Back to resultsNiclosamide Role in Diabetic Nephropathy
Primary Purpose
Diabetic Nephropathies
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Niclosamide
Placebo oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathies focused on measuring Diabetes - Niclosamide - Diabetic kidney disease
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
Sites / Locations
- Faculty of Pharmacy, Tanta University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment group
Control group
Arm Description
Niclosamide tablets 1 gram once daily
Lactose tablets
Outcomes
Primary Outcome Measures
Change in urinary albumin creatinine ratio (UACR)
Estimated glomerular filtration rate (eGFR)
Secondary Outcome Measures
Change of Urinary matrix metalloproteinase-7 (MMP-7) level
Change of Urinary podocalyxin level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04317430
Brief Title
Niclosamide Role in Diabetic Nephropathy
Official Title
Possible Role of Niclosamide in Patients With Diabetic Kidney Disease: Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies
Keywords
Diabetes - Niclosamide - Diabetic kidney disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
Niclosamide tablets 1 gram once daily
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Lactose tablets
Intervention Type
Drug
Intervention Name(s)
Niclosamide
Intervention Description
Niclosamide tablets 1 gram once daily
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
lactose tablets
Primary Outcome Measure Information:
Title
Change in urinary albumin creatinine ratio (UACR)
Time Frame
6 months
Title
Estimated glomerular filtration rate (eGFR)
Time Frame
After 6 months
Secondary Outcome Measure Information:
Title
Change of Urinary matrix metalloproteinase-7 (MMP-7) level
Time Frame
6 months
Title
Change of Urinary podocalyxin level
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Change of Urinary 8-hydroxy-2' -deoxyguanosine (8-OHdG) level
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Faculty of Pharmacy, Tanta University
City
Tanta
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Niclosamide Role in Diabetic Nephropathy
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