Diabetic NephropathiesPhase 3NCT04317430
Niclosamide Role in Diabetic Nephropathy
A Phase 3 study testing Niclosamide in people with Diabetic Nephropathies, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- Niclosamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 1 Apr 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Possible Role of Niclosamide in Patients With Diabetic Kidney Disease: Randomized Controlled Study
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
- Conditions
- Diabetic Nephropathies
- Being tested
- Niclosamide, Placebo oral tablet
- Keywords
- Diabetes - Niclosamide - Diabetic kidney disease
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiclosamideDrug
Niclosamide tablets 1 gram once daily
Placebo oral tabletDrug
lactose tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | Niclosamide tablets 1 gram once daily Receives: Drug: Niclosamide |
| Control group | Placebo comparator | Lactose tablets Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary albumin creatinine ratio (UACR)
Measured: 6 months
Estimated glomerular filtration rate (eGFR)
Measured: After 6 months
Secondary outcomes (2)
Change of Urinary matrix metalloproteinase-7 (MMP-7) level
Measured: 6 months
Change of Urinary podocalyxin level
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start1 Feb 2020
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Mahrous El-Fatatry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317430
- Sponsor's protocol ID
- NIC2020
- Status last verified
- Oct 2022
- First submitted
- 18 Mar 2020
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36793092
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Role of Niclosamide in Patients With Diabetic Kidney Disease: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04317430
- Acronym / sponsor ID
- NIC2020
- Conditions
- Diabetic Nephropathies
- Keywords
- Diabetes - Niclosamide - Diabetic kidney disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Drug: NiclosamideNiclosamide tablets 1 gram once daily |
| Control group | Placebo comparator | Drug: Placebo oral tabletLactose tablets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiclosamideNiclosamide tablets 1 gram once daily | Drug | Treatment group |
| Placebo oral tabletlactose tablets | Drug | Control group |
Primary outcome
Change in urinary albumin creatinine ratio (UACR)
Time frame: 6 months
Estimated glomerular filtration rate (eGFR)
Time frame: After 6 months
2 secondary outcomes
Change of Urinary matrix metalloproteinase-7 (MMP-7) level
Time frame: 6 months
Change of Urinary podocalyxin level
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Derived from this study: PubMed 36793092El-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Niclosamide in people with Diabetic Nephropathies, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urinary albumin creatinine ratio (UACR) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04317430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.