NCT04536181 is a Phase 3 clinical trial of Prednisolone in Steroid-Sensitive Nephrotic Syndrome, sponsored by Children's Hospital of Fudan University.

Who is sponsoring NCT04536181?

NCT04536181 is sponsored by Children's Hospital of Fudan University.

What drugs are being tested in NCT04536181?

Interventions in NCT04536181: Prednisolone, Placebo.

What condition does NCT04536181 study?

NCT04536181 studies Steroid-Sensitive Nephrotic Syndrome.

Is NCT04536181 still recruiting?

NCT04536181 is currently withdrawn. Last updated 17 December 2020.

Last reviewed 2020-12-17 · How we verify

NCT04536181

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

Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome

Withdrawn Phase 3 Last updated 17 December 2020

What this trial tests

Phase 3 trial testing Prednisolone in Steroid-Sensitive Nephrotic Syndrome. Withdrawn.

Timeline

1 January 2021

Primary endpoint
1 September 2022

1 October 2022

Quick facts

Lead sponsor	Children's Hospital of Fudan University
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Start date	1 January 2021
Primary completion	1 September 2022
Estimated completion	1 October 2022
Sites	4 locations across China

Drugs / interventions tested

Prednisolone — full drug profile →
Placebo

Conditions studied

Steroid-Sensitive Nephrotic Syndrome — all drugs for Steroid-Sensitive Nephrotic Syndrome →

Sponsor

Children's Hospital of Fudan University

Who can join

Adults 1 to 6, any sex, with Steroid-Sensitive Nephrotic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a multicentric, prospective, randomized, double blind, placebo controlled trial compared the efficacy of 6 months vs. 3 months of initial prednisolone therapy in decreasing the incidence of FRNS with steroid-sensitive nephrotic syndrome in children age 1 year up to 6 years. Three months tapering prednisolone or placebo are administrated follow by open-label 3 months standard prednisolone therapy.The cumulative incidence of FRNS and adverse events for one year were evaluated in the 3-month and 6-month groups.

Publications & conference data

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

Optimizing the corticosteroid dose in steroid-sensitive nephrotic syndrome.
Christian MT, Maxted AP. · · 2022 · cited 13× · PMID 33611671 · DOI 10.1007/s00467-021-04985-1
Commentary on "Pediatric Idiopathic Steroid-sensitive Nephrotic Syndrome Diagnosis and Therapy - Short version of the updated German Best Practice Guideline (S2e)".
Ehren R, Benz MR, Brinkkötter PT, Dötsch J, et al · · 2021 · cited 2× · PMID 34091755 · DOI 10.1007/s00467-021-05136-2

Verify or expand the search:

Other trials of Prednisolone

Trials testing the same drug.

NCT07072585 — Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leuk · Phase 2, PHASE3 · not yet recruiting
NCT07210008 — "Randomized Controlled Trial Testing the Efficacy of Corticosteroid Therapy Versus Placebo in Fibrotic Hypersensitivity · Phase 3 · not yet recruiting
NCT06953791 — Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Pat · Phase 2 · recruiting
NCT07052929 — Study of ASP2957 in Male Participants With X-linked Myotubular Myopathy Who Need Ventilators · Phase 1, PHASE2 · recruiting
NCT07252271 — Very Low Dose Prednisolone on Newly Diagnosed Rheumatoid Arthritis · Phase 4 · not yet recruiting

Other recruiting trials for Steroid-Sensitive Nephrotic Syndrome

Currently open trials in the same condition.

NCT05786768 — Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syn · Phase 2, PHASE3 · recruiting
NCT06065852 — National Registry of Rare Kidney Diseases · recruiting

Other Children's Hospital of Fudan University trials

Trials by the same sponsor.

NCT04955821 — Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS · not yet recruiting
NCT05862688 — A Cohort Study on Anti-microbial Stewardship in PICU · not yet recruiting
NCT05595239 — Blood Purification in Septic Children · NA · not yet recruiting
NCT07325903 — Research of Integrated Traditional Chinese and Western Medicine on Precocious Puberty · EARLY_PHASE1 · not yet recruiting
NCT07141615 — Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of P · NA · not yet recruiting

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 NCT04536181 (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 Children's Hospital of Fudan University
Last refreshed: 17 December 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/NCT04536181.

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