INV 202 for Diabetic Kidney Disease

Recruiting at 72 trial locations

Overseen By Sara Bartolanzo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Inversago Pharma Inc.

Must be taking: ACEi, ARB

Must not be taking: Cannabis, Cytochrome P450 drugs

Disqualifiers: Uncontrolled hypertension, Hepatic impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

265 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called INV-202 in adults with Diabetic Kidney Disease caused by Type 1 or Type 2 diabetes. The goal is to see if the drug is effective, safe, and well-tolerated, and how it behaves in the body.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of your current anti-diabetic medications and ACEi or ARB for at least 4 months before and during the study. However, you cannot take certain medications that affect liver enzymes (cytochrome P450) during the study.

What data supports the effectiveness of the drug INV-202 for treating diabetic kidney disease?

The research suggests that targeting inflammation and fibrosis, as seen in the FIDELIO-DKD trial with a similar drug, can be effective in treating diabetic kidney disease. This indicates that INV-202 might also be beneficial if it works in a similar way. ^{1 2 3 4 5}

Is INV-202 safe for humans?

The safety of INV-202, which may be similar to other sodium-glucose co-transporter 2 inhibitors (SGLT2i), shows a generally favorable safety profile. While there are some risks like diabetic ketoacidosis (a serious diabetes complication) and genital infections, these are outweighed by the benefits such as reduced risk of heart and kidney issues. ^{6 7 8 9 10}

Research Team

Glenn Crater, MD

Principal Investigator

Inversago Pharma

Eligibility Criteria

This trial is for adults with Diabetic Kidney Disease linked to Type 1 or Type 2 diabetes, who have managed their diabetes stably for at least 4 months and have an HbA1c below 9.5%. It's not for those with recent drug abuse, thyroid issues, significant psychiatric disorders, other kidney diseases (except hypertension), or those using cannabis products recently.

Inclusion Criteria

I have been diagnosed with Diabetic Kidney Disease.

Is your hemoglobin A1C (HbA1c) less than 9.5%?

I have been on a stable diabetes medication regimen for at least 4 months.

Exclusion Criteria

You have a history of severe mental health disorders such as depression, bipolar disorder or schizophrenia, or have had thoughts of suicide or attempted suicide in the past two years. If your score is 15 or higher on the PHQ-9 questionnaire, you will also be excluded.

I have had epilepsy or brain surgery in the past.

You have taken any experimental medication within the past month or within 5 half-lives of the drug, whichever is longer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive the study medication (INV-202 10 mg, INV-202 25 mg, or placebo) once daily for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a Safety Follow-Up Visit via phone call 2 weeks after the End of Treatment Visit

2 weeks

Treatment Details

Interventions

• INV-202
• Placebo

Trial Overview The study tests INV-202 against a placebo in treating Diabetic Kidney Disease. Participants will be randomly assigned to receive either the investigational drug INV-202 or a placebo to evaluate its effectiveness and safety.

Participant Groups

Group I: INV-202 25 mg Experimental Treatment 1 Intervention

INV-202 25 mg Arm

Group II: INV 202 10 mg Experimental Treatment 1 Intervention

INV-202 10 mg Arm

Group III: Placebo Placebo Group 1 Intervention

Placebo Arm

Who Is Running the Clinical Trial?

Inversago Pharma Inc.

Lead Sponsor

Trials

4

Recruited

590+

Worldwide Clinical Trials

Collaborator

Trials

70

Recruited

15,800+

Findings from Research

Sotagliflozin, a new medication for diabetes, was found to be safe for renal function, showing no significant adverse effects on kidney health in a review of 14 studies involving 17,574 participants, including those with existing renal impairment.

The drug did not significantly change urinary albumin excretion or the risk of composite renal events, indicating that while it is safe, more research is needed to fully understand its effectiveness in preventing diabetic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the dual sodium-glucose co-transporter-1 and -2 inhibitor sotagliflozin on renal outcomes in type 1 diabetes and type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials. Bantounou, MA., Sardellis, P., Thuemmler, R., et al.[2023]

Dapagliflozin, used to treat type 2 diabetes, showed only small and temporary reductions in kidney function (eGFR) at week 1, which returned to baseline by week 24 and remained stable up to 102 weeks, indicating its renal safety.

The frequency of renal adverse events with dapagliflozin was similar to that of placebo, with very few serious events reported, suggesting that dapagliflozin does not increase the risk of acute renal toxicity in patients with normal or mildly impaired kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dapagliflozin on renal function in patients with type 2 diabetes. Kohan, DE., Fioretto, P., Johnsson, K., et al.[2021]

References

1. France pubmed.ncbi.nlm.nih.gov

Prognosis and treatment of diabetic nephropathy: Recent advances and perspectives. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

[Diabetic microangiopathy]. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Finerenone: A Non-steroidal Mineralocorticoid Receptor Blocker for Diabetic Kidney Disease. [2022]

4. Belgium pubmed.ncbi.nlm.nih.gov

[Renal complications of diabetes]. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Concomitance of diabetic retinopathy and proteinuria accelerates the rate of decline of kidney function in type 2 diabetic patients. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial: baseline characteristics. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The cardiovascular outcomes, heart failure and kidney disease trials tell that the time to use Sodium Glucose Cotransporter 2 inhibitors is now. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Effect of the dual sodium-glucose co-transporter-1 and -2 inhibitor sotagliflozin on renal outcomes in type 1 diabetes and type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials. [2023]

9. Italy pubmed.ncbi.nlm.nih.gov

The effect of dapagliflozin on renal function in patients with type 2 diabetes. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Hypoglycemia Risk With SGLT2 Inhibitors or Glucagon-Like Peptide 1 Receptor Agonists Versus Sulfonylureas Among Medicare Insured Adults With CKD in the United States. [2022]