Diabetic Kidney Disease Clinical Trial
Official title:
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
Verified date | May 2024 |
Source | Inversago Pharma Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 265 |
Est. completion date | September 24, 2024 |
Est. primary completion date | July 3, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 either T1DM or T2DM (diagnosed for =1 year) 4. On a stable anti-diabetic medication regimen for =4 months prior to randomization with a hemoglobin A1C (HbA1c) <9.5%. 1. Participants with T1DM may not be on any glucose lowering medications beyond insulin. 2. Participants with T2DM may be on more than 1 anti diabetic medication regimen (eg, SGLT2 inhibitor, insulin, or other anti-diabetic medication regimen). 3. HbA1c should have been performed within the last 4 months prior to randomization. 5. 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. 6. Participants taking finerenone (not required), on a stable dose for =4 months prior to randomization. 7. Presence of albuminuria with a UACR >100 mg/g and <3000 mg/g at screening. 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 Coronavirus Disease 2019 (COVID 19). 1. 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. 2. Participants who have fully recovered from COVID 19 and have a negative COVID-19 test =14 days before screening are eligible. 3. Other causes of kidney disease that are not DKD (eg, lupus nephritis). Of note, hypertension is not an exclusion criteria. 4. Participants with an eGFR <30 ml/min/1.73m². 5. Participants who have had acute kidney injury (AKI) within the past 3 months, or have ever received dialysis. 6. Participants with a history of epilepsy or intracranial surgery. 7. Uncontrolled hypertension with measurements of systolic pressures >160 or diastolic measurements >100 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 B or C. 12. Subjects with a history of significant psychiatric disorder, including but not limited to: 1. Major depression within the last 2 years. 2. Any history of a suicide attempt or suicidal ideation. 3. Subjects with a history of other severe psychiatric disorders (eg, schizophrenia, bipolar disorder). 13. Score of the 9-question Patient Health Questionnaire (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. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre de recherche Clinique de Laval | Laval | Quebec |
Canada | GCP Research | Montreal | Quebec |
Georgia | "Clinic- LJ", LTD | Kutaisi | |
Georgia | LTD Clinic Rustavi | Rust'avi | |
Georgia | Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Internal Medicine and Medical Research | Tbilisi | |
Georgia | Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Multi-center Clinical Trials | Tbilisi | |
Georgia | Aleksandre Aladashvili Clinic LLC | Tbilisi | |
Georgia | Archangel St Michael Multiprofile Clinical Hospital Ltd | Tbilisi | |
Georgia | Georgian Dutch Hospital LLC | Tbilisi | |
Georgia | Israel-Georgia Research Clinic Helsicore, LTD | Tbilisi | |
Georgia | L. Managadze National Center of Urology, LTD | Tbilisi | |
Georgia | LTD "Adapt" | Tbilisi | |
Georgia | Ltd "Institute of Clinical Cardiology" | Tbilisi | |
Georgia | LTD Tbilisi Heart Center | Tbilisi | |
Georgia | National Institute of Endocrinology, LTD, | Tbilisi | |
Georgia | Tbilisi Heart and Vascular Clinic LTD | Tbilisi | |
Hungary | Diaverum Dialysis Centre of Baja and Nephrology Out-Patient Clinic of Baja St.Rokus Hospital | Baja | |
Hungary | DPC Hospital - Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases, 1st Department of Internal Medicine | Budapest | |
Hungary | University of Debrecen | Debrecen | |
Hungary | Flor Ferenc Hospital of Pest County | Kistarcsa | |
Hungary | Medifarma-98 Kft | Nyíregyháza | |
Israel | Haemek medical center | Afula | |
Israel | Barzilai Medical Center | Ashkelon | |
Israel | Wolfson medical center | H_olon | |
Israel | Rambam Health Care Campus \ Rambam Medical Center | Haifa | |
Israel | Hadassah Medical Center | Jerusalem | |
Israel | Meir Medical Center | Kfar Saba | |
Israel | Rabin Medical Center, Beilinson Campus | Petah tikva | |
Israel | Ziv Medical Center | Safed | |
