Diabetic Kidney Disease MedDRA version: 24.0 Level: LLT Classification code 10084917 Term: Diabetic kidney disease System Organ Class: 100000004857
Conditions
Interventions
Product Name: INV-202
Product Code: INV-202
Pharmaceutical Form: Tablet
INN or Proposed INN: Not yet available
CAS Number: 2712480-46-9
Current Sponsor code: INV-202
Concentration unit: mg milligram(s
Sponsors
Inversago Pharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female participants =18 years of age. 2.Able and willing to give informed consent and to comply with scheduled visits and trial procedures. 3.A diagnosis of DKD due to T1DM or T2DM (diagnosed for =1 year). 4.On a stable anti-diabetic medication regimen for =4 months prior to randomization with a HbA1c 100 mg/g and =65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1. 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. 2. Participants not fully vaccinated for COVID-19. 3. Other causes of kidney disease that are not DKD (eg, lupus nephritis). Of note, hypertension is not an exclusion criterion. 4. Participants with an eGFR 160mmHg or diastolic measurements >100mmHg at the Screening Visit. 8. Active substance abuse including inhaled or injection drugs in the year prior to screening. 9. Use of cannabis or cannabinoid containing compounds within 90 days prior to screening. 10. Pregnancy, planned pregnancy, potential for pregnancy or unwillingness to use effective birth control during the trial, as well as breast feeding 11. Evidence of moderate to severe hepatic impairment as defined by Child’s Pugh score B or C. 12. Subjects with a history of significant psychiatric disorder. 13. Score of the PHQ-9 =15 at baseline. 14. Current or active malignancy within the past 5 years, except for cancer in situ, or non-melanoma skin cancer such as basal cell or squamous cell carcinoma that has been completely resected. 15. QTc >500 msec at baseline. 16. Any chronic medications started or changed within the past 3 months or at risk of needing to be changed during the study. 17. Participants with a history of hyperthyroidism or other thyroid diseases. 18. Participants taking a strong inducer or inhibitor of cytochrome P450, 3A4, 2D6 or 2C19 by screening. These medications are prohibited during the entire study duration. 19. Having taken any investigational compound within 30 days, or 5 half-lives of the drug, whichever is longer, before the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of INV-202 on albuminuria, UACR in participants with DKD;Secondary Objective: To evaluate the safety and tolerability of INV-202 To evaluate the PK of INV-202 and its metabolite (desacetyl-INV-202) To evaluate the effects of INV-202 on eGFR;Primary end point(s): Change in UACR from baseline to W16;Timepoint(s) of evaluation of this end point: W16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in urine protein to creatinine ratio (UPCR) from baseline to W16 Change in eGFR using serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula from baseline to W16 Change in eGFR using cystatin C and the CKD-EPI formula from baseline to W16;Timepoint(s) of evaluation of this end point: W16 | — |
Countries
Canada, Georgia, Hungary, Israel, Mexico, Serbia, United States
Contacts
Public ContactClinical Trial Information
Inversago Pharma Inc.
Outcome results
None listed