Possible Role of Niclosamide in Patients With Diabetic Kidney Disease: Randomized Controlled Study
Overview
- Phase
- Phase 3
- Intervention
- Niclosamide
- Conditions
- Diabetic Nephropathies
- Sponsor
- Tanta University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in urinary albumin creatinine ratio (UACR)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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
Investigators
Basma Mahrous El-Fatatry
Dr
Tanta University
Eligibility Criteria
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
Arms & Interventions
Treatment group
Niclosamide tablets 1 gram once daily
Intervention: Niclosamide
Control group
Lactose tablets
Intervention: Placebo oral tablet
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(6 months)
- Change of Urinary podocalyxin level(6 months)