Kidney Disease in Type 2 Diabetics

  • STATUS
    Recruiting
  • sponsor
    AstraZeneca
Updated on 25 March 2021

Summary

Kidney Disease in Type 2 Diabetics

Description

Diabetics are at a higher risk for chronic kidney disease since high blood sugar levels caused by diabetes damage blood vessels in the kidneys. If the blood sugar level remains high over many years, this damage gradually reduces the function of the kidneys. Your kidneys filter wastes and excess fluids from your blood, which are then excreted in your urine. If you have hyperuricemia (excess of uric acid in the blood) and albuminuria (protein in the urine) this may be an indicator of chronic kidney disease.

Northern California Research is conducting a study for participants who have been diagnosed with Type 2 diabetes and hyperuricemia (excess of uric acid in the blood) and albuminuria (protein in the urine). The purpose of this study is to assess if lowering uric acid in the blood with a study medication and Febuxostat, FDA approved medication, improves kidney and/or heart function compared with a placebo.

This is a double-blind study, which means neither you nor the study doctor will know what medication group you will be placed into. You will be randomly assigned by chance (like the flip of a coin) to receive either a combination of the study medication and Febuxostat 80mg or a matching placebo. There’s a 50% chance you could receive study medication or a placebo. You will take the study medication once a day in the morning with water. The study length is 7 months (28 weeks) and includes 8 office visits. All trial-related visits, tests, and medications will be provided to you at no cost. In addition, reimbursement for trial-related time and travel may be provided.

If you suspect you may have chronic kidney disease due to elevated blood sugar levels over the past years give us a call to schedule a screening visit.

Details
Clinical Study IdentifierTX152657
SponsorAstraZeneca
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and Females 18 years or older
Diagnosis with type 2 diabetes
Taking medication for treatment of diabetes type 2

Exclusion Criteria

Body mass index (BMI) >40
Previous history or current diagnosis of HIV, AIDS, Hep B, Hep C
unsuitable or unable to undergo MRI
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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.

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

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