Niclosamide Role in Diabetic Nephropathy

• Sponsor: Tanta University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04317430
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 26
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathies	Drug: Niclosamide; Drug: Placebo oral tablet	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Possible Role of Niclosamide in Patients With Diabetic Kidney Disease: Randomized Controlled Study
• Actual Study Start Date: Feb 1, 2020
• Actual Primary Completion Date: Apr 1, 2022
• Actual Study Completion Date: Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment group Niclosamide tablets 1 gram once daily	Drug: Niclosamide; Niclosamide tablets 1 gram once daily
Placebo Comparator: Control group Lactose tablets	Drug: Placebo oral tablet; lactose tablets

Outcome Measures

Primary Outcome Measures

1. Percent change in urinary albumin creatinine ratio (UACR) [6 months]

2. Estimated glomerular filtration rate (eGFR) [After 6 months]

Secondary Outcome Measures

1. Change of Urinary matrix metalloproteinase-7 (MMP-7) level [6 months]

2. Change of Urinary podocalyxin level [6 months]

Other Outcome Measures

1. Change of Urinary 8-hydroxy-2' -deoxyguanosine (8-OHdG) level [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Pharmacy, Tanta University	Tanta		Egypt

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Basma Mahrous El-Fatatry, Dr, Tanta University
• ClinicalTrials.gov Identifier: NCT04317430
• Other Study ID Numbers: NIC2020
• First Posted: Mar 23, 2020
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Basma Mahrous El-Fatatry, Dr, Tanta University: Diabetes - Niclosamide - Diabetic kidney disease
• Additional relevant MeSH terms: Kidney Diseases; Diabetic Nephropathies; Niclosamide

Study Results

No Results Posted as of Jun 21, 2022