Niclosamide Role in Diabetic Nephropathy

Study Overview
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Brief Summary
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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

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

Conditions
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Diabetic Nephropathies

Intervention / Treatment
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* Drug: Niclosamide
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>Niclosamide tablets 1 gram once daily | Drug: Niclosamide<br>* Niclosamide tablets 1 gram once daily<br>|
| Placebo Comparator: Control group<br>Lactose tablets | Drug: Placebo oral tablet<br>* lactose tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urinary albumin creatinine ratio (UACR) |  | 6 months | 
| Estimated glomerular filtration rate (eGFR) |  | After 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Urinary matrix metalloproteinase-7 (MMP-7) level |  | 6 months | 
| Change of Urinary podocalyxin level |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes - Niclosamide - Diabetic kidney disease