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Efficacy and safety of Rituximab in the maintenance treatment of minimal-change nephrotic syndrome in adults: a prospective, single-center, randomized controlled study

Efficacy and safety of Rituximab in the maintenance treatment of minimal-change nephrotic syndrome in adults: a prospective, single-center, randomized controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065822
Enrollment
Unknown
Registered
2022-11-16
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Minimal-change nephrotic syndrome

Interventions

Glucocorticoid treatment group:Glucocorticoid
Rituximab treatment group:Rituximab

Sponsors

Department of Nephrology, Army Medical Center of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary participation and signed informed consent; 2. Unlimited gender, adults (18-75 years old) are firstly diagnosed with nephrotic syndrome; 3. The pathology of renal biopsy was minimal change disease; 4. In complete remission within 8 weeks of adequate glucocorticoid treatment.

Exclusion criteria

Exclusion criteria: 1. Women with recent birth planning, pregnancy or lactation; 2. Unable to understand the potential risks and benefits of the study and to follow-up assessment as required; 3. History of tuberculosis infection; 4. Any existing active infection; 5. HBsAg or HBV-DNA positive, HIV positive, HCV positive; 6. Combined with its diabetic nephropathy or other diseases requiring immunosuppressive agent treatment, such as: other immune diseases, connective tissue diseases, amyloidosis; 7. Clinical diagnosis of secondary minimal change disease (such as lymphoproliferative disease, NSAIDs drug related); 8. Chronic infection is not cured; 9. Infection has occurred in the previous 2 weeks; 10. Kidney replacement (hemodialysis, peritoneal dialysis, or kidney transplantation) treatment; 11. There are any more complex medical problems that may interfere with research behavior or lead to increased risk, such as malignancy, severe coronary heart disease, hematological disease, liver disease; 12. Patients who have participated in clinical trials of other drugs or are participating in other clinical trials within 1 month prior to participating in this trial.

Design outcomes

Primary

MeasureTime frame
Urine protein;blood serum albumin;

Secondary

MeasureTime frame
B lymphocyte count;serum creatinine;

Countries

China

Contacts

Public ContactHuanzi Dai

Department of Nephrology, Army Medical Center of PLA

dhz084426@163.com+86 13983828951

Outcome results

None listed

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