Niclosamide Role in Diabetic Nephropathy | NCT04317430

Studies
Niclosamide Role in Diabetic Nephropathy

NCT04317430

Sponsor

Tanta University

Status

Completed

Last Update Posted

Oct 20, 2022Actual

Enrollment

60Actual

Phase

Phase 3

Conditions

Diabetic Nephropathies

Interventions

Niclosamide
Placebo oral tablet

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2020Actual

Primary Completion Date

Apr 1, 2022Actual

Completion Date

Apr 1, 2022Actual

First Submitted Date

Mar 18, 2020

First Submission Date that Met QC Criteria

Mar 19, 2020

First Posted Date

Mar 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2022

Last Update Posted Date

Oct 20, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Active Comparator	Niclosamide tablets 1 gram once daily	Drug: Niclosamide
Control group	Placebo Comparator	Lactose tablets	Drug: Placebo oral tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Niclosamide	Drug	Niclosamide tablets 1 gram once daily	Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in urinary albumin creatinine ratio (UACR)		6 months
Estimated glomerular filtration rate (eGFR)		After 6 months

Secondary Outcomes

Measure	Description	Time Frame
Change of Urinary matrix metalloproteinase-7 (MMP-7) level		6 months
Change of Urinary podocalyxin level		6 months

Other Outcomes

Measure	Description	Time Frame
Change of Urinary 8-hydroxy-2' -deoxyguanosine (8-OHdG) level		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Pharmacy, Tanta University		Tanta			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36793092	Derived	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.

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D012458	Salicylanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals