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Treatment of IgA Nephropathy According to Renal Lesions (TIGER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03188887
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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 + RAS blockade (versus RAS blockade alone) after two years of evolution in IgAN patients with severe histological lesions The study will include 122 IgAN patients, it is scheduled to start in september 2017.


Condition or disease Intervention/treatment Phase
IgA Nephropathy Drug: corticotherapy Drug: Renin Angiotensin system (RAS) blockade Phase 3

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 RAS blockade 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of IgA Nephropathy According to Renal Lesions
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : February 20, 2022
Estimated Study Completion Date : February 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: CONTROL
Treatment with Renin Angiotensin system (RAS) blockade.
Drug: Renin Angiotensin system (RAS) blockade
treatment with Renin angiotensin system (RAS) blockade

Experimental: EXPERIMENTAL
Corticotherapy + RAS blockade treatment. Drug injection (intravenous) + tablets
Drug: corticotherapy
3 IV pulses steroids followed by oral steroids for 4 months

Drug: Renin Angiotensin system (RAS) blockade
treatment with Renin angiotensin system (RAS) blockade




Primary Outcome Measures :
  1. Failure at 24 months [ Time Frame: Month 24 ]

    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)


Secondary Outcome Measures :
  1. Failure at 6 months [ Time Frame: Month 6 ]

    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

  2. Failure at 12 months [ Time Frame: Month 12 ]

    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)

  3. Proportion of patients with persistent severe histological lesions in repeat kidney biopsy at 12 months [ Time Frame: Month 12 ]
    to compare the evolution of histological lesions between treatment groups at 12 months

  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 [ Time Frame: Month 12 ]
    to compare the evolution of measured GFR (mGFR) between treatment groups at 12 months (or estimated GFR (eGFR) if unavailable)

  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 [ Time Frame: Month 24 ]
    to compare the evolution of measured GFR (mGFR) between treatment groups at 24 months (or estimated GFR (eGFR) if unavailable)

  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 [ Time Frame: Month 12 and 24 ]
    to compare the evolution of proteinuria in each group

  7. SF36 scale at 12 months [ Time Frame: Month 12 ]
    to compare the quality of life in each therapeutic group

  8. SF36 scale at 24 months [ Time Frame: Month 24 ]
    to compare the quality of life in each therapeutic group

  9. Number of side effects [ Time Frame: Month 24 ]
    to assess the tolerance of treatments in each therapeutic group

  10. Prognosis markers of failure at 24 months [ Time Frame: Month 24 ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >= 18 years
  2. IgAN diagnosed on renal biopsy < 45 days
  3. PCR ratio >0.75 g/g (within 30 days before or after the renal biopsy)
  4. 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)
    • ≥10% cellular/fibrocellular crescents.
  5. Patient with Social Security System Insurance
  6. Patient having signed an informed consent

Exclusion Criteria:

  1. >30% increase of serum creatinine within 15 days after starting RAS blockade therapy
  2. >50% cellular/fibrocellular crescents, or >50% tubulointerstitial fibrosis or >50% globally sclerotic glomeruli
  3. >50% plasma creatinine increase within the last 3 months before the renal biopsy
  4. Nephrotic syndrome with minimal change disease and IgA deposits
  5. eGFR <20 ml/min/1,73m2 (CKD-EPI formula) within 30 days before or after the renal biopsy
  6. Uncontrolled blood pressure (Systolic blood pressure >180 mmHg or diastolic blood pressure > 110 mmHg)
  7. Previous corticosteroids treatment (>20 mg/d during more than 15 days, within the last 3 months before the renal biopsy)
  8. Pregnancy or breast feeding or women without sufficient contraception
  9. Secondary known forms of IgAN
  10. Henoch-Schoenlein purpura
  11. Additional other chronic renal disease
  12. 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
  13. Contraindication for RAS blockade therapy
  14. Known allergy or intolerance to corticoids or lactose
  15. Organ transplant patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188887


Contacts
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Contact: Dominique JOLY, MD, PhD +33 1 44 49 54 12 dominique.joly@nck.aphp.fr
Contact: Sandra COLAS 01 71 19 64 32 sandra.colas@aphp.fr

Locations
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France
Hôpital Necker Enfants-malades Recruiting
Paris, France, 75015
Contact: Dominique JOLY, MD, PhD    +33 1 44 49 54 12    dominique.joly@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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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 Hospital
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03188887    
Other Study ID Numbers: P140931
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
NIgA
Kidney biopsy
GFR
Corticotherapy
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases