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Kidney Week

Abstract: FR-PO0820

Use of Rituximab in the Treatment of Nephrotic Glomerulonephritis (TURING): Effect of Achieved Remission Status on the Risk of Relapse

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

  • Griffith, Megan, Imperial College Healthcare NHS Trust, London, England, United Kingdom
  • Qian, Wendi, Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Trust, Cambridge, England, United Kingdom
  • Geddes, Colin C., NHS Greater Glasgow and Clyde, Glasgow Renal and Transplant Unit, Glasgow, Scotland, United Kingdom
  • Jayne, David R.W., University of Cambridge, Biomedical Campus, Cambridge, England, United Kingdom
  • Kronbichler, Andreas, Department of Internal Medicine IV, Medical University Innsbruck, Innsbruck, Austria
  • Willcocks, Lisa, Cambridge University Hospital NHS Trust, Cambridge, England, United Kingdom

Group or Team Name

  • On Behalf of the TURING Investigator Group
Background

Minimal change disease (MCD) and focal segmental glomerulosclerosis (FSGS) are the commonest cause of primary nephrotic syndrome (NS) in adults. Achieving and maintaining remission is important for renal survival, with complete remission (CR) conferring a better prognosis than partial remission (PR). TURING was a randomised, double-blind, placebo-controlled trial of rituximab in patients with MCD/FSGS. It demonstrated rituximab was highly effective in maintaining remission. In addition more patients with FSGS treated with rituximab achieved CR compared to placebo. Here, we investigate the impact of rituximab treatment on patients who achieved CR vs PR alone in TURING, on the subsequent relapse rates.

Methods

149 adults at presentation with NS secondary to MCD/FSGS, from 23 UK sites were randomised to receive rituximab (1g) or placebo, at study entry, 2 weeks and 6 months. Patients not in remission by week 16 were withdrawn; otherwise, patients continued in the trial until relapse. The primary endpoint was time from remission to relapse. Patients randomised to placebo, who relapsed, were invited to enrol in the Open Label Phase (OLP) to receive rituximab as for the main trial rituximab group.

Results

122 (59 placebo, 63 rituximab) patients achieved remission (71 CR, 51 PR) by week 16. 80 patients had MCD and 42 FSGS. With a median follow up of 2.8 years, 67 patients relapsed. Kaplan-Meier estimates of time to relapse showed significant benefit from rituximab for CR and PR subgroups, respectively, the hazard ratio (HR) =0.14, 95%CI=0.06-0.30, p<0.0001 for CR patients and HR=0.40, 95%CI=0.19-0.86, p=0.018 for PR. There was an indication of greater efficacy in CR patients (interaction p=0.061). All 41 OLP patients achieved remission (25 CR, 16 PR); there were 13 relapses at a median follow up of 2.1 years. As in the main trial, patients in CR maintained remission for longer than those only achieving PR.

Conclusion

Rituximab is effective in maintaining remission from NS in adults with MCD and FSGS with a greater efficacy for patients who achieve CR than PR.

Funding

  • Government Support – Non-U.S.