A multicenter, randomized, controlled clinical trial of Hydroxychloroquine or new Tripterygium compound in the treatment of IgA nephropathy

Phase 1

Recruiting

• Conditions: IgA nephropathy

• Registration Number: ITMCTR2100004723
• Lead Sponsor: Peking University First Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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;
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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in 24-hour urinary protein relative to baseline after 6 months of treatment;

Secondary Outcome Measures

Name	Time	Method
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;