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OpenTrials
Completed

NCT Number: NCT04317430

Niclosamide Role in Diabetic Nephropathy

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

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Key information

Conditions

Diabetic Nephropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Pharmacy, Tanta University

Tanta, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Niclosamide

Drug

Niclosamide tablets 1 gram once daily

Placebo oral tablet

Drug

lactose tablets

Primary outcomes

  1. Change in urinary albumin creatinine ratio (UACR)

    Time frame: 6 months

  2. Estimated glomerular filtration rate (eGFR)

    Time frame: After 6 months

Secondary outcomes

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

    Time frame: 6 months

  2. Change of Urinary podocalyxin level

    Time frame: 6 months

Other outcomes

  1. Change of Urinary 8-hydroxy-2' -deoxyguanosine (8-OHdG) level

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 23, 2020
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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