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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-006750-17-IT
Enrollment
20
Registered
2009-01-27
Start date
2009-04-14
Completion date
Unknown
Last updated
2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrotic Syndrome secondary to minimal change disease (MCD) or idiopathic focal and segmental glomerulosclerosis (FSGS. MedDRA version: 9.1 Level: LLT Classification code 10029171 MedDRA version: 9.1 Level: LLT Classification code 10058326 MedDRA version: 9.1 Level: LLT Classification code 10016832

Interventions

Trade Name: MABTHERA Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab Concentration unit: mg milligram(s)

Sponsors

IST. DI RICERCHE FARMACOLOG. M. NEGRI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Males and females > 10 years - Steroid-dependent or multirelapsing NS (defined on the basis of the occurrence of more than 2 relapses in the previous year in spite of steroid and/or other immunosuppressive therapy). Only patients reported to invariably relapse upon treatment tapering or withdrawal who are on stable (from at least 1 month) complete (=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Advanced renal failure (creatinine clearance less than 20 ml/min/1.73m2); - Evidence of B or C virus infection; - Refractory or persistent NS; - Genetic mutations associated with intrinsic abnormalities of the glomerular barrier that would hardly be affected by rituximab treatment; - Pregnancy or lactating; - Women of childbearing potential without following a scientifically accepted form of contraception; - Legal incapacity; - Evidence of an uncooperative attitude; - Previous diagnosis of: intellectual disability/mental retardation, dementia, schizophrenia. - Any evidence that patient will not be able to complete the trial follow-up.

Design outcomes

Primary

MeasureTime frame
Main Objective: 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.;Secondary Objective: Secondarily, the study will assess whether Rituximab allow reducing maintenance doses of steroids and other immunosuppressants (in those who relapse), thus limiting treatment related side effects and costs.;Primary end point(s): Recurrence of NS.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026