Israel | Ziv Medical Center - Endocrinology Clinic | Safed | |
Mexico | Instituto de Diabetes Obesidad Y Nutricion , S.C. | Cuernavaca | |
Mexico | Cento de Investigacion Medica de Occidente, S.C. | Guadalajara | |
Mexico | Cento de Investigacion Medica de Occidente, S.C. | Guadalajara | |
Mexico | Centro de Investigación Médica y Reumatología S.C. | Guadalajara | |
Mexico | Medical Office | Guadalajara | |
Mexico | Unidad de Investigación Clinica y atencion Medica HEPA | Guadalajara | |
Mexico | Investigación Médica | Mérida | |
Mexico | St Lucas Clinical Research Center SA de CV | Mérida | |
Mexico | Clinica Integral del Paciente Diabético y Obeso | Mexico City | |
Mexico | Instituto Veracruzano en Investigacion Clínica S.C. | Veracruz | |
Serbia | Clinical Hospital Center Zemun | Belgrade | |
Serbia | General Hospital "Vršac" | Belgrade | |
Serbia | University Clincial Center of Serbia | Belgrade | |
Serbia | University of Kragujevac - Klinicki Centar "Kragujevac" | Kragujevac | |
Serbia | General Hospital Krusevac | Kruševac | |
Serbia | University Clinical Center Nis, Clinic of Nephrology | Niš | |
Serbia | University Clinical Center of Vojvodina | Novi Sad | |
Serbia | Healt Center Uzice,General Hospital | Užice | |
Serbia | Health Center Zajecar | Zajecar | |
United States | Northeast Clinical Research Center | Bethlehem | Pennsylvania |
United States | Research Physicians Network Alliance | Boca Raton | Florida |
United States | University of Vermont Medical Center | Burlington | Vermont |
United States | Research by Design, LLC | Chicago | Illinois |
United States | ALL Medical Research, LLC | Cooper City | Florida |
United States | North Texas Endocrine Center | Dallas | Texas |
United States | National Institute of Clinical Research, Inc. | Garden Grove | California |
United States | Physicians East, PA | Greenville | North Carolina |
United States | Biopharma Informatic, LLC | Houston | Texas |
United States | Clinical Research Consultants, LLC | Kansas City | Missouri |
United States | Knoxville Kidney Center, Pllc | Knoxville | Tennessee |
United States | Palm Research Center, Inc | Las Vegas | Nevada |
United States | South Florida Research Institute | Lauderdale Lakes | Florida |
United States | South Carolina Clinical Research LLC | Orangeburg | South Carolina |
United States | Linq Research, LLC | Pearland | Texas |
United States | Linq Research, LLC | Pearland | Texas |
United States | National Institute of Clinical Research, Inc - Pomona | Pomona | California |
United States | Endocrine and metabolic Consultants | Rockville | Maryland |
United States | Endocrine Research Solutions, Inc. | Roswell | Georgia |
United States | Central Coast Nephrology | Salinas | California |
United States | Clinical Advancement Center, PLLC | San Antonio | Texas |
United States | North American Research Institute | San Dimas | California |
United States | National Institute of Clinical Research, Inc - Upland | Upland | California |
Lead Sponsor | Collaborator |
---|---|
Inversago Pharma Inc. | Worldwide Clinical Trials |
United States, Canada, Georgia, Hungary, Israel, Mexico, Serbia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in UACR from baseline to W16 | Measure of UACR at W16 in comparison to baseline to evaluate the effect of INV-202 in participants with diabetic kidney disease (DKD) | 16 weeks | |
Secondary | Change in urine protein to creatinine ratio (UPCR) from baseline to W16 | Measure of UPCR at W16 in comparison to baseline to evaluate the effect of INV-202 in participants with diabetic kidney disease (DKD) | 16 weeks | |
Secondary | Change in eGFR using serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula from baseline to W16 | Measure of eGFR using creatinine and CKD-EPI formula at W16 in comparison to baseline to evaluate the effect of INV-202 in participants with diabetic kidney disease (DKD) | 16 weeks | |
Secondary | Change in eGFR using cystatin C and the CKD-EPI formula from baseline to W16 | Measure of eGFR using cystatin C and CKD-EPI formula at W16 in comparison to baseline to evaluate the effect of INV-202 in participants with diabetic kidney disease (DKD) | 16 weeks |
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