NCT04402580

Efficacy of Anti-CD20 Antibodies (Rituximab Biosimilar) in the Treatment of Childhood Steroid-dependent Nephrotic Syndrome

Terminated Phase 2 Last updated 14 September 2020

What this trial tests

Phase 2 trial testing Rituximab Biosimilar in Nephrotic Syndrome Steroid-Dependent in 30 participants. Terminated before completion.

Timeline

1 July 2019

Primary endpoint
31 August 2020

31 August 2020

Quick facts

Lead sponsor	Istituto Giannina Gaslini
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 July 2019
Primary completion	31 August 2020
Estimated completion	31 August 2020
Sites	1 location across Italy

Drugs / interventions tested

• Rituximab Biosimilar — full drug profile →
• Mycophenolate Mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →

Conditions studied

• Nephrotic Syndrome Steroid-Dependent — all drugs for Nephrotic Syndrome Steroid-Dependent →

Sponsor

Istituto Giannina Gaslini — full company profile →

Who can join

Adults 3 to 24, any sex, with Nephrotic Syndrome Steroid-Dependent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Anti-CD20 monoclonal antibodies are emerging as the steroid-sparing therapy of choice for nephrotic syndrome.

This Randomized Clinical Trial seeks to evaluate whether Rituximab biosimilar maintains drug-free disease remission in patientswith steroid-dependent nephrotic syndrome for 12-24 months and verify its superiority vs. mycophenolate mofetil, the reference standard therapy. The investigators will compare the risk of relapse to test this hypothesis (primary outcome). Secondary objectives will include assessing short- and long-term side-effects and developing specific biomarkers of sensitivity to therapy. Patients will be recruited, treated and followed at IRCCS G Gaslini and IRCCS Bambino Gesù where laboratory studies will be performed at in-site facilities

Publications & conference data

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

1. Rituximab vs Low-Dose Mycophenolate Mofetil in Recurrence of Steroid-Dependent Nephrotic Syndrome in Children and Young Adults: A Randomized Clinical Trial.
   Ravani P, Lugani F, Drovandi S, Caridi G, et al · · 2021 · cited 33× · PMID 33616641 · DOI 10.1001/jamapediatrics.2020.6150
2. Randomised controlled trial comparing rituximab to mycophenolate mofetil in children and young adults with steroid-dependent idiopathic nephrotic syndrome: study protocol.
   Lugani F, Angeletti A, Ravani P, Vivarelli M, et al · · 2021 · cited 8× · PMID 34845071 · DOI 10.1136/bmjopen-2021-052450