Leflunomide Plus Low Dose Corticosteroid in Immunoglobulin A (IgA) Nephropathy With Renal Insufficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04020328
• Date of registration: 10/07/2019
• Prospective Registration: Yes
• Primary sponsor: Shenzhen Second People's Hospital
• Public title: Leflunomide Plus Low Dose Corticosteroid in Immunoglobulin A (IgA) Nephropathy With Renal Insufficiency
• Scientific title: A Randomized, Controlled Trial to Evaluate Leflunomide Plus Low Dose Corticosteroid Therapy in Progressive IgA Nephropathy With Renal Insufficiency
• Date of first enrolment: September 12, 2019
• Target sample size: 70
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04020328
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: Yi Xu

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 14 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Glomerulonephritis, IGA

Renal Insufficiency, Chronic

Intervention(s)

Drug: Leflunomide 20 mg+prednisone 0.5mg/kg/d

Primary Outcome(s)

renal survival rate [Time Frame: at least 96 weeks]

Secondary Outcome(s)

partial remission rate [Time Frame: at least 96 weeks]

complete remission rate [Time Frame: at least 96 weeks]

eGFR [Time Frame: at least 96 weeks]

proteinuria [Time Frame: at least 96 weeks]

no response rate [Time Frame: at least 96 weeks]

Secondary ID(s)

20193357002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors