Obinutuzumab in the Management of Idiopathic Membranous Nephropathy

NCT05845762 | Unknown FDA Drug

• 1 other identifier: Obinutuzumab-IMN
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

To observe the efficacy and safety of obinutuzumab in Chinese population with idiopathic membranous nephropathy and guide clinical management.

Conditions

Idiopathic Membranous Nephropathy

Outcome Measures

Primary Outcomes (1)

• Remission

  Urine protein quantification was less than 0.3g/24h, renal function was stable and serum albumin was \> 35g / L or urinary protein quantification decreased by 50% from baseline and between 0.3-3.5g/24h

  6 months

Study Arms (2)

Response

1000mg i.v. per day

Drug: Obinutuzumab Injection

Non-response

1000mg i.v. per day

Drug: Obinutuzumab Injection

Interventions

Obinutuzumab Injection DRUG

1000mg intravenous injection

Also known as: Obinutuzumab

Non-response; Response

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Idiopathic membranous nephropathy patients receiving obinutuzumab treatment

You may qualify if:

• Clinical diagnosis of nephrotic syndrome.
• The diagnosis of IMN was confirmed by renal biopsy pathology (light and electron microscopy) or if the serum pla2r antibody was greater than 20 IU / ml.
• Those who have failed glucocorticoid therapy combined with cyclophosphamide or other immunosuppressive agents or rituximab, or have recurrent relapses.
• Treatment with inotuzumab.

You may not qualify if:

• Patients with positive HBV serologic markers (HBsAg or / and HBeAg), HCV positivity, or abnormal liver function tests (alt, AST, or bilirubin more than 2 times the upper limit of normal and persistently elevated for 2 weeks).
• Patients with congenital or acquired immunodeficiency, or combined infections such as active tuberculosis, active CMV, etc. Patients with CO morbid severe infections requiring intravenous antibiotics.
• Patients with other serious physical or psychological diseases.
• Patients with congenital heart disease, arrhythmia, heart failure and other severe cardiovascular disease, tumor.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

obinutuzumab

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 6, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05