Status:
UNKNOWN
Leflunomide Plus Low Dose Corticosteroid in Immunoglobulin A (IgA) Nephropathy With Renal Insufficiency
Lead Sponsor:
Shenzhen Second People's Hospital
Conditions:
Glomerulonephritis, IGA
Renal Insufficiency, Chronic
Eligibility:
All Genders
14-65 years
Phase:
PHASE4
Brief Summary
IgA nephropathy is the most common primary glomerulonephritis in the world. Because of the poor treatment effect in advanced patients, it is still the main cause of maintenance dialysis. Current immun...
Detailed Description
all the participants enrolled in the study will be randomly assigned in a 1:1 ratio, the experimental group will receive leflunomide + low dose glucocorticoids therapy on the basis of conservative tre...
Eligibility Criteria
Inclusion
- 14 to 65 years old participants, No restrictions on gender or race
- Diagnosis of primary IgA nephropathy
- Renal biopsy within 6 months before screening. Renal pathology shows diffuse IgA deposition in the Mesangial area and dense deposition in the Mesangial area under electron microscope. glomeruli more than 8
- persistent proteinuria ≥ 1 g/24 hr (or urine protein/creatinine ratio ≥ 1.0 mg/g), eGFR at 25-50 ml/min/1.73 m2 (calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)
- signed written consent; patients under 18 years old need to have legal guardians to sign informed consent at the same time
Exclusion
- Secondary IgA nephropathy (such as lupus nephritis, Henoch-Schönlein purpura, hepatitis B associated glomerulonephritis, hepatitis C associated glomerulonephritis, liver cirrhosis and other autoimmune diseases)
- eGFR \< 25 ml/min/1.73m2 or eGFR \> 50 ml/min/1.73m2 (calculated by CKD-EPI formula)
- Special types of IgA nephropathy need to be excluded, such as crescent IgA glomerulonephritis (defined as the presence of crescents in over 50% of the glomeruli), or minimal lesions with IgA deposition
- Acute kidney injury within 3 months before screening
- Received immunosuppressive therapy within 3 months before screening
- Patients who had acute or chronic infections that need treatment, and the researchers judged that they were not suitable for inclusion in the study
- Pregnancy, lactation or unreliable birth control
- Dialysis treatment before screening
- Allergic or taboo to planned drugs (such as leflunomide, glucocorticoids, etc.)
- Severe acute or chronic diseases that the researchers believe may bring an excessive risk to the subjects
- A history of malignant tumors within 5 years, with the exception of carcinoma in situ and papillary thyroid carcinoma which have been adequately treated
- Participated in other clinical trials and / or used other research drugs within 4 weeks prior to screening
Key Trial Info
Start Date :
September 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04020328
Start Date
September 12 2019
End Date
May 31 2022
Last Update
February 18 2020
Active Locations (1)
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1
Xu Yi
Shenzhen, Guangdong, China, 518000