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A prospective, open, randomized controlled study of hydroxychloroquine sulfate in the treatment of adult Henoch Schonlein purpura nephritis

A prospective, open, randomized controlled study of hydroxychloroquine sulfate in the treatment of adult Henoch Schonlein purpura nephritis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057905
Enrollment
Unknown
Registered
2022-03-21
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Henoch Schonlein purpura nephritis

Interventions

Control group:Conventional therapy

Sponsors

Daping Hospital, Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Voluntary participation and signed informed consent; 2. Unlimited gender, age >= 18 years; 3. The pathology of renal biopsy was Henoch Schonlein purpura nephritis; 4. Urinary protein quantification: 0.3-3.5 g/d; 5. Serum albumin > 30 g/L; 6. Glomerular filtration rate (GFR) was > 30 mL/min/1.73m2; 7. Be able to follow the research or follow-up process.

Exclusion criteria

Exclusion criteria: 1. Women who have recently planned to have a baby, are pregnant or are breastfeeding; 2. Inability to understand the potential risks and benefits of the study and to follow up and evaluate as required; 3. No capacity for civil conduct; 4. History of drug or alcohol abuse; 5. There are active infected persons; 6. Complicated with other major organ vasculitis manifestations, such as gastrointestinal bleeding, severe abdominal pain, pulmonary hemorrhage, cerebral hemorrhage, etc.; 7. Patients with other diseases such as diabetic nephropathy, immune diseases, connective tissue diseases, amyloidosis, and those requiring immunosuppressive therapy; 8. The pathological findings of renal biopsy showed that the crescent body was >20% or combined with cellulose-like necrosis; 9. Patients with known renal artery stenosis; 10. Fundus screening for patients with eye diseases who are not suitable to use hydroxychloroquine sulfate; 11. Any more complex medical problems that may interfere with the conduct of research or lead to increased risk, such as malignancies, diseases of the blood system, heart disease, liver disease, AIDS, viral hepatitis, etc.; 12. Patients who have participated in or are participating in other drug clinical trials within 1 month prior to participating in this trial.

Design outcomes

Primary

MeasureTime frame
Urinary protein change rate;24 h urinary protein;Urinary microalbumin/urinary creatinine;

Secondary

MeasureTime frame
Serum creatinine;Estimated glomerular filtration rate, eGFR;Urine routine red blood cell count;Remission rate of complications;Recurrence rate;Adverse event rate;

Countries

China

Contacts

Public ContactDai Huanzi

Army Medical University

dhz084426@163.com+86 13983828951

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026