Treatment of IgA Nephropathy According to Renal Lesions

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2022
• Main ID: NCT03188887
• Date of registration: 02/05/2017
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Treatment of IgA Nephropathy According to Renal Lesions TIGER
• Scientific title: Treatment of IgA Nephropathy According to Renal Lesions
• Date of first enrolment: February 20, 2018
• Target sample size: 62
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03188887
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Dominique JOLY, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

• Name: Eric ALAMARTINE
• Affiliation: CHU Saint-Etienne

• Name: Khalil El Karoui
• Affiliation: Henri Mondor University Hospital

Key inclusion & exclusion 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 nephroprotection therapy (= 15 days
and = 6 weeks) only for patient under nephroprotection <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 orSGLT2i blockade therapy

13. Known allergy or intolerance to corticoids or lactose

14. Organ transplant patient



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

IgA Nephropathy

Intervention(s)

Drug: Renin Angiotensin system (RAS) blockade or Inhibitors of sodium glucose transporter 2 (SGLT2i)

Drug: corticotherapy

Primary Outcome(s)

Failure at 24 months [Time Frame: Month 24]

Secondary Outcome(s)

Evolution of proteinuria assessed as : - the absolute value of proteinuria at 12 and 24 months - the absolute difference of proteinuria from baseline at 12 and 24 months [Time Frame: Month 12 and 24]

SF36 scale at 24 months [Time Frame: Month 24]

Proportion of patients with persistent severe histological lesions in repeat kidney biopsy at 12 months [Time Frame: Month 12]

Failure at 6 months [Time Frame: Month 6]

Prognosis markers of failure at 24 months [Time Frame: Month 24]

Evolution of GFR at 12 months assessed as :- the absolute value of GFR - the absolute difference of GFR from the baseline - the annual degradation (ml/min /1,73m2/year) of GFR during the 12 months [Time Frame: Month 12]

Evolution of GFR at 24 months assessed as :- the absolute value of GFR - the absolute difference of GFR from the baseline - the annual degradation (ml/min /1,73m2/year) of GFR during the 24 months [Time Frame: Month 24]

Failure at 12 months [Time Frame: Month 12]

Number of side effects [Time Frame: Month 24]

SF36 scale at 12 months [Time Frame: Month 12]

Secondary ID(s)

P140931

2016-004507-31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors