AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

OBINOTUZUMAB Versus Cyclophosphamide + Glucocorticoids in Primary Membranous Nephropathy(Blossom Study)

RecruitingPhase 3Ages 18 Years - 75 YearsAllHuashan Hospital
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

This is a randomized, parallel group, active-controlled, open-label, Phase III study comparing the efficacy and safety of obinutuzumab versus cyclophosphamide combined with glucocorticoids in patients with primary membranous nephropathy (pMN). Approximately 144 patients with pMN who have been diagnosed by biopsy or serum anti-PLA2R antibody will be enrolled. Intervention: Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26 Comparator: Cyclical cyclophosphamide and glucocorticoids Methylprednisolone 500 mg iv will be given for 3 consecutive days at the start of month 1,3,5 and followed by prednisone 0.5mg/kg/d (max 40 mg/d) for 27 days. Oral cyclophosphamide will be given for 30 days in month 2, 4, 6.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Aged 18๏ฝž75 years (including 18 and 75)old at the time of signing Informed Consent Form * pMN patients diagnosed according to renal biopsy (original biopsy needs to include light, immunofluorescence, and electron microscopy) within 5 years or serum anti-PLA2R antibody (โ‰ฅ14 RU/ml ) * 24-hour UPCR โ‰ฅ 4 g/g and serum albumin (sALB) \< 30 g/L,despite being treated with ACEi and/or ARB for โ‰ฅ 6 months prior to screening, or 24-hour UPCR โ‰ฅ 5 g/g and sALB \< 30 g/L , despite being treated with ACEi and/or ARB for โ‰ฅ 3 months prior to screening; or 24-hour UPCR โ‰ฅ 8 g/g and sALB \< 25 g/L, despite being treated with ACEi and/or ARB for โ‰ฅ 1 month prior to screening,. * eGFR โ‰ฅ40 mL/min/1.73m2 (CKD-EPI), a renal biopsy is required to exclude renal damage due to other co-morbidities if eGFR \<60mL/min/1.73 m2. * Ability to comply with the study protocol, in the investigator's judgment Exclusion Criteria: * Patients with a secondary cause of MN (e.g. hepatitis B, systemic lupus erythematosus, medications, malignancies) * Type 1 or 2 diabetes mellitus * eGFR \<40 mL/min/1.73m2 (CKD-EPI) or dialysis or kidney transplantation * Evidence of 50% reduction in proteinuria or serum anti-PLA2R antibody within 6 months prior to screening
๐Ÿ’Š

What it tests

  • Obinutuzumab
  • CTX combined with Glucocorticoids
๐Ÿ“

Where

1 site
Huashan Hospital, Fudan University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy