NCT04317430 is a Phase 3 clinical trial of Niclosamide in Diabetic Nephropathies, sponsored by Tanta University.

Who is sponsoring NCT04317430?

NCT04317430 is sponsored by Tanta University.

What drugs are being tested in NCT04317430?

Interventions in NCT04317430: Niclosamide, Placebo oral tablet.

What condition does NCT04317430 study?

NCT04317430 studies Diabetic Nephropathies.

Is NCT04317430 still recruiting?

NCT04317430 is currently completed. Last updated 20 October 2022.

Last reviewed 2022-10-20 · How we verify

NCT04317430

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

Niclosamide Role in Diabetic Nephropathy

Completed Phase 3 Last updated 20 October 2022

What this trial tests

Phase 3 trial testing Niclosamide in Diabetic Nephropathies in 60 participants. Completed in 1 April 2022.

Timeline

1 February 2020

Primary endpoint
1 April 2022

1 April 2022

Quick facts

Lead sponsor	Tanta University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 February 2020
Primary completion	1 April 2022
Estimated completion	1 April 2022
Sites	1 location across Egypt

Drugs / interventions tested

Niclosamide — full drug profile →
Placebo oral tablet — full drug profile →

Conditions studied

Diabetic Nephropathies — all drugs for Diabetic Nephropathies →

Sponsor

Tanta University

Who can join

Adults 18 to 80, any sex, with Diabetic Nephropathies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is randomized, controlled, parallel, prospective clinical study will be conducted on 60 patients diagnosed with type 2 diabetes mellitus at least five years ago. Patients will be recruited from Tanta University Hospital, Tanta, Egypt. Accepted patients will be randomized into 2 groups as the following: Control group: 30 patients will receive maximum tolerated dose of ACEI plus placebo pills for six months Treatment group: 30 patients will receive maximum tolerated dose of ACEI plus niclosamide tablets 1 gram once daily for six months The primary end point will be the change in Urinary albumin to creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) after six months of treatment

Publications & conference data

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

Diabetic kidney disease in type 2 diabetes: a review of pathogenic mechanisms, patient-related factors and therapeutic options.
Woodhams L, Sim TF, Chalmers L, Yeap B, et al · · 2021 · cited 9× · PMID 33976959 · DOI 10.7717/peerj.11070
Niclosamide from an anthelmintic drug to a promising adjuvant therapy for diabetic kidney disease: randomized clinical trial.
El-Fatatry BM, El-Haggar SM, Ibrahim OM, Shalaby KH. · · 2023 · cited 5× · PMID 36793092 · DOI 10.1186/s13098-023-00995-1
Decoding organ fibrosis: mechanistic insights and emerging therapeutic strategies.
Chen X, Zhang J, Guo L, Wu C, et al · · 2026 · cited 2× · PMID 41786685 · DOI 10.1038/s41392-025-02532-0

Verify or expand the search:

Other trials of Niclosamide

Trials testing the same drug.

NCT04932915 — Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19 · Phase 2 · terminated
NCT04858425 — Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection · Phase 2 · terminated
NCT04870333 — PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V · Phase 2, PHASE3 · completed
NCT04705415 — A Single and Multiple Ascending Dose Study of Niclosamide in Healthy Volunteers · Phase 1 · completed
NCT04644705 — Safety and Pharmacokinetics of a Novel Niclosamide Solution in Combination With Camostat · Phase 1 · completed

Other recruiting trials for Diabetic Nephropathies

Currently open trials in the same condition.

NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting
NCT07187713 — ACE Reno, Pico Cell Matrix and Its Effect on eGFR in Chronic Kidney Diseases · Phase 4 · recruiting
NCT06778018 — Nutritional Outcomes of Lotus Seed (Nelumbo Nucifera) on Diabetic Sensorimotor Polyneuropathy · NA · recruiting
NCT06441591 — Clinical Outcome of Vinpocetine in Diabetic Nephropathy · Phase 2, PHASE3 · recruiting
NCT06431477 — Efficacy and Safety of Telmisartan Compared With Losartan · Phase 4 · recruiting

Other Tanta University trials

Trials by the same sponsor.

NCT07398651 — Apremilast and Adalimumab in Psoriatic Arthritis Patients · NA · not yet recruiting
NCT06966856 — This Randomized, Clinical Trial Evaluates the Efficacy of Oral Versus Sublingual Vitamin B12 Supplementation in Correcti · Phase 3 · not yet recruiting
NCT07334197 — Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy · NA · not yet recruiting
NCT07498998 — Glucocorticoid, Ozone and 5% Dextrose Local Injection for Pain Relief in Carpal Tunnel Syndrome · NA · not yet recruiting
NCT07114250 — Comparative Study Between Spinal Anesthesia Versus General Anesthesia in Supine Percutaneous Nephrolithotomy Operation · 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 NCT04317430 (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 Tanta University
Last refreshed: 20 October 2022

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/NCT04317430.

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