Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Hydroxychloroquine; Molecular Mechanisms of Pharmacological Action; Valsartan

Criteria

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