臨床研究等提出・公開システム

A PHASE III, INTERNATIONAL, MULTICENTER, RANDOMISED OPEN LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB VERSUS MMF IN PATIENTS WITH CHILDHOOD ONSET IDIOPATHIC NEPHROTIC SYNDROME

A phase III trial of RO5072759 in childhood onset idiopathic nephrotic syndrome patients

Will Pendergraft, M.D., Ph.D.

F. Hoffmann-La Roche Ltd

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

+81-120-189-706

clinical-trials@chugai-pharm.co.jp

Complete

Jan. 31, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

-Diagnosis of FRNS or SDNS before the age of 18 years
-Must be in complete remission defined by the absence of edema, UPCR =< 0.2 g/g at screening, and have three consecutive daily urine dipstick readings of trace or negative for protein within the week prior to randomization
-Must have had at least one relapse in the 6 months prior to screening, after discontinuation of or while receiving oral corticosteroids and/or immunosuppressive therapy to prevent relapses
-Estimated glomerular filtration rate (eGFR) within normal range for age

-Secondary nephrotic syndrome
-History of steroid resistant nephrotic syndrome
-History of genetic defects known to directly cause nephrotic syndrome
-Treatment with other immunosuppressive medications to prevent relapse, other than MMF or oral corticosteroids within 2 months prior to randomization
-Participants demonstrating prior treatment failure to MMF as defined by two or more relapses in any 6-month period of time while receiving MMF for at least a 6-month duration
-Participants in the judgment of the investigator likely to require systemic corticosteroids for reasons other than idiopathic nephrotic syndrome during the study

Both

Childhood Nephrotic Syndrome

Obinutuzumab: Participants in Obinutuzumab (Group A) will receive obinutuzumab 1000 milligrams (mg) (or 20 mg/ kilogram [kg] for participants <45 kg) administered by intravenous (IV) infusion on Days 1, 15, 168 (Week 24), and 182 (Week 26).
Mycophenolate Mofetil: MMF (Group B) will be titrated by Week 4 to a target dose of 1200 mg/m2/day (maximum 2 g/day), given in two divided doses (600 mg/m2 BID).

Efficacy
Percentage of Participants with Sustained Complete Remission at 1 year

Safety, Efficacy, Phamacokinetics, Phamacodynamics
-Overall Relapse Free Survival (RFS) [Time Frame: At Week 52]
-Probability of RFS at Week 52 [Time Frame: At Week 52]
-Cumulative corticosteroid dose (prednisone or equivalent adjusted for time on study)[Time Frame: At Week 52]
-Number of relapses on randomized study treatment[Time Frame: At Week 52]

+81-78-382-6669

Nov. 28, 2022

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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