Clinical trial · Interventional
Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy
Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy:a Single Center Prospective Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis in the world.There is to date no curative therapy for patients with IgAN.It is considered that dendritic cells, Toll-like receptor (TLR) 9 and cytokines interleukin-6 (IL-6), and interferon-alpha (IFN-a) and tumor necrosis factor-alpha (TNF-α), play an important role in the aberrant mucosal response. Hydroxychloroquine is an antimalarial agent and had a notable impact on immune activation by the reduction of circulating activated immune cells that including decreased TLR-expressing cells, reduced IFN-secreting plasmacytoid dendritic cells, reduced production of inflammatory cytokines including interferon alpha, IL-6 and TNF alpha. Recent studies showed hydroxychloroquine had a benefit for renal remission and could retard the onset of renal damage in patients with lupus nephritis. hydroxychloroquine may have the potential effect in IgA nephropathy, alleviated the proteinuria and had the renal protect effect. This will be a single center, prospective, randomized, controlled study to assess the utility of hydroxychloroquine in IgAN patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary IgA Nephropathy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydroxychloroquine Sulfate | Drug | Hydroxychloroquine | ALIAS |
| Valsartan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- valsartan only:control group
- description
- valsartan (160mg/d)
- interventionNames
- Drug: Valsartan
- type
- EXPERIMENTAL
- label
- hydroxychloroquine with valsartan:study group
- description
- valsartan (160mg/d) and Hydroxychloroquine Sulfate ( 400mg/d, twice daily)
- interventionNames
- Drug: Hydroxychloroquine Sulfate
- Drug: Valsartan
Primary outcomes (1)
- measure
- Incidence of Remission (Complete [CR] or Partial [PR]) at Week 24
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. biopsy proven primary IgA nephropathy 2. age 18-60 years 3. proteinuria range from 0.5 to 1.5g/d 4. serum creatinine ≤132.6μmol/L 5. normal blood pressure or blood pressure ≤130/80 mmHg in patients with hypertension Exclusion Criteria: 1. Hypersensitivity to chloroquine or to hydroxychloroquine 2. blood pressure \<90/60 mm Hg 3. pregnancy and breastfeeding women 4. renal artery stenosis 5. Rapidly progressive renal insufficiency 6. systemic lupus erythematosus or other connective tissue diseases 7. Henoch- schoenlein purpura 8. other nephritis 9. diabetes mellitus 10. retinopathy 11. other contraindication of hydroxychloroquine 12. severe hepatic insufficiency 13. G6PD deficiency 14. psoriasis or porphyria 15. malignant hypertension 16. viral hepatitis or other infections 17. treatment with steroids or cytotoxic drugs during the previous three months 18. psychiatric disorder 19. not suitable for the study judged by investigator
References
Publications (1)
- DERIVEDTunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3. PMID 38299639