Phase 2 Study of INV-202 in Patients With Diabetic Kidney Disease (NCT05514548) | Clinical Trial Compass
CompletedPhase 2
Phase 2 Study of INV-202 in Patients With Diabetic Kidney Disease
United States265 participantsStarted 2022-10-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.