Niclosamide Role in Diabetic Nephropathy

  • STATUS
    Recruiting
  • days left to enroll
    75
  • participants needed
    60
  • sponsor
    Tanta University
Updated on 15 October 2021
diabetes
insulin
type 2 diabetes mellitus
ace inhibitor
glomerular filtration rate
nephropathy
hemoglobin a1c
glycosylated hemoglobin
albumin/creatinine ratio
diabetic nephropathy
microalbumin/creatinine ratio

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

Details
Condition Diabetic Nephropathy, Nephropathy, Kidney Disease (Pediatric), Kidney Disease, Diabetic Kidney Disease
Treatment Placebo Oral Tablet, Niclosamide
Clinical Study IdentifierNCT04317430
SponsorTanta University
Last Modified on15 October 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note