Niclosamide Role in Diabetic Nephropathy
Possible Role of Niclosamide in Patients With Diabetic Kidney Disease: Randomized Controlled Study
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 18, 2020
CompletedFirst Posted
Study publicly available on registry
March 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedOctober 20, 2022
October 1, 2022
2.2 years
March 18, 2020
October 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in urinary albumin creatinine ratio (UACR)
6 months
Estimated glomerular filtration rate (eGFR)
After 6 months
Secondary Outcomes (2)
Change of Urinary matrix metalloproteinase-7 (MMP-7) level
6 months
Change of Urinary podocalyxin level
6 months
Other Outcomes (1)
Change of Urinary 8-hydroxy-2' -deoxyguanosine (8-OHdG) level
6 months
Study Arms (2)
Treatment group
ACTIVE COMPARATORNiclosamide tablets 1 gram once daily
Control group
PLACEBO COMPARATORLactose tablets
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Faculty of Pharmacy, Tanta University
Tanta, Egypt
Related Publications (1)
El-Fatatry BM, El-Haggar SM, Ibrahim OM, Shalaby KH. Niclosamide from an anthelmintic drug to a promising adjuvant therapy for diabetic kidney disease: randomized clinical trial. Diabetol Metab Syndr. 2023 Feb 16;15(1):22. doi: 10.1186/s13098-023-00995-1.
PMID: 36793092DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
March 18, 2020
First Posted
March 23, 2020
Study Start
February 1, 2020
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
October 20, 2022
Record last verified: 2022-10