Canagliflozin for Diabetic Kidney Disease

Recruiting at3 trial locations

Overseen by Petter MPetter Bjornstad, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Canagliflozin is an oral drug which is currently approved for use in patients with type 2 diabetes by the US Food and Drug Administration (FDA). Canagliflozin acts by increasing salt and sugar loss in the urine, and has shown to protect heart, kidney, and blood vessel function in patients with type 2 diabetes. However, it is unknown how canagliflozin protects the kidneys from disease. Therefore, this study plans to learn more about how canagliflozin works to protect against diabetic kidney disease in adults with type 2 diabetes. This study will use state-of-the-art kidney imaging, kidney biopsies and detailed testing of kidney function to determine the mechanisms of protection afforded by canagliflozin.

Research Team

Petter MPetter Bjornstad, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

Adults aged 18-80 with type 2 diabetes for at least 3 years, kidney function within a specific range (GFR >45 and <90), not on SGLT2 inhibitors or able to do a wash-out. Must not have significant liver, heart, lung diseases, bleeding disorders, massive obesity (BMI ≥45), known allergies to trial drugs or iodine, non-diabetic kidney disease, uncontrolled hypertension or be pregnant.

Inclusion Criteria

I have been diagnosed with type 2 diabetes for 3 years or more.

I am between 18 and 80 years old.

Your urine test shows an albumin-to-creatinine ratio of less than 3000 mg/g.

Exclusion Criteria

I have had an amputation of part of my lower limb.

Conditions likely to interfere with informed consent or compliance with the protocol.

I am not pregnant, not planning to become pregnant, and will use birth control during the study.

Treatment Details

Interventions

• Aminohippurate Sodium Inj 20% (Drug)
• canagliflozin (SGLT2 Inhibitor)

Trial Overview The study is examining how canagliflozin protects against diabetic kidney disease in adults with type 2 diabetes using advanced kidney imaging and tests. It involves taking the oral drug canagliflozin and undergoing detailed assessments of how it affects the kidneys.

Participant Groups

Group I: Treatment Experimental Treatment 2 Interventions

Participants who will receive 100 mg of canagliflozin daily for six (6) months in addition to standard of care.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Dr. Alastair Bell

Boston Medical Center

Chief Executive Officer since 2023

MD from University of Oxford, MBA from Harvard Business School

Dr. Ravin Davidoff

Boston Medical Center

Chief Medical Officer since 2008

M.B., B.Ch. from University of Witwatersrand, South Africa

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons