Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multicentre Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy. (CLIgAN)

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: NCT04662723
Recruitment Status : Not yet recruiting
First Posted : December 10, 2020
Last Update Posted : October 14, 2021
Sponsor:
Collaborator:
University of Bari
Information provided by (Responsible Party):
Francesco Paolo Schena, Fondazione Schena

Brief Summary:

Idiopathic immunoglobulin A nephropathy (IgAN) is the most common biopsy-proven glomerulonephritis in the world. Approximately 40% of IgAN patients reach end-stage kidney disease (ESKD) 20 years after their kidney biopsy. The high prevalence of ESKD suggests the need to move from a generalized therapy for all patients to personalized therapy.

Many RCTs have been conducted stratifying patients based on the laboratory findings (serum creatinine, eGFR and daily proteinuria). In contrast, data from the kidney biopsy has been used only for clinical diagnosis. Therefore, IgAN patients with acute and/or chronic renal lesions have been equally distributed in experimental and control arms of the randomized clinical trials (RCTs) The clinical study of IgAN (CLIgAN) is a multicentre, prospective, controlled and open-label randomized clinical trial based on patients' stratification at the time of their kidney biopsy. The investigators will consider, first, the type of renal lesions followed by the serum creatinine values, eGFR and proteinuria. IgAN patients with active renal lesions (n=132) will be enrolled in the first RCT (ACIgAN) in which they will receive corticosteroids combined with RASB or only RASB. IgAN patients with chronic renal lesions (n=294) will be enrolled in the second RCT (CHRONIgAN) in which they will receive the SGLT2 inhibitor combined with RASB compared with RASB alone. Using this approach, the investigators hypothesize that patients could receive personalized therapy based on renal lesions to ensure that the right drug gets to the right patient at the right time.

Recently, we developed a Clinical Decision Support System (CDSS) tool using artificial intelligence (artificial neural networks) to identify IgAN patients at high risk of developing ESKD. The IgAN tool was validated in a retrospective cohort of IgAN patients but not in a prospective clinical study. The investigators propose to measure the power of the CDSS tool in patients enrolled in both RCTs to determine whether personalized therapy can slow the decline of the renal function to delay the ESKD.

The CLIgAN study also includes a cutting-edge molecular study for precision therapy (PRECIgAN).


Condition or disease Intervention/treatment Phase
Glomerulonephritis Immunoglobulin A Nephropathy Drug: Corticosteroid Drug: Renin-angiotensin sytem blockers Drug: Sodium-glucose cotransporter 2 inhibitor Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 878 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After the enrolment the eligible biopsy-proven IgAN patients will be randomized, separately, in each trial in a 1 to 1 ratio via a web-based program generating random numbers. The allocation will be not blinded to the group of assignment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentre Prospective Open Label Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy.
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Corticosteroids combined with RASBs
Patients assigned to the corticosteroid group will receive (pulse) methylprednisolone succinate 500-1000 mg/day for 3 consecutive days followed by oral prednisolone (0.5 mg/kg/bw) on alternate days until the end of month. This treatment will be repeated for three consecutive months. In addition, patients will receive RASBs that will be titrated to their maximum anti-proteinuric effect. The dose of methylprednisolone succinate will be individualized (15 mg/kg) based on the ideal body weight. In overweight and obese IgAN patients the ideal body weight will be considered. The drug will be administered in a single daily dose intravenously for 30-60 min. To avoid obesity and diabetes corticosteroids will be administered only in the morning.
Drug: Corticosteroid
To reduce the progression of renal damage in IgAN Patients
Other Names:
  • Methylprednisolone succinate
  • prednisolone

Drug: Renin-angiotensin sytem blockers
To reduce the progression of renal damage in IgAN Patients
Other Names:
  • Ramipril
  • lisinopril
  • losartan

Active Comparator: RASBs
Patients will receive RASBs alone that will be titrated to their maximum anti-proteinuric effect.
Drug: Renin-angiotensin sytem blockers
To reduce the progression of renal damage in IgAN Patients
Other Names:
  • Ramipril
  • lisinopril
  • losartan

Experimental: SGLT2i combined with Ramipril
IgAN patients with chronic renal lesions (T1,2) or moderate renal lesions (M0,1; S0,1; T0; E0; C0) at high or very high CKD risk (proteinuria> 0.5 g/day and GFR >30ml/min/1.73 m2) will receive SGLT2i combined with RASBs.
Drug: Renin-angiotensin sytem blockers
To reduce the progression of renal damage in IgAN Patients
Other Names:
  • Ramipril
  • lisinopril
  • losartan

