A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Pharmacokinetics of Two Doses of INV-202 in Patients With Diabetic Kidney Disease
Overview
- Phase
- Phase 2
- Intervention
- INV-202
- Conditions
- Diabetic Kidney Disease
- Sponsor
- Inversago Pharma Inc.
- Enrollment
- 265
- Locations
- 70
- Primary Endpoint
- Change in UACR from baseline to W16
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
The study is designed to assess the efficacy, safety, tolerability, and transformation within the human body of INV-202 investigational drug in the treatment of adult participants with a diagnosis of Diabetic Kidney Disease due to either Type 1 diabetes mellitus or Type 2 diabetes mellitus.
Detailed Description
This is a Phase 2, randomized, double-blind, placebo controlled, dose ranging, multicenter study designed to assess the efficacy, safety, tolerability, and pharmacokinetics of INV-202 for the treatment of adult participants with a diagnosis of DKD due to either Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) (diagnosed ≥1 year) who are on a stable anti diabetic medication regimen for ≥4 months prior with a HbA1c \<9.5%. Approximately 240 participants (80/arm) will be randomized to 1 of 3 treatment arms in a 1:1:1 ratio: INV 202 10 mg, INV-202 25 mg, or placebo. The assigned study treatment will be taken once daily (QD), for 16 weeks. Due to the high expected screen failure rates, participants may be pre-screened at sites with an approved pre-screening ICF. Each participant will be allowed 1 retest during the screening period if they fail screening and 1 re-screening on a case by case basis with approval from the Worldwide medical monitors. Study participation will last approximately 22 weeks and includes a Screening Period (up to 4 weeks), a Study Treatment Period with 16 weeks of daily study treatment, and a Safety Follow-Up Visit consisting of a phone call 2 weeks after the End of Treatment Visit (Week \[W\]18) to allow reporting of any adverse events following withdrawal of the study drug. Any participant who withdraws before completing treatment will be requested to return for an Early Termination Visit, at which time the procedures normally scheduled for the W16 visit will be conducted.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female participants ≥18 years of age.
- •Able and willing to give informed consent and to comply with scheduled visits and trial procedures.
- •A diagnosis of DKD due to either T1DM or T2DM (diagnosed for ≥1 year)
- •On a stable anti-diabetic medication regimen for ≥4 months prior to randomization with a hemoglobin A1C (HbA1c) \<9.5%.
- •Participants with T1DM may not be on any glucose lowering medications beyond insulin.
- •Participants with T2DM may be on more than 1 anti diabetic medication regimen (eg, SGLT2 inhibitor, insulin, or other anti-diabetic medication regimen).
- •HbA1c should have been performed within the last 4 months prior to randomization.
- •Participants must be on a stable dose of ACEi or ARB for ≥4 months prior to randomization and expected to remain stable for the 4-month treatment period.
- •Participants taking finerenone (not required), on a stable dose for ≥4 months prior to randomization.
- •Presence of albuminuria with a UACR \>100 mg/g and \<3000 mg/g at screening.
Exclusion Criteria
- •Significant medical condition, that in the opinion of the Investigator will place the participant at risk during the study or that will confound the study endpoints.
- •Participants not fully vaccinated for Coronavirus Disease 2019 (COVID 19).
- •Participants will be considered fully vaccinated if they have received all recommended doses of a COVID-19 vaccine that has been authorized or approved by the United States Food and Drug Administration (FDA) or is listed for emergency use by the World Health Organization within 14 days prior to the first dose of the study drug.
- •Participants who have fully recovered from COVID 19 and have a negative COVID-19 test ≥14 days before screening are eligible.
- •Other causes of kidney disease that are not DKD (eg, lupus nephritis). Of note, hypertension is not an exclusion criteria.
- •Participants with an eGFR \<30 ml/min/1.73m².
- •Participants who have had acute kidney injury (AKI) within the past 3 months, or have ever received dialysis.
- •Participants with a history of epilepsy or intracranial surgery.
- •Uncontrolled hypertension with measurements of systolic pressures \>160 or diastolic measurements \>100 at the Screening Visit.
- •Active substance abuse including inhaled or injection drugs in the year prior to screening.
Arms & Interventions
INV 202 10 mg
INV-202 10 mg Arm
Intervention: INV-202
INV-202 25 mg
INV-202 25 mg Arm
Intervention: INV-202
Placebo
Placebo Arm
Intervention: Placebo
Outcomes
Primary Outcomes
Change in UACR from baseline to W16
Time Frame: 16 weeks
Measure of UACR at W16 in comparison to baseline to evaluate the effect of INV-202 in participants with diabetic kidney disease (DKD)
Secondary Outcomes
- Change in urine protein to creatinine ratio (UPCR) from baseline to W16(16 weeks)
- Change in eGFR using cystatin C and the CKD-EPI formula from baseline to W16(16 weeks)
- Change in eGFR using serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula from baseline to W16(16 weeks)