Treatment of IgA Nephropathy According to Renal Lesions

NCT03188887 | Completed Phase 3

• 2 other identifiers: P1409312016-004507-31
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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 + Renin Angiotensin System (RAS) blockade or inhibitors of Sodium glucose transporter 2 (SGLT2i) (versus RAS blockade or SGLT2i alone) after two years of evolution in IgAN patients with severe histological lesions.

Conditions

IgA Nephropathy

Keywords

NIgA; Kidney biopsy; GFR; Corticotherapy

Outcome Measures

Primary Outcomes (1)

• Failure at 24 months

  Failure at 24 months will be defined as : * Proteinuria/creatinuria ratio (PCR) \> 0,5 g/g * or mGFR \< 80% of initial mGFR (or eGFR if unavailable) * or loss of more than 10 ml/min/1,73m2 of initial mGFR (or eGFR if unavailable) * or end stage renal disease (ESRD) * or renal transplantation * or death

  Month 24

Secondary Outcomes (10)

• Failure at 6 months

  Month 6

• Failure at 12 months

  Month 12

• Proportion of patients with persistent severe histological lesions in repeat kidney biopsy at 12 months

  Month 12

• 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

  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

  Month 24

Study Arms (2)

CONTROL

ACTIVE COMPARATOR

Treatment with Renin Angiotensin system (RAS) blockade or SGLT2i.

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

EXPERIMENTAL

EXPERIMENTAL

Corticotherapy + RAS blockade or SGLT2i treatment. Drug injection (intravenous) + tablets

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

Interventions

corticotherapy DRUG

3 IV pulses steroids followed by oral steroids for 4 months

EXPERIMENTAL

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

treatment with Renin angiotensin system (RAS) blockade or SGLT2i

CONTROL; EXPERIMENTAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years
• Patient with IgAN
• PCR ratio \>0.75 g/g (within 30 days before or after the renal biopsy)
• 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)
• Patient with Social Security Insurance or CMU
• Patient having signed an informed consent

You may not qualify if:

• \>50% cellular/fibrocellular crescents, or \>50% tubulointerstitial fibrosis or \>50% globally sclerotic glomeruli
• Nephrotic syndrome with minimal change disease and IgA deposits
• eGFR \<20 ml/min/1,73m2 (CKD-EPI formula) within 30 days before or after the renal biopsy
• Uncontrolled blood pressure (Systolic blood pressure \>180 mmHg or diastolic blood pressure \> 110 mmHg)
• Previous corticosteroids treatment (\>20 mg/d during more than 15 days, within the last 3 months before the renal biopsy)
• Pregnancy or breast feeding or women without sufficient contraception
• Secondary known forms of IgAN
• Henoch-Schoenlein purpura
• Additional other chronic renal disease
• Contraindication for RAS orSGLT2i blockade therapy
• Known allergy or intolerance to corticoids or lactose
• Organ transplant patient

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker Enfants-malades

Paris, Paris, 75015, France

Location

Related Publications (2)

• Shi S, Roberts ISD, Wang Z, Jiang L, Tang C, Wang J, Lv J, Wong MG, Barbour SJ, Perkovic V, Cattran D, Zhang H; TESTING Study Pathology Group. Predictive Value of the Oxford Classification for the Effect of Glucocorticoid Therapy in IgA Nephropathy. J Am Soc Nephrol. 2025 Jul 8. doi: 10.1681/ASN.0000000796. Online ahead of print. No abstract available.

  PMID: 40627446 DERIVED

• El Karoui K, Fervenza FC, De Vriese AS. Treatment of IgA Nephropathy: A Rapidly Evolving Field. J Am Soc Nephrol. 2024 Jan 1;35(1):103-116. doi: 10.1681/ASN.0000000000000242. Epub 2023 Sep 29.

  PMID: 37772889 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Renin-Angiotensin System

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Metabolism; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Dominique JOLY, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Eric ALAMARTINE

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

• Khalil El Karoui

  Henri Mondor University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: June 16, 2017
• Study Start: February 20, 2018
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2024
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)