Niclosamide Role in Diabetic Nephropathy

Diabetic Nephropathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317430
• Other study ID #: NIC2020
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: October 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• Niclosamide
Niclosamide tablets 1 gram once daily
• Placebo oral tablet
lactose tablets

Locations

Country	Name	City	State
Egypt	Faculty of Pharmacy, Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of Urinary 8-hydroxy-2' -deoxyguanosine (8-OHdG) level		6 months
Primary	Change in urinary albumin creatinine ratio (UACR)		6 months
Primary	Estimated glomerular filtration rate (eGFR)		After 6 months
Secondary	Change of Urinary matrix metalloproteinase-7 (MMP-7) level		6 months
Secondary	Change of Urinary podocalyxin level		6 months