Canagliflozin for Diabetic Kidney Disease

Recruiting at 3 trial locations

Overseen By Jessica Kendrick, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Must be taking: RAAS inhibitors, GLP-1 agonists

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Liver disorders, Cardiovascular disease, Pulmonary diseases, Renal-urinary disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the drug canagliflozin protects kidneys in people with type 2 diabetes. Canagliflozin already helps these patients by increasing the loss of salt and sugar through urine, but its kidney-protective effects remain unclear. The trial will use advanced imaging and testing to explore these effects further. People with type 2 diabetes for at least 3 years who are on certain treatments might be a good fit. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on a RAAS inhibitor or a GLP-1 receptor agonist, you must have been taking them for at least 3 months before the study. If you are on steroids, immunosuppressants, or investigational drugs not related to this trial, you cannot participate.

Is there any evidence suggesting that canagliflozin is likely to be safe for humans?

Research has shown that canagliflozin is generally well-tolerated by people with type 2 diabetes. Studies have found that it not only helps lower blood sugar but also protects the kidneys and heart. For example, one study found that people taking canagliflozin had a lower risk of kidney failure compared to those taking a placebo, resulting in fewer serious kidney problems.

Another study demonstrated that canagliflozin safely prevented major kidney and heart issues in people with diabetes. Canagliflozin is already approved by the FDA for managing type 2 diabetes, indicating its safety for this condition.

While side effects can occur, evidence suggests that canagliflozin is safe for adults with type 2 diabetes. This trial aims to learn more about its role in kidney protection. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for diabetic kidney disease, which often include blood pressure medications, glucose control, and lifestyle changes, canagliflozin offers a unique approach. Canagliflozin works by inhibiting the sodium-glucose co-transporter 2 (SGLT2), which helps the kidneys remove excess glucose through urine. This not only helps control blood sugar levels but also has shown potential benefits in protecting kidney function. Researchers are excited about canagliflozin because it targets the disease differently and may provide additional renal protection beyond traditional therapies.

What is the effectiveness track record for canagliflozin in protecting against diabetic kidney disease?

Research shows that canagliflozin improves kidney health in people with type 2 diabetes. In studies, participants taking canagliflozin had a lower risk of kidney failure compared to those on a placebo. The CREDENCE trial found that canagliflozin slowed the progression of diabetic kidney disease and reduced the risk of serious kidney issues, such as needing dialysis or a kidney transplant. Overall, canagliflozin protects the kidneys by helping the body eliminate excess salt and sugar through urine. ^{1 3 6 7 8}

Who Is on the Research Team?

Petter Bjornstad, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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.

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 100 mg of canagliflozin daily for six months in addition to standard of care

6 months

Regular visits for imaging and biopsies

Follow-up

Participants are monitored for safety and effectiveness after treatment

Annually until death or end-stage kidney disease

Annual visits

Open-label extension (optional)

Participants may opt into continuation of SGLT2 inhibitor treatment free of charge until Jan 2028

Until Jan 2028

Annual remote visits

What Are the Treatments Tested in This Trial?

Interventions

• Aminohippurate Sodium Inj 20%
• canagliflozin

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.

How Is the Trial Designed?

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+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa1811744

Canagliflozin and Renal Outcomes in Type 2 Diabetes and ... The risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7261301/

Canagliflozin for the Treatment of Diabetic Kidney Disease ... Overall, the CREDENCE trial demonstrated that canagliflozin improves renal outcomes and slows early disease progression in people with DKD.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02065791

NCT02065791 | Evaluation of the Effects of Canagliflozin ... The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30990260/

Canagliflozin and Renal Outcomes in Type 2 Diabetes and ... The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 ...

5. invokanahcp.com invokanahcp.com/dkd-benefit/

DKD Benefit | INVOKANA® (canagliflozin) HCP INVOKANA® reduced the relative risk of the primary composite outcome of end-stage kidney disease, doubling of serum creatinine, and renal or CV death.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7217416/

Renal, Cardiovascular, and Safety Outcomes of Canagliflozin ... Canagliflozin safely prevents clinically important renal and cardiovascular events in people with diabetes, substantial albuminuria, and an eGFR at commencement ...

7. invokanahcp.com invokanahcp.com/safety-profiles/

Safety Profile | INVOKANA® (canagliflozin) HCP INVOKANA® 100 mg has a proven safety profile in adult patients with DKD and T2D who have an eGFR as low as 30.

8. diabetesjournals.org diabetesjournals.org/care/article/47/3/501/154163/Impact-of-Canagliflozin-on-Kidney-and

Impact of Canagliflozin on Kidney and Cardiovascular ... Canagliflozin demonstrated CV and kidney benefits, including a reduction in CKD progression regardless of diabetes duration. These findings may ...