Niclosamide Role in Diabetic Nephropathy

Possible Role of Niclosamide in Patients With Diabetic Kidney Disease: Randomized Controlled Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04317430

Enrollment

Registered

2020-03-23

Start date

2020-02-01

Completion date

2022-04-01

Last updated

2022-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathies

Keywords

Diabetes - Niclosamide - Diabetic kidney disease

Brief summary

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

Interventions

DRUGNiclosamide

Niclosamide tablets 1 gram once daily

DRUGPlacebo oral tablet

lactose tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients with Type 2 diabetes mellitus at least 5 years ago * Stage 2 and 3 diabetic nephropathy (persistent micro- or macroalbuminuria with urinary albumin creatinine ratio (UACR) \>30mg/g) despite treatment with maximum tolerated dose of ACE inhibitors for at least 8 weeks prior to the screening * Hemoglobin A1c \> 6.5 % with regular use of insulin and/or oral glucose lowering agents

Exclusion criteria

* Type 1 diabetes mellitus * Severe renal impairment (eGFR\< 30 mL/min/1.73 m2 at screening) * Pregnant or lactating women * Chronic heart failure * Inflammatory or autoimmune disease * History of kidney disease other than diabetic nephropathy

Design outcomes

Primary

Measure	Time frame
Change in urinary albumin creatinine ratio (UACR)	6 months
Estimated glomerular filtration rate (eGFR)	After 6 months

Secondary

Measure	Time frame
Change of Urinary matrix metalloproteinase-7 (MMP-7) level	6 months
Change of Urinary podocalyxin level	6 months

Other

Measure	Time frame
Change of Urinary 8-hydroxy-2' -deoxyguanosine (8-OHdG) level	6 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026