2-HPβCD for Diabetic Kidney Disease

Overseen By Pablo Guzman, M.D

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ZyVersa Therapeutics, Inc.

Must be taking: ACEi, ARB, SGLT2, GLP-1

Must not be taking: Steroids, Cyclodextrin, Antibodies, NSAIDs

Disqualifiers: Solitary kidney, Uncontrolled diabetes, Uncontrolled hypertension, HIV, Hepatitis, 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: 1

Duration: 12 weeks

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is an open label, two to three center study to evaluate the clinical efficacy and safety of 1 dose level of 2-hydroxypropyl-β-cyclodextrin (2-HPβCD) given intravenously in adult patients with type 2 diabetes with diabetic kidney disease (DKD) and proteinuria.

Who Is on the Research Team?

Pablo Pergola, M.D PHD

Principal Investigator

Clinical Advancement Center, PLLC

Are You a Good Fit for This Trial?

Adults with type 2 diabetes and diabetic kidney disease (DKD) who have protein in their urine can join this study. They must be able to consent, have a BMI of ≤40 kg/m^2, stable doses of certain blood pressure meds for 3 months, and agree to use contraception if needed. Those with eGFR between 30-90 mL/min/1.73 m^2 are eligible.

Inclusion Criteria

My BMI is 40 or less.

My kidney test shows protein levels between 400 and 3500 mg/g.

My average urine protein to creatinine ratio is between 400 and 3500 mg/g.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive 2-hydroxypropyl-β-cyclodextrin (2-HPβCD) intravenously to evaluate clinical efficacy and safety

12 weeks

Visits on Day 1, Day 29, Day 57, and Day 85

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 2-HPβCD

Trial Overview The trial is testing the safety and effectiveness of a single dose of an intravenous drug called 2-hydroxypropyl-β-cyclodextrin (2-HPβCD) on patients with DKD. It's an open-label study conducted across two or three centers.

How Is the Trial Designed?

Group I: 2HPβCD Experimental Treatment 1 Intervention

Study drug will be administered by IV infusion during the treatment period.

Who Is Running the Clinical Trial?

ZyVersa Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

8+