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Canagliflozin for Diabetic Kidney Disease
Study Summary
This trial is studying how well canagliflozin works to protect the kidneys in adults with type 2 diabetes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have had an amputation of part of my lower limb.I have been diagnosed with type 2 diabetes for 3 years or more.I am not pregnant, not planning to become pregnant, and will use birth control during the study.I am between 18 and 80 years old.I do not have significant liver, heart, lung, kidney, or blood disorders.Your urine test shows an albumin-to-creatinine ratio of less than 3000 mg/g.I have been on a GLP-1 receptor agonist medication for at least 3 months.My kidney disease is not caused by diabetes.I do not have chronic conditions like lupus or cancer that could affect my kidney function or survival.I have taken SGLT2 inhibitors and cannot stop them for a trial.I am allergic to canagliflozin or iodine.You are allergic to iodine used in contrast material or shellfish.Your kidney function, as measured by a blood test, should be neither too low nor too high.My BMI is 45 or higher, making certain medical procedures more challenging.I cannot safely stop my blood thinners for a kidney biopsy.I am not on steroids, immunosuppressants, or new drugs not part of this trial.I have been taking the highest dose I can tolerate of a RAAS inhibitor for at least 3 months.I have had a fracture due to osteoporosis.My blood pressure is very high or uncontrolled.I have blood in my urine and the cause has been checked and documented.
- Group 1: Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What primary goal does this experiment hope to accomplish?
"The primary objective of this six-month study is to observe changes in Glomerular basement membrane (GBM) width and mesangial expansion. Medullary R2, Renal Perfusion, and Glomerular Filtration Rate (GFR) will also be monitored as secondary outcomes."
How many people fit the bill for participating in this trial?
"Yes, the trial is ongoing and patients are being enrolled at 4 locations. The clinicaltrials.gov website shows that the trial was first posted on October 10th, 2020, and was last updated on October 31st, 2020. The goal is to enroll 40 patients in total."
What have been the most serious reported side effects of canagliflozin?
"While there is some evidence to support canagliflozin's safety, it is only from early phase clinical trials. More research is needed to support its efficacy."
Does the age limit for this clinical trial extend to those who are younger than 25 years old?
"This particular clinical trial is only open to adults aged 18-80. However, there are 66 other trials for minors and 770 trials for seniors."
Are we currently recruiting volunteers for this research project?
"The most recent update on clinicaltrials.gov was on 10/31/2022, which confirms that the study is still recruiting patients. This particular trial was posted on 10/10/2022 and is looking for 40 individuals total from 4 different locations."
Who else is applying?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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