Niclosamide Role in Diabetic Nephropathy

  • days left to enroll
  • participants needed
  • sponsor
    Tanta University
Updated on 15 October 2021
type 2 diabetes mellitus
ace inhibitor
glomerular filtration rate
hemoglobin a1c
glycosylated hemoglobin
albumin/creatinine ratio
diabetic nephropathy
microalbumin/creatinine ratio


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 Diabetic Nephropathy, Nephropathy, Kidney Disease (Pediatric), Kidney Disease, Diabetic Kidney Disease
Treatment Placebo Oral Tablet, Niclosamide
Clinical Study IdentifierNCT04317430
SponsorTanta University
Last Modified on15 October 2021


Yes No Not Sure

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
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