adverse events were documented in 19 (22%) patients. Conclusions Continuous MMF therapy achieved remission in 83% of patients. MMF was well tolerated in the study population and discontinuation of MMF resulted in 100% relapse.

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