Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2020-02-01
2022-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
NCT03436693
Nephroprotective Effect of Nicorandil in Type 2 Diabetes Mellitus
NCT06430125
Clinical Outcome of Vinpocetine in Diabetic Nephropathy
NCT06441591
Renoprotective Effects of Dapagliflozin Versus Pentoxiphylline in Chronic Kidney Disease Patients
NCT06421870
Efficacy of Dapagliflozin in Early Diabetic Nephropathy in Type 1 Diabetes
NCT06532682
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment group
Niclosamide tablets 1 gram once daily
Niclosamide
Niclosamide tablets 1 gram once daily
Control group
Lactose tablets
Placebo oral tablet
lactose tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Niclosamide
Niclosamide tablets 1 gram once daily
Placebo oral tablet
lactose tablets
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tanta University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Basma Mahrous El-Fatatry
Dr
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Pharmacy, Tanta University
Tanta, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NIC2020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.