IgA nephropathy
Conditions
Interventions
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >18 years; 2.Primary IgA nephropathy confirmed by renal biopsy; 3.After 3 months of treatment with the maximum tolerated dose of RAS blocker recommended by treatment guidelines, urinary protein was still greater than 0.75g/d; 4.eGFR >= 30 mL/min/1.73m^2.
Exclusion criteria
Exclusion criteria: 1.IgA nephropathy patients with indications of hormonal and immunosuppressive therapy, such as: (1) Minimal pathological nephropathy with IgA deposition; (2) In the past 12 months, more than 50% of glomeruli on renal biopsy had cell/cellular fibrous crescents; 2.Other indications of immunosuppressive therapy, such as interstitial nephritis, membranous nephropathy, etc.; 3.Systematic use of hormones or other immunosuppressive therapy within the past 6 months, or systematic use of hydroxychloroquine or Tripterygium wilfordii preparation within the past 6 months; 4.Malignant hypertension or other uncontrolled severe hypertension (systolic blood pressure > 160mmHg or diastolic blood pressure > 110mmHg); 5.A history of malignancy within the past 5 years, excluding treated non-melanoma skin cancer (i.e. squamous or basal cell carcinoma); 6.Other causes of renal instability, such as acute kidney injury due to heavy hematuria (past events are not excluded as causes); 7.Significant liver disease, such as ALT levels 2.0 times higher than the upper normal limit (ULN), or total bilirubin 1.5 times higher than the ULN; 8.Patients who were in lactation or prenancy or had fertility requirements; 9.Active systemic infection or severe infection within 1 month prior to enrolment, including HIV, hepatitis C virus, hepatitis B virus; 10.White blood cell count < 3.0x10^9/L, or anemia (hemoglobin level below 80g/L), platelet count below 80x10^9/L, or other blood disorders; 11.Patients who have evidence of active digestive tract ulcer; 12.Patients who complicated with fundus lesions; 13.Patients with G6PD deficiency or hypersensitivity to 4-aminoquinoline compounds, or with other contraindications to the use of hydroxychloroquine; 14.Patients who the investigator considered unable to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in 24-hour urinary protein relative to baseline after 6 months of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Decline rate of eGFR 12 months after treatment;Changes in ACR and PCR relative to baseline after 6 and 12 months of treatment;Changes in eGFR relative to baseline after 6 and 12 months of treatment;Changes in 24-hour urinary protein relative to baseline after 12 months of treatment; | — |
Countries
China
Contacts
Public ContactZhang Hong
Peking University First Hospital
Outcome results
None listed