Drug: Sodium-glucose cotransporter 2 inhibitor
To reduce the progression of renal damage in IgAN Patients
Other Names:
  • dapagliflozin
  • canagliflozin
  • empagliflozin

Active Comparator: Ramipril
IgAN patients with chronic renal lesions (T1,2) or moderate renal lesions (M0,1; S0,1; T0; E0; C0) at high or very high CKD risk (proteinuria> 0.5 g/day and GFR >30ml/min/1.73 m2) will receive RASBs alone.
Drug: Renin-angiotensin sytem blockers
To reduce the progression of renal damage in IgAN Patients
Other Names:
  • Ramipril
  • lisinopril
  • losartan




Primary Outcome Measures :
  1. -Proteinuria reduction within 6 months in IgAN patients with active renal lesions [ Time Frame: 6th month ]
    Reduction of proteinuria will be calculated as difference betweeen arms within 6 months

  2. Proteinuria reduction within 6 months in IgAN patients with active renal lesions [ Time Frame: 12th month ]
    Reduction of proteinuria will be calculated as difference betweeen arms within every 6 months

  3. Proteinuria reduction within 6 months in IgAN patients with active renal lesions [ Time Frame: 18th month ]
    Reduction of proteinuria will be calculated as difference betweeen arms within every 6 months

  4. Proteinuria reduction within 6 months in IgAN patients with active renal lesions [ Time Frame: 24th month ]
    Reduction of proteinuria will be calculated as difference betweeen arms within every 6 months

  5. Proteinuria reduction within 6 months in IgAN patients with active renal lesions [ Time Frame: 30th month ]
    Reduction of proteinuria will be calculated as difference betweeen arms within every 6 months

  6. Proteinuria reduction within 6 months in IgAN patients with active renal lesions [ Time Frame: 36th month ]
    Reduction of proteinuria will be calculated as difference betweeen arms within every 6 months

  7. Proteinuria reduction within 6 months in IgAN patients with chronic renal lesions [ Time Frame: 6th month ]
    Reduction of proteinuria will be calculated as difference betweeen arms within every 6 months

  8. Proteinuria reduction within 6 months in IgAN patients with chronic renal lesions [ Time Frame: 12th month ]
    Reduction of proteinuria will be calculated as difference betweeen arms within every 6 months

  9. Proteinuria reduction within 6 months in IgAN with chronic renal lesions [ Time Frame: 18th month ]
    Reduction of proteinuria will be calculated as difference betweeen arms within every 6 months

  10. Proteinuria reduction within 6 months in IgAN patients with chronic renal lesions [ Time Frame: 24th month ]
    Reduction of proteinuria will be calculated as difference betweeen arms within every 6 months

  11. Proteinuria reduction within 6 months in IgAN with chronic renal lesions [ Time Frame: 30th month ]
    Reduction of proteinuria will be calculated as difference betweeen arms within every 6 months

  12. Proteinuria reduction within 6 months in IgAN with chronic renal lesions [ Time Frame: 36th month ]
    Reduction of proteinuria will be calculated as difference betweeen arms within every 6 months


Secondary Outcome Measures :
  1. eGFR slope change in IgAN patients with active renal lesions [ Time Frame: 6th month ]
    eGFR slope change calculated as the mean of the individual slopes obtained from individual linear regression of eGFR over time;

  2. eGFR slope change in IgAN patients with active renal lesions [ Time Frame: 12th month ]
    eGFR slope change calculated as the mean of the individual slopes obtained from individual linear regression of eGFR over time;

  3. eGFR slope change in IgAN patients with active renal lesions [ Time Frame: 18th month ]
    eGFR slope change calculated as the mean of the individual slopes obtained from individual linear regression of eGFR over time;

  4. eGFR slope change in IgAN patients with active renal lesions [ Time Frame: 24th month ]
    eGFR slope change calculated as the mean of the individual slopes obtained from individual linear regression of eGFR over time;

  5. eGFR slope change in IgAN patients with active renal lesions [ Time Frame: 30th month ]
    eGFR slope change calculated as the mean of the individual slopes obtained from individual linear regression of eGFR over time;

  6. eGFR slope change in IgAN patients with active renal lesions [ Time Frame: 36th month ]
    eGFR slope change calculated as the mean of the individual slopes obtained from individual linear regression of eGFR over time;

  7. eGFR slope change in IgAN patients with chronic renal lesions [ Time Frame: 6th month ]
    eGFR slope change calculated as the mean of the individual slopes obtained from individual linear regression of eGFR over time;

  8. eGFR slope change in IgAN patients with chronic renal lesions [ Time Frame: 12th month ]
    eGFR slope change calculated as the mean of the individual slopes obtained from individual linear regression of eGFR over time;

  9. eGFR slope change in IgAN patients with chronic renal lesions [ Time Frame: 18th month ]
    eGFR slope change calculated as the mean of the individual slopes obtained from individual linear regression of eGFR over time;

  10. eGFR slope change in IgAN patients with chronic renal lesions [ Time Frame: 24th month ]
    eGFR slope change calculated as the mean of the individual slopes obtained from individual linear regression of eGFR over time;

  11. eGFR slope change in IgAN patients with chronic renal lesions [ Time Frame: 30th month ]
    eGFR slope change calculated as the mean of the individual slopes obtained from individual linear regression of eGFR over time;

  12. eGFR slope change in IgAN patients with chronic renal lesions [ Time Frame: 36th month ]
    eGFR slope change calculated as the mean of the individual slopes obtained from individual linear regression of eGFR over time;

  13. eGFR decline >40% in IgAN patients with active renal lesions [ Time Frame: 6th month ]
    eGFR decline >40% in IgAN patients with active renal lesions

  14. eGFR decline >40% in IgAN patients with active renal lesions [ Time Frame: 12th month ]
    eGFR decline >40% in IgAN patients with active renal lesions

  15. eGFR decline >40% in IgAN patients with active renal lesions [ Time Frame: 18th month ]
    eGFR decline >40% in IgAN patients with active renal lesions

  16. eGFR decline >40% in IgAN patients with active renal lesions [ Time Frame: 24th month ]
    eGFR decline >40% in IgAN patients with active renal lesions

  17. eGFR decline >40% in IgAN patients with active renal lesions [ Time Frame: 30th month ]
    eGFR decline >40% in IgAN patients with active renal lesions

  18. eGFR decline >40% in IgAN patients with active renal lesions [ Time Frame: 36th month ]
    eGFR decline >40% in IgAN patients with active renal lesions

  19. eGFR decline >40% in IgAN patients with chronic renal lesions [ Time Frame: 6th month ]
    eGFR decline >40% in IgAN patients with chronic renal lesions

  20. eGFR decline >40% in IgAN patients with chronic renal lesions [ Time Frame: 12th month ]
    eGFR decline >40% in IgAN patients with chronic renal lesions

  21. eGFR decline >40% in IgAN patients with chronic renal lesions [ Time Frame: 18th month ]
    eGFR decline >40% in IgAN patients with chronic renal lesions

  22. eGFR decline >40% in IgAN patients with chronic renal lesions [ Time Frame: 24th month ]
    eGFR decline >40% in IgAN patients with chronic renal lesions

  23. eGFR decline >40% in IgAN patients with chronic renal lesions [ Time Frame: 30th month ]
    eGFR decline >40% in IgAN patients with chronic renal lesions

  24. eGFR decline >40% in IgAN patients with chronic renal lesions [ Time Frame: 36th month ]
    eGFR decline >40% in IgAN patients with chronic renal lesions

  25. composite endpoint: eGFR decline > 40%, ESKD (defined as long-term eGFR < 15 ml/min/1.73m2 for more than 3 months or need of maintenance dialysis or kidney transplantation) and death due to kidney disease in IgAN patients with active renal lesions [ Time Frame: 6th month ]
    composite endpoint: eGFR decline > 40%, ESKD (defined as long-term eGFR < 15 ml/min/1.73m2 for more than 3 months or need of maintenance dialysis or kidney transplantation) and death due to kidney disease in IgAN patients with active renal lesions

  26. composite endpoint: eGFR decline > 40%, ESKD (defined as long-term eGFR < 15 ml/min/1.73m2 for more than 3 months or need of maintenance dialysis or kidney transplantation) and death due to kidney disease in IgAN patients with active renal lesions [ Time Frame: 12th month ]
    composite endpoint: eGFR decline > 40%, ESKD (defined as long-term eGFR < 15 ml/min/1.73m2 for more than 3 months or need of maintenance dialysis or kidney transplantation) and death due to kidney disease in IgAN patients with active renal lesions

  27. composite endpoint: eGFR decline > 40%, ESKD (defined as long-term eGFR < 15 ml/min/1.73m2 for more than 3 months or need of maintenance dialysis or kidney transplantation) and death due to kidney disease in IgAN patients with active renal lesions [ Time Frame: 18th month ]
    composite endpoint: eGFR decline > 40%, ESKD (defined as long-term eGFR < 15 ml/min/1.73m2 for more than 3 months or need of maintenance dialysis or kidney transplantation) and death due to kidney disease in IgAN patients with active renal lesions

  28. composite endpoint: eGFR decline > 40%, ESKD and death due to kidney disease in IgAN patients with active renal lesions [ Time Frame: 24th month ]
    composite endpoint: eGFR decline > 40%, ESKD (defined as long-term eGFR < 15 ml/min/1.73m2 for more than 3 months or need of maintenance dialysis or kidney transplantation) and death due to kidney disease in IgAN patients with active renal lesions

  29. composite endpoint: eGFR decline > 40%, ESKD and death due to kidney disease in IgAN patients with active renal lesions [ Time Frame: 30th month ]
    composite endpoint: eGFR decline > 40%, ESKD (defined as long-term eGFR < 15 ml/min/1.73m2 for more than 3 months or need of maintenance dialysis or kidney transplantation) and death due to kidney disease in IgAN patients with active renal lesions

  30. composite endpoint: eGFR decline > 40%, ESKD and death due to kidney disease in IgAN patients with active renal lesions [ Time Frame: 36th month ]
    composite endpoint: eGFR decline > 40%, ESKD (defined as long-term eGFR < 15 ml/min/1.73m2 for more than 3 months or need of maintenance dialysis or kidney transplantation) and death due to kidney disease in IgAN patients with active renal lesions

  31. composite endpoint: eGFR decline > 40%, ESKD and death due to kidney disease in IgAN patients with chronic renal lesions [ Time Frame: 6th month ]
    composite endpoint: eGFR decline > 40%, ESKD (defined as long-term eGFR < 15 ml/min/1.73m2 for more than 3 months or need of maintenance dialysis or kidney transplantation) and death due to kidney disease in IgAN patients with chronic rena lesions

  32. composite endpoint: eGFR decline > 40%, ESKD and death due to kidney disease in IgAN patients with chronic renal lesions [ Time Frame: 12th month ]
    composite endpoint: eGFR decline > 40%, ESKD (defined as long-term eGFR < 15 ml/min/1.73m2 for more than 3 months or need of maintenance dialysis or kidney transplantation) and death due to kidney disease in IgAN patients with chronic rena lesions

  33. composite endpoint: eGFR decline > 40%, ESKD and death due to kidney disease. in IgAN patients with chronic renal lesions [ Time Frame: 18th month ]
    composite endpoint: eGFR decline > 40%, ESKD (defined as long-term eGFR < 15 ml/min/1.73m2 for more than 3 months or need of maintenance dialysis or kidney transplantation) and death due to kidney disease in IgAN patients with chronic renal lesions

  34. composite endpoint: eGFR decline > 40%, ESKD and death due to kidney disease. in IgAN patients with chronic renal lesions [ Time Frame: 24th month ]
    composite endpoint: eGFR decline > 40%, ESKD (defined as long-term eGFR < 15 ml/min/1.73m2 for more than 3 months or need of maintenance dialysis or kidney transplantation) and death due to kidney disease in IgAN patients with chronic renal lesions

  35. composite endpoint: eGFR decline > 40%, ESKD and death due to kidney disease. in IgAN patients with chronic renal lesions [ Time Frame: 30th month ]
    composite endpoint: eGFR decline > 40%, ESKD (defined as long-term eGFR < 15 ml/min/1.73m2 for more than 3 months or need of maintenance dialysis or kidney transplantation) and death due to kidney disease in IgAN patients with chronic renal lesions

  36. composite endpoint: eGFR decline > 40%, ESKD and death due to kidney disease. in IgAN patients with chronic renal lesions [ Time Frame: 36th month ]
    composite endpoint: eGFR decline > 40%, ESKD (defined as long-term eGFR < 15 ml/min/1.73m2 for more than 3 months or need of maintenance dialysis or kidney transplantation) and death due to kidney disease in IgAN patients with chronic renal lesions

  37. proteinuria reduction (geometric mean of 30% within 6 months) [ Time Frame: 6th month ]
    proteinuria reduction in IgAN patients with chronic renal lesions

  38. proteinuria reduction (geometric mean of 30% within 6 months) [ Time Frame: 12th month ]
    proteinuria reduction in IgAN patients with chronic renal lesions

  39. proteinuria reduction (geometric mean of 30% within 6 months) [ Time Frame: 18th month ]
    proteinuria reduction in IgAN patients with chronic renal lesions

  40. proteinuria reduction (geometric mean of 30% within 6 months) [ Time Frame: 24th month ]
    proteinuria reduction in IgAN patients with chronic renal lesions

  41. proteinuria reduction (geometric mean of 30% within 6 months) [ Time Frame: 30th month ]
    proteinuria reduction in IgAN patients with chronic renal lesions

  42. proteinuria reduction (geometric mean of 30% within 6 months) [ Time Frame: 36th month ]
    proteinuria reduction in IgAN patients with chronic renal lesions

  43. time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement in IgAN patients with active renal lesions [ Time Frame: 3rd month ]
    time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement

  44. time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement in IgAN patients with active renal lesions [ Time Frame: 6th month ]
    time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement

  45. time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement in IgAN patients with active renal lesions [ Time Frame: 9th month ]
    time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement

  46. time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement in IgAN patients with active renal lesions [ Time Frame: 12th month ]
    time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement

  47. time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement in IgAN patients with active renal lesions [ Time Frame: 18th month ]
    time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement

  48. time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement in IgAN patients with active renal lesions [ Time Frame: 24th month ]
    time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement

  49. time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement in IgAN patients with active renal lesions [ Time Frame: 30th month ]
    time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement

  50. time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement in IgAN patients with active renal lesions [ Time Frame: 36th month ]
    time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement

  51. time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement in IgAN patients with chronic renal lesions [ Time Frame: 6th month ]
    time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement

  52. time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement in IgAN patients with chronic renal lesions [ Time Frame: 12th month ]
    time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement

  53. time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement in IgAN patients with chronic renal lesions [ Time Frame: 18th month ]
    time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement

  54. time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement in IgAN patients with chronic renal lesions [ Time Frame: 24th month ]
    time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement

  55. time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement in IgAN patients with chronic renal lesions [ Time Frame: 30th month ]
    time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement

  56. time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement in IgAN patients with chronic renal lesions [ Time Frame: 36 th month ]
    time-averaged proteinuria (TA-P) calculated as the weighted mean of all post-randomization measurement, with weights representing the time elapsed since the previous measurement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Only adult patients (age 18-70 years) with biopsy-proven idiopathic IgAN.
  • IgAN patients with active or chronic or moderate renal lesions

Exclusion Criteria

  • Patients with idiopathic IgAN and nephrotic syndrome (minimal change disease at kidney biopsy)
  • IgAN patients with hematuria and acute renal failure
  • IgAN patients with rapidly progressive glomerulonephritis (extracapillary lesions in more than 50% of glomeruli)
  • Patients with secondary IgAN (lupus nephritis, Schoenlein-Henoch purpura, liver cirrhosis)
  • Any prior immunosuppressive therapy
  • Superimposed IgAN in kidney transplant
  • Severe liver diseases
  • Infections
  • Malignancies
  • Pregnancy
  • Patients with myocardial infarction or cerebrovascular stroke in the previous 6 months
  • Uncontrolled diabetes
  • Aseptic necrosis of any bone
  • Other conditions that can be exacerbated by corticosteroids
  • Previous adverse side effects to RASBs
  • Previous adverse side effects to SGLT2is
  • Patients with mild renal lesions (M0,E0,S0,T0,C0), minor urinary findings, proteinuria < 0.5 g/day, normal GFR and normal blood pressure

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): NCT04662723


Contacts
Layout table for location contacts
Contact: Francesco P Schena 39 3336771291 paolo.schena@uniba.it

Sponsors and Collaborators
Fondazione Schena
University of Bari
Investigators
Layout table for investigator information
Principal Investigator: Francesco P Schena Fondazione Schena
Publications of Results:

Layout table for additonal information
Responsible Party: Francesco Paolo Schena, President and scientif director, Fondazione Schena
ClinicalTrials.gov Identifier: NCT04662723    
Other Study ID Numbers: 2
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared with other partners
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Six years
Access Criteria: Publications or reports
URL: http://www.fondazioneschena.org

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Francesco Paolo Schena, Fondazione Schena:
IgA nephropathy
Steroids
RAS-blockers
SGLT2-inhibitors
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Glomerulonephritis
Glomerulonephritis, IGA
Urologic Diseases
Nephritis
Autoimmune Diseases
Immune System Diseases
Dapagliflozin
Empagliflozin
Canagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Losartan
Ramipril
Lisinopril
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists