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Standard dose Rituximab for membranous nephropathy: a multi-center prospective cohort study

Standard dose Rituximab for membranous nephropathy: a multi-center prospective cohort study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042674
Enrollment
Unknown
Registered
2021-01-26
Start date
2021-01-18
Completion date
Unknown
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

syndrome disease

Interventions

experimental group:RTX treatment

Sponsors

Jiangsu Province People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) 18-75 years old (including 18 and 75 years old), regardless of gender and nationality; (2) The patients with refractory membranous nephropathy (MN) or newly diagnosed membranous nephropathy were at medium or high risk. (3) The laboratory examination met the following conditions: 24h urinary protein >= 3.5g, serum albumin = 30 ml / min / 1.73 m2; CD19 + B lymphocyte count > 5 / mm3, neutrophil count >= 1.5 x 10^9 / L and platelet count >= 75 x 10^9 / L; (4) Informed consent was signed by the patient.

Exclusion criteria

Exclusion criteria: (1) eGFR < 30 ml/min/1.73 m2 (2) The onset of nephrotic syndrome in infants and children; (3) Abnormal liver function, alanine aminotransferase or aspartate aminotransferase 2 times higher than the upper limit of normal value; (4) Potential hepatitis B or HIV positive, systemic lupus erythematosus, amyloidosis, allergic purpura; (5) Secondary nephrotic syndrome (6) More than one infection (sepsis, sinusitis, bronchitis, pneumonia, febrile infection, herpes zoster, respiratory tract infection, fungal infection, infection of unknown etiology) occurred in the past month; (7) Current or previous anti tuberculosis treatment; (8) Severe impairment of immune response (such as hypoimmunoglobulinemia, severe decrease of CD4 or CD8 cell count) (9) Severe cardiovascular and cerebrovascular complications such as myocardial infarction, heart failure and cerebral hemorrhage occurred in the past six months; (10) Patients with neutrophil count less than 1.5 x 10^9 / L and / or platelet count less than 75 x 10^9 / l had CD19 + B lymphocyte count less than 5 / mm3; (11) Immunosuppressants (cytotoxic drugs, Tripterygium wilfordii preparations, etc.) can not be stopped temporarily; (12) Pregnancy or lactation; (13) Allergic to active ingredients or any excipients in the prescription.

Design outcomes

Primary

MeasureTime frame
remission rate;

Secondary

MeasureTime frame
Incidence of complications;

Countries

China

Contacts

Public ContactChangying Xing

Department of Nephrology, Jiangsu Province People's Hospital

cyxing62@126.com+86 13813821064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026