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 States, Canada, Georgia265 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 range
18 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.