Minimal change disease
Conditions
Interventions
Experimental group:Phase one: a 4-week treatment of Rituximab
Phase two: a 12-week treatment of eliminating dampness prescriptions.
Placebo controlled group:Phase one: a 4-week treatment of Rituximab
Phase two: a 12-week treatment of placebo of eliminating dampness prescriptions.
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
14 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for minimal change disease as defined in the KDIGO 2021 CLINICAL PRACTICE GUIDELINE FOR THE MANAGEMENT OF GLOMERULAR DISEASESMinimal change disease confirmed by renal biopsy; 2.Aged 14 to 80 years old; 3.The 24-hour urinary protein excretion increase by 50% during the past 3 months or the 24-hour urinary protein exceed 1gram/24h or urine protein/creatinine ratio exceed 1gram/gram; 4.Written informed consent is gained.
Exclusion criteria
Exclusion criteria: 1.Pregnancy or nursing or has a pregnancy willing during the study period; 2.Minimal change of renal pathology caused by secondary factors; 3.Patients with other uncontrolled severe diseases including: severe heart failure (NYHA grade IV); water electrolyte and acid-base balance disorders; level of alanine aminotransferase or aspartate aminotransferase is three times higher than the upper limit of normal; Blood white blood cell count hemoglobin level platelet count is lower than the lower limit of normal value or with hematopoietic system abnormalities or tumors (e.g. lymphocyte proliferation); history of primary or secondary immunodeficiency and hypersensitivity; history of mental illness; 4. During the active phase of severe infectious diseases or co-infection with tuberculosis hepatitis AIDS and other infectious diseases; 5.Has any contraindication of rituximab and/or glucocorticoids; 6.Allergy or intolerance to investigational agent; 7.Participating in other clinical trials; 8.Considered by the investigators that are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in the incidence of recurrence;Differences in urinary protein level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in the use of other immunosuppressive drugs;Differences in glucocorticoid dosage;Difference in average days from induced remission to first relapse;Difference in serum creatinine level; | — |
Countries
China
Contacts
Public ContactLiu Xusheng
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed