Steroids Therapy in IgA Nephropathy With Crescents

Last updated: June 2, 2021
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

3

Condition

Nephritis

Kidney Disease

Glomerulonephritis

Treatment

N/A

Clinical Study ID

NCT04833374
1010PY (2020) -51
  • Ages 14-65
  • All Genders

Study Summary

This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of steroids therapy for patients of IgA nephropathy with crescents.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 14~65 years, regardless of gender
  2. Clinical evaluation and renal biopsy diagnostic for IgA nephropathy, presenting withcrescents.
  3. Average urinary protein excretion of 0.3~3.5g/24h on two successive examinations.
  4. eGFR≥30 ml/min/1.73m2.
  5. Willingness to sign an informed consent.

Exclusion

Exclusion Criteria:

  1. Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuricnephritis and hepatitis B-associated nephritis, etc.
  2. Rapidly progressive nephritic syndrome (crescent formation≥50%).
  3. Acute renal failure, including rapidly progressive IgAN.
  4. Current or recent (within 30 days) exposure to high-dose of steroids orimmunosuppressive therapy (CTX、MMF、CsA、FK506).
  5. Date of renal biopsy exceeds more than 30 days.
  6. Cirrhosis, chronic active liver disease, and serious liver function damage.
  7. History of significant gastrointestinal disorders (e.g. severe chronic diarrhea oractive peptic ulcer disease).
  8. Any Active systemic infection or history of serious infection within one month.
  9. Other major organ system disease (e.g. serious cardiovascular diseases includingcongestive heart failure , chronic obstructive pulmonary disease, asthma requiringoral steroid treatment or central nervous system diseases).
  10. Active tuberculosis
  11. Malignant hypertension that is difficult to be controlled by oral drugs.
  12. Known allergy, contraindication or intolerance to the steroids.
  13. Pregnancy or breast feeding at the time of entry or unwillingness to comply withmeasures for contraception.
  14. Malignant tumors.
  15. Excessive drinking or drug abuse.
  16. Mental aberrations.
  17. Current or recent (within 30 days) exposure to any other investigational drugs.
  18. Current use of RAS inhibitors needs to be eluted for at least 1 week beforeparticipating in the study.

Study Design

Total Participants: 200
Study Start date:
May 24, 2021
Estimated Completion Date:
December 31, 2023

Study Description

It has been reported that for urinary protein excretion that is persistently more than 1g/24h and eGFR>50ml/min/1.73m2 in IgA nephropathy(IgAN), the KDIGO guidelines suggest a 6-month course of glucocorticoids. The famous study by Pozzi C has proved that for patients of IgAN with proteinuria of 1.0-3.5g/24h and serum creatinine concentrations of 133 umol/L or less, a 6-month course of steroid treatment(1g/d methylprednisolone intravenously for 3 consecutive days, with the course repeated 2 months and 4 months later,then oral prednisone 0.5mg/kg/d on alternate days for 6 months) could significantly reduce proteinuria and protect against renal function deterioration in IgAN. However, according to Oxford classification, crescents in IgAN would effect the prognosis.This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd month ,then oral prednisone 0.5mg/kg/d on alternate days. Patients in control group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-3rd-5th month ,then oral prednisone 0.5mg/kg/d on alternate days. After followed-up for 6 months, the curative effect of steroid therapy on proteinuria and the progression of IgAN will be evaluated.

Connect with a study center

  • Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510655
    China

    Active - Recruiting

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