NCT00981838: NEMO

A Prospective, Sequential Study to Assess the Efficacy of Rituximab Therapy in Maintaining Remission of Nephrotic Syndrome After Steroid and Immunosuppressive Therapy Withdrawal in Patients With Steroid-dependant or Multirelapsing Minimal Change Disease or Focal Segmental Glomerulosclerosis (NEMO Study)

Completed Phase 3 Last updated 22 February 2013

What this trial tests

Phase 3 trial testing Rituximab in Nephrotic Syndrome in 24 participants. Completed in 1 April 2011.

Timeline

1 April 2009

Primary endpoint
1 April 2011

1 April 2011

Quick facts

Lead sponsor	Mario Negri Institute for Pharmacological Research
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	1 April 2009
Primary completion	1 April 2011
Estimated completion	1 April 2011
Sites	7 locations across Italy

Drugs / interventions tested

• Rituximab — full drug profile →

Conditions studied

• Nephrotic Syndrome — all drugs for Nephrotic Syndrome →

Sponsor

Mario Negri Institute for Pharmacological Research

Who can join

Adults 2 to 80, any sex, with Nephrotic Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Recurrence of NS.
  Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 month.

Sponsor's own description

Background. Patients, especially children, with steroid-dependent or multirelapsing nephrotic syndrome (NS) secondary to minimal change disease (MCD) or idiopathic focal and segmental glomerulosclerosis (FSGS) on continuous treatment with steroids and/or other immunosuppressive agents to limit or prevent recurrences are at increased risk of severe drug-related adverse events. Case reports suggest that Rituximab, a B cell depleting monoclonal antibody, could be a safe and effective alternative to steroid or immunosuppressants to achieve and maintain remission in this population.

Objectives. The study is primarily aimed at evaluating whether Rituximab may maintain stable NS remission after tapering and withdrawal of steroid and immunosuppressive therapy in patients with MCD or FSGS and steroid-dependent or multirelapsing NS. Secondarily, the study will assess whether Rituximab allows reducing maintenance doses of steroids and other immunosuppressants (in those who relapse), thus limiting treatment related side effects and costs.

Methods. This prospective, sequential, open, study will include 20 patients with histology evidence of MCD or FSGS and steroid-dependant or multirelapsing NS, who are on stable complete or partial remission since at least 1 month and, based on their previous history, are expected to invariably relapse after steroid/immunosuppression withdrawal. After baseline evaluation of clinical, laboratory and kidney function parameters \[including glomerular filtration rate (GFR), renal plasma flow (RPF), albumin and sodium fractional clearance and the glomerular albumin permeability assay (Palb)\], patients will receive one Rituximab infusion that will be repeated 1 week later if CD20 cells are not fully depleted from the circulation. Then ongoing immunosuppression will be progressively tapered up to complete withdrawal over 6 to 9 months. 24h proteinuria will be monitored monthly and spot urine will be tested daily by albustix to early detect disease relapses. Baseline evaluations will be repeated at study end (1 year). Relapses will be treated with high-dose steroids as per center practice and the last immunosuppressive therapy effective in preventing disease reactivation will be reintroduced.

Expected results. Rituximab is expected to prevent NS recurrence following tapering and discontinuation of steroid and other immunosuppressants. Maintaining remission without chronic immunosuppression is expected to minimize risks and costs of therapy and to remarkably improve patient outcomes.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rituximab in steroid-dependent or frequently relapsing idiopathic nephrotic syndrome.
   Ruggenenti P, Ruggiero B, Cravedi P, Vivarelli M, et al · · 2014 · cited 199× · PMID 24480824 · DOI 10.1681/asn.2013030251
2. The establishment and validation of novel therapeutic targets to retard progression of chronic kidney disease.
   Pollock C, Zuk A, Anders HJ, Ganji MR, et al · · 2017 · cited 4× · PMID 30675427 · DOI 10.1016/j.kisu.2017.07.008
3. Anti-B Cell Strategy in Nephrotic Syndrome: Beyond Rituximab.
   Jin Y, Xie Y, Fu H, Liu F, et al · · 2025 · cited 2× · PMID 41007627 · DOI 10.3390/biomedicines13092063