Niclosamide Role in Diabetic Nephropathy

Phase 3

Completed

• Conditions: Diabetic Nephropathies
• Interventions: Drug: Placebo oral tablet; Drug: Niclosamide

• Registration Number: NCT04317430
• Lead Sponsor: Tanta University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-23
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo oral tablet	Lactose tablets
Treatment group	Niclosamide	Niclosamide tablets 1 gram once daily

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change of Urinary matrix metalloproteinase-7 (MMP-7) level	6 months
Change of Urinary podocalyxin level	6 months

Trial Locations

Locations (1)

Faculty of Pharmacy, Tanta University; 🇪🇬 Tanta, Egypt