- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03188887
Treatment of IgA Nephropathy According to Renal Lesions (TIGER)
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Paris, France, 75015
- Hôpital Necker Enfants-Malades
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- >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)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CONTROL
Treatment with Renin Angiotensin system (RAS) blockade or SGLT2i.
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Drug: Renin Angiotensin system (RAS) blockade or Inhibitors of sodium glucose transporter 2 (SGLT2i)
treatment with Renin angiotensin system (RAS) blockade or SGLT2i
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Experimental: EXPERIMENTAL
Corticotherapy + RAS blockade or SGLT2i treatment.
Drug injection (intravenous) + tablets
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Drug: Renin Angiotensin system (RAS) blockade or Inhibitors of sodium glucose transporter 2 (SGLT2i)
treatment with Renin angiotensin system (RAS) blockade or SGLT2i
3 IV pulses steroids followed by oral steroids for 4 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Failure at 24 months
Time Frame: Month 24
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Failure at 24 months will be defined as :
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Month 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Failure at 6 months
Time Frame: Month 6
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Failure at 6 months will be defined as:
|
Month 6
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Failure at 12 months
Time Frame: Month 12
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Failure at 12 months will be defined as:
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Month 12
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Proportion of patients with persistent severe histological lesions in repeat kidney biopsy at 12 months
Time Frame: Month 12
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to compare the evolution of histological lesions between treatment groups at 12 months
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Month 12
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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
|
to compare the evolution of measured GFR (mGFR) between treatment groups at 12 months (or estimated GFR (eGFR) if unavailable)
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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
|
to compare the evolution of measured GFR (mGFR) between treatment groups at 24 months (or estimated GFR (eGFR) if unavailable)
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Month 24
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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
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to compare the evolution of proteinuria in each group
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Month 12 and 24
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SF36 scale at 12 months
Time Frame: Month 12
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to compare the quality of life in each therapeutic group
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Month 12
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SF36 scale at 24 months
Time Frame: Month 24
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to compare the quality of life in each therapeutic group
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Month 24
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Number of side effects
Time Frame: Month 24
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to assess the tolerance of treatments in each therapeutic group
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Month 24
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Prognosis markers of failure at 24 months
Time Frame: Month 24
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Clinical, histological, and biological data (including PCR ratio, eGFR and mGFR, renal histological lesions) will be compared between patients with or without failure.
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Month 24
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dominique JOLY, MD, PhD, Assistance Publique - Hôpitaux de Paris
- Principal Investigator: Eric ALAMARTINE, CHU Saint-etienne
- Study Chair: Khalil El Karoui, Henri Mondor University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P140931
- 2016-004507-31 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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