Niclosamide Role in Diabetic Nephropathy

Tanta University

Status and phase: Completed; Phase 3

Conditions: Diabetic Nephropathies

Treatments: Drug: Niclosamide; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04317430

NIC2020

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Treatment group

Active Comparator group

Description:

Niclosamide tablets 1 gram once daily

Treatment:

Drug: Niclosamide

Control group

Placebo Comparator group

Description:

Lactose tablets

Treatment:

Drug: Placebo oral tablet