ITMCTR2100004723
Recruiting
Phase 1
A multicenter, randomized, controlled clinical trial of Hydroxychloroquine or new Tripterygium compound in the treatment of IgA nephropathy
ConditionsIgA nephropathy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- IgA nephropathy
- Sponsor
- Peking University First Hospital
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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;
Outcomes
Primary Outcomes
Not specified
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