Rituximab for Idiopathic Nephrotic Syndrome

Conditions

• Idiopathic Nephrotic Syndrome

Eligibility Criteria

Sex

ALL

Age

1 Year - 16 Years

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG

Study Details

Open-label, randomized, controlled trial due to value whether the monoclonal antibody rituximab is non-inferior to steroids in maintaining remission in juvenile forms of SDNS. The investigators will enroll 30 pediatric patients affected by idiopathic nephrotic syndrome, who have been in treatment with steroids for at least one year. The lowest dose of drug required to maintain a stable remission will be between 0.4 and 0.7 mg/ kg/ day. This trial provides an initial run-in phase of one month during wich remission will be achieved by means of a standard oral prednisone course. Once remission has been achieved children will be randomized in a parallel arm open label RCT to continue prednisone alone for one month (control) or to add a single intravenous infusion of rituximab (375 mg/m2 - intervention). Prednisone will be tapered in both arms after one month.

Key Dates

Start date

Jul 31, 2013

Status verified

Jan 2023

Primary completion

Dec 31, 2016

Completion

Dec 31, 2016

Study Design

Enrollment

30 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Steroid tapering.
• Experimental: Rituximab
  Single administration of Rituximab 375 mg/mq at a rate of 0.5 to 1.5 ml/min over approximately 6 hours, following the infusion of 2.5-5 mg of intravenous chlorfenamine maleate (based on the local protocol and patient tolerance), methylprednisolone (2 mg/Kg) in normal saline and oral paracetamol (8 mg/kg).

Primary Outcome Measure

Three months proteinuria [ Time Frame: 3 months ]