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INV 202 for Diabetic Kidney Disease
Verified Trial
Phase 2
Recruiting
Research Sponsored by Inversago Pharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have you been diagnosed with Diabetic Kidney Disease due to Type 1 Diabetes or Type 2 Diabetes?
Is your hemoglobin A1C (HbA1c) less than 9.5%?
Must not have
Do you have a history of thyroid problems, such as hyperthyroidism?
Do you have a history of severe mental health disorders such as depression, bipolar disorder or schizophrenia?
Timeline
Screening 4 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Study Summary
This trial is testing an investigational drug for adults with Diabetic Kidney Disease due to Type 1 or Type 2 diabetes to see if it’s safe, effective and well-tolerated.
Who is the study for?
This trial is for adults with Diabetic Kidney Disease linked to Type 1 or Type 2 diabetes, who have managed their diabetes stably for at least 4 months and have an HbA1c below 9.5%. It's not for those with recent drug abuse, thyroid issues, significant psychiatric disorders, other kidney diseases (except hypertension), or those using cannabis products recently.Check my eligibility
What is being tested?
The study tests INV-202 against a placebo in treating Diabetic Kidney Disease. Participants will be randomly assigned to receive either the investigational drug INV-202 or a placebo to evaluate its effectiveness and safety.See study design
What are the potential side effects?
While specific side effects of INV-202 are not listed here, common ones may include reactions at the injection site, nausea, fatigue, and potential allergic responses. Safety and tolerability are key aspects being monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Diabetic Kidney Disease.
Select...
I have been on a stable diabetes medication regimen for at least 4 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of thyroid issues, like hyperthyroidism.
Timeline
Screening ~ 4 weeks1 visit
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 4 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in UACR from baseline to W16
Secondary outcome measures
Change in albuminuria from basline to W16
Change in biomarkers (such as weight), markers of glucose, lipids and renal fibrosis
Change in glomerular filtration rate using serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula from baseline to W16
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: INV-202 25 mgExperimental Treatment1 Intervention
INV-202 25 mg Arm
Group II: INV 202 10 mgExperimental Treatment1 Intervention
INV-202 10 mg Arm
Group III: PlaceboPlacebo Group1 Intervention
Placebo Arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INV-202
2022
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
Inversago Pharma Inc.Lead Sponsor
3 Previous Clinical Trials
320 Total Patients Enrolled
Worldwide Clinical TrialsOTHER
61 Previous Clinical Trials
14,147 Total Patients Enrolled
Glenn Crater, MDStudy DirectorInversago Pharma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Diabetic Kidney Disease.You have a history of severe mental health disorders such as depression, bipolar disorder or schizophrenia, or have had thoughts of suicide or attempted suicide in the past two years. If your score is 15 or higher on the PHQ-9 questionnaire, you will also be excluded.I have had epilepsy or brain surgery in the past.You have taken any experimental medication within the past month or within 5 half-lives of the drug, whichever is longer.You have used illegal drugs by inhaling or injecting them within the past year.You have used cannabis or any products containing cannabinoids in the last 90 days before screening.I have been on a stable diabetes medication regimen for at least 4 months.I have a history of thyroid issues, like hyperthyroidism.I have had thyroid problems, including hyperthyroidism.You have a medical condition that might put you at risk during the study, or make it difficult to measure the study's goals.My kidney disease is not caused by conditions like lupus.
Research Study Groups:
This trial has the following groups:- Group 1: INV 202 10 mg
- Group 2: INV-202 25 mg
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 4 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05514548 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the dosage of INV 202 10 mg received regulatory approval?
"INV 202 10 mg's safety has been supported by a few studies, giving it an assessment of 2. However, there is not yet any data demonstrating its efficacy."
Answered by AI
Are there a plethora of medical centers conducting this clinical research within the United States?
"This clinical trial is accepting enrollees from a total of 20 locations, such as the Mountain Kidney & Hypertension Associates in Asheville, the North Texas Endocrine Center in Dallas, and Biopharma Informatic LLC in Houston."
Answered by AI
Is enrollment currently open for this research project?
"The trial is open for recruitment, as indicated on clinicaltrials.gov; it was originally posted in October 19th 2022 and the last edit to its description happened on October 31st of that same year."
Answered by AI
What is the current sampling count for this experiment?
"Affirmative. Clinicaltrials.gov documents that this clinical trial, which was first released on October 19th 2022, is actively recruiting participants. A total of 240 volunteers are needed from 20 various study sites."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Texas
California
Other
How old are they?
18 - 65
65+
What site did they apply to?
Site 102: Research by Design, LLC
Site 124: Endocrine Research Solutions, Inc.
Site 117: Biopharma Informatic, LLC
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+
1
0
Why did patients apply to this trial?
I to be the cure. Please find a cure. My A1C is too high. A cure for diabetes.
PatientReceived 1 prior treatment
Find a cure for CKD.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long does it last? Can this trial help me? What is it that you do? How long do visits take?
PatientReceived no prior treatments
What are the side effects?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Phone Call
Most responsive sites:
- Site 102: Research by Design, LLC: < 24 hours
- Site 104: South Carolina Clinical Research LLC: < 24 hours
- Site 107: National Institute of Clinical Research - Garden Grove: < 24 hours
Average response time
- < 2 Days
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