Trial of Plasma Exchange for Severe Crescentic IgA Nephropathy

• Status: Terminated
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Crescentic IgA nephropathy (CreIgAN) has a poor prognosis despite aggressive immunosuppressive therapy. The efficacy of plasma exchange (PE) in CreIgAN is not well defined. This study will evaluate the efficacy and safety of plasma exchange as adjunctive therapy for severe crescentic IgA nephropathy compared to pulse methylprednisolone on a background of oral prednisolone and cyclophosphamide in prevent kidney failure.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Treatments: Immunosuppressive Agents; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. Biopsy-proven within 3ws

2. Primary IgAN or Henoch-Schönlein Purpura nephritis of crescent >50%(>8 glomeruli)

3. Serum creatinine ≥ 200 μmol/l， rapidly deterioration of renal function

Exclusion Criteria:

1. <14 or >65 years old

2. With high Scr requiring dialysis for≥ 3w

3. Scr>200μmol/L ≥1 yr before entry

4. Main of old crescent ; Fibrous crescent>50%

5. Anti-glomerular basement membrane (GBM) or antineutrophil cytoplasmic antibody (ANCA) antibody positive

6. Women in gestational and lactational period

7. With diabetes or uncontrollable malignant hypertension or Thrombotic Microangiopathy

8. With Malignancy

9. Chronic active infection including HBV hepatitis C virus (HCV) HIV or active tuberculosis

10. Other autoimmune disease

11. A second clearly defined cause of renal failure

12. Contraindication of plasma exchange treatment or steroid pulse

13. Patients who are unlikely to comply with the study protocol in the view of the treating physician.