Treatment of IgA Nephropathy According to Renal Lesions

• Status: Recruiting
• Trial end date: 2022-02-20
• Target enrollment: 0
• Participant gender: All

Summary

TIGER study (Treatment of IgA nEphropathy according to Renal lesions) is a prospective openly randomized controlled study.

The main objective is to evaluate the efficacy of early corticotherapy + RAS blockade (versus RAS blockade alone) after two years of evolution in IgAN patients with severe histological lesions The study will include 122 IgAN patients, it is scheduled to start in september 2017.

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

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Criteria

Inclusion Criteria:

1. Age >= 18 years

2. Patient with IgAN

3. Renal biopsy < 45 days before inclusion visit

4. PCR ratio >0.75 g/g (within 30 days before or after the renal biopsy)

5. Renal biopsy with at least 8 glomeruli, disclosing at least 2 criteria among:

• mesangial proliferation (according to Oxford criteria)

• endocapillary proliferation (according to Oxford criteria)

• tubulointerstitial fibrosis (according to Oxford criteria) >25% of the biopsy

• segmental glomerulosclerosis (according to Oxford criteria)

• at least 1 cellular/fibrocellular crescents (C1 according to Oxford criteria)

6. Patient with Social Security Insurance or CMU

7. Patient having signed an informed consent

Exclusion Criteria:

1. >30% increase of serum creatinine after starting RAS blockade therapy (≥ 15 days and ≤ 6 weeks) only for patient under RAS <45 days of the inclusion visit

2. >50% cellular/fibrocellular crescents, or >50% tubulointerstitial fibrosis or >50% globally sclerotic glomeruli

3. Nephrotic syndrome with minimal change disease and IgA deposits

4. eGFR <20 ml/min/1,73m2 (CKD-EPI formula) within 30 days before or after the renal biopsy

5. Uncontrolled blood pressure (Systolic blood pressure >180 mmHg or diastolic blood pressure > 110 mmHg)

6. Previous corticosteroids treatment (>20 mg/d during more than 15 days, within the last 3 months before the renal biopsy)

7. Pregnancy or breast feeding or women without sufficient contraception

8. Secondary known forms of IgAN

9. Henoch-Schoenlein purpura

10. Additional other chronic renal disease

11. Contraindication for immunosuppressive therapy, including active intestinal bleeding, active gastric or duodenal ulcer; active infection; any malignancy in a last years before the inclusion; severe psychiatric disease; living vaccines; anti-inflammatory dosages of acetylsalicylic acid

12. Contraindication for RAS blockade therapy

13. Known allergy or intolerance to corticoids or lactose

14. Organ transplant patient