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IgA NephropathyPhase 3TIGERNCT03188887

Treatment of IgA Nephropathy According to Renal Lesions

A Phase 3 study testing corticotherapy and Renin Angiotensin system (RAS) blockade or Inhibitors of sodium glucose transporter 2 (SGLT2i) in people with IgA Nephropathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
IgA Nephropathy
What is being tested?
corticotherapy and Renin Angiotensin system (RAS) blockade or Inhibitors of sodium glucose transporter 2 (SGLT2i)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteFrance
Study dates
20 Feb 2018to 12 Jan 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • >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
  • >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)
Show all 14Show fewer
  • Pregnancy or breast feeding or women without sufficient contraception
  • Secondary known forms of IgAN
  • Henoch-Schoenlein purpura
  • 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
  • Contraindication for RAS orSGLT2i blockade therapy
  • Known allergy or intolerance to corticoids or lactose
  • Organ transplant patient

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Necker Enfants-malades

    Paris, Paris, 75015

Other trials in France

About this study

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.

Read the detailed description

Currently, IgAN treatment recommendations are only based on clinico-biological parameters. Steroids therapy appears to have a major role in IgAN treatment, but previous studies evaluating steroids lacked of optimal control group and reproducible evaluation criteria. No prospective study with optimal nephroprotection had included renal pathology in patients selection criteria, although histological evaluation improves patients prognosis prediction. Until now, the lack of a reliable histological classification has precluded the use of histological lesions to evaluate IgAN prognosis and treatment. Given the recently identified major prognostic role of histological lesions in IgAN, we propose to introduce renal pathology to guide the treatment of IgAN in a multicenter study, using currently validated evaluation criteria of chronic kidney disease progression.

Conditions
IgA Nephropathy
Being tested
corticotherapy, Renin Angiotensin system (RAS) blockade or Inhibitors of sodium glucose transporter 2 (SGLT2i)
Keywords
NIgA, Kidney biopsy, GFR, Corticotherapy
Medical subject headings
Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • corticotherapyDrug

    3 IV pulses steroids followed by oral steroids for 4 months

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

    treatment with Renin angiotensin system (RAS) blockade or SGLT2i

Study groups in NCT03188887
Study groupRoleWhat they receive
CONTROLActive comparatorTreatment with Renin Angiotensin system (RAS) blockade or SGLT2i.
Receives: Drug: Renin Angiotensin system (RAS) blockade or Inhibitors of sodium glucose transporter 2 (SGLT2i)
EXPERIMENTALExperimentalCorticotherapy + RAS blockade or SGLT2i treatment. Drug injection (intravenous) + tablets
Receives: Drug: corticotherapy; Drug: Renin Angiotensin system (RAS) blockade or Inhibitors of sodium glucose transporter 2 (SGLT2i)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Month 24

Secondary outcomes (10)

  1. Failure at 6 months

    Failure at 6 months will be defined as:

    • PCR > 0.75 g/g
    • or PCR > 0.5 g/g and >30% of initial PCR
    • or eGFR < 80% of initial eGFR
    • or end stage renal disease (ESRD)
    • or renal transplantation
    • or death

    Measured: Month 6

  2. Failure at 12 months

    Failure at 12 months will be defined as:

    • PCR > 0.75 g/g
    • or PCR > 0.5 g/g and > 30% of initial PCR
    • or mGFR < 80% of initial mGFR (or eGFR if unavailable)
    • or end stage renal disease (ESRD)
    • or renal transplantation
    • or death

    Measured: Month 12

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

    to compare the evolution of histological lesions between treatment groups at 12 months

    Measured: Month 12

  4. 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

    to compare the evolution of measured GFR (mGFR) between treatment groups at 12 months (or estimated GFR (eGFR) if unavailable)

    Measured: Month 12

  5. 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

    to compare the evolution of measured GFR (mGFR) between treatment groups at 24 months (or estimated GFR (eGFR) if unavailable)

    Measured: Month 24

  6. 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

    to compare the evolution of proteinuria in each group

    Measured: Month 12 and 24

  7. SF36 scale at 12 months

    to compare the quality of life in each therapeutic group

    Measured: Month 12

  8. SF36 scale at 24 months

    to compare the quality of life in each therapeutic group

    Measured: Month 24

  9. Number of side effects

    to assess the tolerance of treatments in each therapeutic group

    Measured: Month 24

  10. Prognosis markers of failure at 24 months

    Clinical, histological, and biological data (including PCR ratio, eGFR and mGFR, renal histological lesions) will be compared between patients with or without failure.

    Measured: Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2017
  2. Study start20 Feb 2018
  3. Primary completion12 Jan 2024
  4. Study completion12 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03188887
Sponsor's protocol ID
P140931
Other IDs
2016-004507-31, 2016
Acronym
TIGER
Status last verified
Oct 2025
First submitted
2 May 2017
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. 2026 Jan 1;37(1):150-159. doi: 10.1681/ASN.0000000796. Epub 2025 Jul 8.

    PubMed 40627446

  • 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.

    PubMed 37772889

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing corticotherapy and Renin Angiotensin system (RAS) blockade or Inhibitors of sodium glucose transporter 2 (SGLT2i) in people with IgA Nephropathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Failure at 24 months (time frame: Month 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03188887, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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