Status:
UNKNOWN
Effect of Immunosuppression in IgA Nephropathy
Lead Sponsor:
Yonsei University
Conditions:
Biopsy-proven IgA Nephropathy
Eligibility:
All Genders
19-75 years
Phase:
PHASE4
Brief Summary
IgA nephropathy (IgAN) is the most common glomerulonephritis worldwide, leading to end stage renal disease (ESRD) in up to 30 to 40% of patients with in a few decades after diagnosis. Several therapeu...
Detailed Description
The investigators will conduct a multicenter prospective randomized controlled open-label trial; a step-wise therapeutic approach in IgAN patients with persistent proteinuria who have preserved eGFR o...
Eligibility Criteria
Inclusion
- Biopsy-proven IgA nephropathy within 5 years of enrollment
- Persistent proteinuria of UPCR ≥ 1.0 g/g creatinine during 12-week supportive care including RAS blockers
- baseline eGFR ≥ 30 ml/min/1.73 m2 assessed by CKD-EPI equation
Exclusion
- Nephrotic syndrome, atypical IgA nephropathy
- Crescents ≥ 25%
- Overt pulmonary tuberculosis
- Malignancy within 5 years of enrollment
- Pregnancy or breast feeding
- Active hepatitis, chronic hepatitis, liver cirrhosis, HIV
- Kidney transplant
- Current use of immunosuppressive treatment or prior use of immunosuppressive drugs within 1 year of enrollment
- Uncontrolled hypertension (\> 160/100 mmHg)
- Aged \< 19 years
- Secondary IgA nephropathy such as lupus nephritis, chronic liver disease, or Henoch-Schlein purpura
- Involvement of other clinical trials within 3 months of enrollment
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT03468972
Start Date
March 1 2019
End Date
May 1 2023
Last Update
February 8 2019
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea, 03722