Obinutuzumab in kidney transplantation: Past, present, and future

Table 3 Ongoing studies with Obinutuzumab in nephrology settings

NCT number	Study title	Type	Phase	Condition(s) studied	Summary	Status	Sponsor
NCT02550652	A Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients with Lupus Nephritis	I	II	LN	Compare efficacy and safety of OBI plus MMF/MPA with placebo plus MMF/MPA in patients with proliferative LN	Completed	Hoffmann-La Roche
NCT04629248	A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants with Primary Membranous Nephropathy (MAJESTY)	I	II	pMN	Evaluate efficacy, safety, PD/PK of OBI compared with tacrolimus in pMN	Active, not recruiting	Hoffmann-La Roche
NCT05050214	Obinutuzumab in primary MN (ORION)	I	II	pMN		Active, not recruiting	Mario Negri Institute for Pharmacological Research
NCT05845762	Obinutuzumab in the management of Idiopathic Membranous Nephropathy	O		Idiopathic MN		Not yet recruiting	Qianfoshan Hospital
NCT06120673	REmission in Membranous Nephropathy International Trial (REMIT)	I	III	pMN	Multi-centre, prospective, randomized, open-label, parallel-group trial: 224 adult participants will be recruited to receive either CCS and CP or OBI	Not yet recruiting	The University of Queensland
NCT02586051	A Study of Obinutuzumab to Evaluate Safety and Tolerability in Hypersensitized Adult Participants with End Stage Renal Disease Awaiting Transplantation	I	Ib	End-stage renal disease awaiting KT	Assessment of safety and tolerability of OBI regimen (1 infusion vs 2 infusions) at week 24 of desensitization phase and week 28 post-KT	Completed	Hoffmann-La Roche
NCT06781944	OBINUTUZUMAB Versus Cyclophosphamide + Glucocorticoids in Primary Membranous Nephropathy (Blossom Study)	I	III	pMN	Compare OBI against CP combined with CCS in pMN patients. Primary endpoint: Non-inferiority	Recruiting	Huashan Hospital
NCT06295770	Obinutuzumab in Treatment of Fibrillary Glomerulonephritis	I	II	FGN	Efficacy and safety in FGN	Recruiting	Mayo Clinic
NCT04983888	Obinutuzumab in Primary FSGS	I	II	FSGS	Safety and efficacy in inducing complete or partial remission of proteinuria	Active, not recruiting	Mayo Clinic
NCT05786768	Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid-Dependent and Frequently Relapsing Nephrotic Syndrome (OBIRINS)	I	II–III	FRNS, SDNS	Assess efficacy and safety of a single infusion of low-dose OBI compared to a single infusion of RTX in children with FRNS/SDNS	Recruiting	Assistance Publique-Hôpitaux de Paris
NCT04221477	A Study to Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)	I	III	LN	Evaluate efficacy, safety, and PK of OBI compared with placebo in patients with ISN/RPS class III or IV LN when added on to standard-of-care therapy (MMF + CCS)	Active, not recruiting	Hoffmann-La Roche
NCT06265220	AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus	I	I	LN	Assess safety, tolerability, and preliminary activity of AB-101 plus a B-cell depleting mAb after CP and fludarabine in adult with relapsed/refractory LN class III/IV	Recruiting	Artiva Biotherapeutics, Inc.
NCT05039619	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents with Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants (POSTERITY)	I	II	LN	Evaluate safety, efficacy and PK of OBI in adolescent aged 12-17 years with biopsy-confirmed proliferative LN and pediatrics aged 5-11 years with LN	Recruiting	Hoffmann-La Roche
NCT05627557	A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants with Childhood Onset Idiopathic Nephrotic Syndrome (INShore)	I	III	INS, FRNS, SDNS	Assess efficacy, safety, and PK/PD of OBI compared with MMF in patients with FRNS SDNS	Active, not recruiting	Hoffmann-La Roche
NCT04702256	Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF (OBILUP)	I	III	LN	Demonstrate that a regimen free of additional oral CCS but with OBI (and MMF) is not inferior to a regimen based on oral CCS and MMF in achieving complete renal response at week 52 without receiving CCS above a prespecified dose	Recruiting	Assistance Publique-Hôpitaux de Paris

CCS: Corticosteroids; CP: Cyclophosphamide; FGN: Focal glomerulonephritis; FRNS: Frequently relapsing nephrotic syndrome; FSGS: Focal segmental glomerulosclerosis; ISN/RPS: International Society of Nephrology/Renal Pathology Society; KT: Kidney transplant; LN: Lupus nephritis; mAb: Monoclonal antibodies; MMF/MPA: Mycophenolate mofetil/mycophenolic acid; MN: Membranous nephropathy; OBI: Obinutuzumab; PD: Pharmacodynamics; PK: Pharmacokinetics; SDNS: Steroid-dependent nephrotic syndrome.