IgA nephropathy
Conditions
Interventions
Tofacitinib treatment group:Tofacitinib 5mg bid
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: patients may enter the screening period when they meet conditions a-c, during which they follow a routine treatment with an intensive support approach, and may be enrolled when they meet conditions a-e. a) Age: 18-69 years. b) Primary IgA nephropathy confirmed by renal biopsy pathology within the last 1 year. c) Patient or family able to understand the study protocol and willing to participate in this study by providing written informed consent. d) eGFR = 30 ml/min/1.73m2 (calculated using the CKD-EPI formula) after 1-3 months of intensive supportive therapy. e) After at least 3 months of intensive supportive therapy, a total 24-hour urinary protein 0. 75-3. 5g
Exclusion criteria
Exclusion criteria: Patients cannot be selected for clinical studies when any of the following conditions are present: a) Secondary IgA nephropathy, such as comorbid lupus, cirrhosis, IgA vasculitis, etc., or comorbid other chronic kidney disease. b) Use of immunosuppressive therapy, including hormones or various immunosuppressive agents, within the past 1 year. c) Presence of other indications for the use of hormones or immunosuppressive agents, including IgA nephropathy combined with microscopic lesions, and the presence of crescentic bodies in >50% of glomeruli seen on renal puncture pathology d) Combination of other conditions affecting the use of Tofacitinib. (1)Active or occult infection, including HBV, CMV infection or latent or active TB (2)Diagnosis of a malignant neoplasm within the last 5 years. (3)Current pregnancy or lactation (4)Females of childbearing age with childbirth plans during drug administration e) Failure to control hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 110 mmHg) f) Patient is unable to comply with the study protocol in the judgment of the clinician g) Concurrent enrollment in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| urine protein; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum creatinine;eGFR; | — |
Countries
China
Contacts
Public ContactXuemei Li
Peking Union Medical College Hospital
Outcome results
None listed