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Kidney Week

Abstract: SA-PO908

Intravenous Rituximab vs. Oral Mycophenolate Mofetil in Sustaining Remission in Calcineurin Inhibitor-Dependent Steroid-Resistant Nephrotic Syndrome: An Open-Label Randomized Controlled Trial

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Sinha, Aditi, All India Institute of Medical Sciences, New Delhi, Delhi, India
  • Bagga, Arvind, All India Institute of Medical Sciences, New Delhi, Delhi, India

Group or Team Name

  • Division of Nephrology, Dept of Pediatrics; Nephrotic Syndrome Study Group.
Background

Retrospective unicenter studies in patients with steroid-resistant nephrotic syndrome (NS) show that switching of calcineurin inhibitors (CNI) to oral mycophenolate mofetil (MMF) or IV rituximab enables remission and is corticosteroid-and CNI-sparing, while avoiding therapy-associated adverse effects (AE). However, prospective controlled studies are lacking.

Methods

This open-label multicenter RCT will examine the superiority of IV rituximab versus oral MMF in maintaining satisfactory remission in patients with steroid-resistant NS who were in complete or partial remission while on therapy with tacrolimus or cyclosporine for over 2-yrs, but continued to show steroid-sensitive relapses. Eligible consenting patients with steroid-resistant NS, 1-18 yr-old, with complete or partial remission and steroid sensitive relapses while on ≥2-yr therapy with CNI, will be randomized to switch therapy to either oral MMF for 1-yr or IV rituximab (2 doses a week apart; 1 dose 6-months later). The primary outcome, on intention-to-treat analysis, will be the proportion of patients with satisfactory remission (sustained remission or infrequent relapses) at 1-yr (Fig. 1). Secondary outcomes are the proportions of patients with frequent relapses, steroid resistance & serious AE, incidence of relapses, prednisolone exposure, and changes in anthropometry & biochemistry (CTRI/2022/10/046890).

Results

The study began enrolment in October 2022 and will close enrolment in February 2025.

Conclusion

Findings from the study shall have important implications for guiding the choice of non-nephrotoxic therapies following induction and maintenance of remission with CNI for childhood idiopathic steroid-resistant NS.

Funding

  • Government Support – Non-U.S.