Proliferative glomerulonephritis with monoclonal immunoglobulin deposits
Conditions
Interventions
BCD group:Dexamethasone (20mg~40mg, adjusted according to the patients condition, intravenous infusion) is given first, then cyclophosphamide (300mg/m^2 body surface area, maximum 500mg, according to
Dosing once a week, 4 times a cycle, a 28-day cycle
A total of 6 cycles
Rituximab group:375mg/m^2 body surface area, intravenous infusion, once a week, a total of 4 times
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age>=18 years; Patients with PNGMID confirmed by renal biopsy, hematuria IFE was negative and there was no evidence of monoclonal cells on bone marrow examination; 24-hour urine protein quantification >=1g; Estimated glomerular filtration eGFR>=20 ml/min/1.73 m^2 (measured using CKD-EPI formula); Neutrophil count>=1.0×10^9/L; Hemoglobin content>=80g/L; Platelet count>=50×10^9/L; alanine aminotransferase < = 2.5 times the upper limit of normal; aspartate aminotransferase < = 2.5 times the upper limit of normal; Total bilirubin < = 1.5 times the upper limit of normal; Women who are able to conceive must abstain from sexual activity or use 2 reliable contraceptive methods at the same time; During the study and for 1 year after discontinuation of cyclophosphamide, female patients are required to agree not to donate eggs for the purpose of assisted reproduction.
Exclusion criteria
Exclusion criteria: Prior treatment with bortezomib and rituximab; hematologic malignancies, such as multiple myeloma; uncontrolled cardiac insufficiency; Combined with other malignant non-hematologic malignancies; COPD with forced breathing capacity in 1 second (FEV1) < 50% of predicted normal; HIV-positive; HBsAg positive; positive for HCV antibodies; Allergy to known study drug; Presence of a concomitant medical condition or disease (e.g., active systemic infection) that may interfere with study procedures or results, or that the investigator judges would pose a certain risk to enrollment in this study; Known or suspected inability to comply with the study protocol (such as alcoholism, drug dependence, or psychological disorders, etc.); Certain circumstances of the study participant that, in the opinion of the investigator, are not in the best interest of the study participant or that may hinder, limit, or confound the assessment as specified in the study protocol; Female patients who are pregnant or lactating, or who plan to become pregnant during this study or within 1 year of discontinuation of cyclophosphamide; Have had major surgery within 2 weeks prior to Day 1 of the first treatment cycle, or have not fully recovered from surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proteinuria; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum creatinine;Estimating glomerular rate overrate;Serum albumin; | — |
Countries
China
Contacts
Public ContactFude Zhou
Peking University First Hospital
Outcome results
None listed