NCT03188887CompletedPhase 3
Treatment of IgA Nephropathy According to Renal Lesions
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 2 May 2017
- Start date
- 20 Feb 2018
- Primary completion date
- 12 Jan 2024
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- IgA nephropathy
- NCT number
- NCT03188887
- EudraCT number
- 2016-004507-31
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 62
- From 20 Feb 2018 to the primary completion date, 12 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous corticosteroids treatment (\>20 mg/d during more than 15 days, within the last 3 months before the renal biopsy)
- Contraindication for RAS orSGLT2i blockade therapy
- Organ transplant patient
Other illness
- Nephrotic syndrome with minimal change disease and IgA deposits
- Additional other chronic renal disease
- 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
- Known allergy or intolerance to corticoids or lactose
Lab values
- \>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
- eGFR \<20 ml/min/1,73m2 (CKD-EPI formula) within 30 days before or after the renal biopsy
Other
- \>50% cellular/fibrocellular crescents, or \>50% tubulointerstitial fibrosis or \>50% globally sclerotic glomeruli
- Uncontrolled blood pressure (Systolic blood pressure \>180 mmHg or diastolic blood pressure \> 110 mmHg)
- Pregnancy or breast feeding or women without sufficient contraception
- Secondary known forms of IgAN
- Henoch-Schoenlein purpura
Who the study is looking for
- Age \>= 18 years
- Patient with IgAN
- Renal biopsy \< 45 days before inclusion visit
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.