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/AClinical Study ID
NCT04833374
1010PY (2020) -51
Ages 14-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 14~65 years, regardless of gender
- Clinical evaluation and renal biopsy diagnostic for IgA nephropathy, presenting withcrescents.
- Average urinary protein excretion of 0.3~3.5g/24h on two successive examinations.
- eGFR≥30 ml/min/1.73m2.
- Willingness to sign an informed consent.
Exclusion
Exclusion Criteria:
- Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuricnephritis and hepatitis B-associated nephritis, etc.
- Rapidly progressive nephritic syndrome (crescent formation≥50%).
- Acute renal failure, including rapidly progressive IgAN.
- Current or recent (within 30 days) exposure to high-dose of steroids orimmunosuppressive therapy (CTX、MMF、CsA、FK506).
- Date of renal biopsy exceeds more than 30 days.
- Cirrhosis, chronic active liver disease, and serious liver function damage.
- History of significant gastrointestinal disorders (e.g. severe chronic diarrhea oractive peptic ulcer disease).
- Any Active systemic infection or history of serious infection within one month.
- 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).
- Active tuberculosis
- Malignant hypertension that is difficult to be controlled by oral drugs.
- Known allergy, contraindication or intolerance to the steroids.
- Pregnancy or breast feeding at the time of entry or unwillingness to comply withmeasures for contraception.
- Malignant tumors.
- Excessive drinking or drug abuse.
- Mental aberrations.
- Current or recent (within 30 days) exposure to any other investigational drugs.
- 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
Connect with a study center
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510655
ChinaActive - Recruiting
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