Status:
UNKNOWN
Beginning of Effective and Safe Treatment in Immunoglobulin A-1 Nephropathy-1
Lead Sponsor:
Ewha Womans University
Collaborating Sponsors:
The Catholic University of Korea
Kyung Hee University Hospital at Gangdong
Conditions:
Glomerulonephritis, Immunoglobulin A (IgA)
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
Immunoglobulin A nephropathy (IgAN) is the most common glomerulonephritis worldwide. IgAN is progressive, particularly when patients have a significant proteinuria (proteinuria \>1g/g creatinine), imp...
Eligibility Criteria
Inclusion
- Biopsy-proven IgAN: dominant or co-dominant deposits of mesangial IgA in immunofluorescence stain
- Age \>= 19 years
- Random urine protein-to-creatinine ratio 0.3 g/g creatinine to 1.0 g/g creatinine at visit 1
- Estimated glomerular filtration rate \>= 60 mL/min/1.73m2 at visit 1
- People who voluntarily agreed to participate
- People who are compliant
Exclusion
- Prevalent Hypertension: systolic blood pressure \>=140 mmHg and \>=90 mmHg, previous physician diagnosis of hypertension, or taking anti-hypertensive drugs
- Prevalent Diabetes: fasting glucose \>= 126 mg/dL, HbA1c \>= 6.5%, taking insulin or anti-diabetic drugs, or previous physician diagnosis of diabetes
- Previous immunosuppressive drugs use to treat IgAN
- Secondary IgAN
- Renin-angiotensin-aldosterone inhibitors (RASI) dependent patients (congestive heart failure, ischemic heart disease, and others)
- hypersensitivity to RASI
- Other chronic diseases: malignancy within 5 years, significant liver and gastrointestinal disease and other autoimmune disease
- Pregnancy
- symptomatic orthostatic hypotension
- People who already participated in other interventional studies or taking interventional drugs within 3 month of screening visit
- Inappropriate people ascertained by investigator
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT03357653
Start Date
January 30 2018
End Date
December 31 2021
Last Update
November 30 2017
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