Who is sponsoring NCT04020328?

NCT04020328 is sponsored by Shenzhen Second People's Hospital.

What drugs are being tested in NCT04020328?

Interventions in NCT04020328: Leflunomide 20 mg+prednisone 0.5mg/kg/d.

What condition does NCT04020328 study?

NCT04020328 studies Glomerulonephritis, IGA, Renal Insufficiency, Chronic.

Is NCT04020328 still recruiting?

NCT04020328 is currently status unknown. Last updated 18 February 2020.

Last reviewed 2020-02-18 · How we verify

NCT04020328

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 4 Last updated 18 February 2020

What this trial tests

Phase 4 trial testing Leflunomide 20 mg+prednisone 0.5mg/kg/d in Glomerulonephritis, IGA in 70 participants. Status unknown.

Timeline

12 September 2019

Primary endpoint
1 March 2022

31 May 2022

Quick facts

Lead sponsor	Shenzhen Second People's Hospital
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	12 September 2019
Primary completion	1 March 2022
Estimated completion	31 May 2022
Sites	1 location across China

Drugs / interventions tested

Leflunomide 20 mg+prednisone 0.5mg/kg/d — full drug profile →

Conditions studied

Glomerulonephritis, IGA — all drugs for Glomerulonephritis, IGA →
Renal Insufficiency, Chronic — all drugs for Renal Insufficiency, Chronic →

Sponsor

Shenzhen Second People's Hospital

Who can join

Adults 14 to 65, any sex, with Glomerulonephritis, IGA or Renal Insufficiency, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 immunosuppressive therapy is still controversial, especially to those progressive IgA nephropathy with eGFR\<50ml/min. Leflunomide is widely used in the treatment of rheumatic diseases, such as rheumatoid arthritis and lupus nephritis, it's serum concentration will not be affected by renal function, and it also has antiviral effect. There are two randomized controlled trials and a retrospective study suggesting that leflunomide combined with glucocorticoids can effectively control urinary protein compared with glucocorticoids or conservative treatment, but these three studies are not specifically targeted at patients with estimated Glomerular Filtration Rate(eGFR) \< 50ml/min. Investigators will perform a prospective, open-label, randomized, controlled trial to evaluate the efficacy and safety of leflunomide and low dose glucocorticoids therapy in progressive IgA nephropathy with eGFR\<50ml/min

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

IgA Nephropathy: A Chinese Perspective.
Zhang Z, Zhang Y, Zhang H. · · 2022 · cited 16× · PMID 36751266 · DOI 10.1159/000520039
Immunosuppressive therapy for IgA nephropathy in children.
Alladin A, Hahn D, Hodson EM, Ravani P, et al · · 2024 · cited 5× · PMID 38864363 · DOI 10.1002/14651858.cd015060.pub2

Verify or expand the search:

Other recruiting trials for Glomerulonephritis, IGA

Currently open trials in the same condition.

NCT06858319 — Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy. · Phase 3 · recruiting
NCT06797518 — Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN · Phase 2 · recruiting
NCT04663204 — A Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropath · Phase 2 · active not recruiting

Other Shenzhen Second People's Hospital trials

Trials by the same sponsor.

NCT06542016 — An Evaluation of the KCCQ Score in Predicting Cardiovascular Risk in Dialysis Patients · recruiting
NCT05540808 — The Value of Full-targeted Pathogen Capture Metagenomics Next Generation Sequencing in Etiological Diagnosis of Sepsis · unknown
NCT05603975 — Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study · NA · unknown
NCT05465980 — Development and Validation of the Prediction Model for Cognitive Impairment · unknown
NCT05452759 — Research of Spiral Exhalation Device Oxygen Therapy to Improve the Treatment Effect of Patients With Severe Pneumonia · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04020328 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shenzhen Second People's Hospital
Last refreshed: 18 February 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04020328.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing