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
- Glomerular Diseases: Therapeutics
November 04, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
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.