Niclosamide Role in Diabetic Nephropathy

Tanta University60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Nephropathies

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in urinary albumin creatinine ratio (UACR)

Time frame: 6 months

Estimated glomerular filtration rate (eGFR)

Time frame: After 6 months

Secondary Outcomes

Change of Urinary matrix metalloproteinase-7 (MMP-7) level

Time frame: 6 months

Change of Urinary podocalyxin level

Time frame: 6 months

Niclosamide Role in Diabetic Nephropathy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes