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Phase 2 Study of INV-202 in Patients With Diabetic Kidney Disease

Primary Purpose

Diabetic Kidney Disease

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
INV-202
Placebo
Sponsored by
Inversago Pharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease focused on measuring Diabetic Kidney Disease, Type 1 diabetes mellitus (T1DM), Type 2 diabetes mellitus (T2DM)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical InvestigationsRecruiting
  • National Institute of Clinical Research, Inc - El MonteRecruiting
  • National Institute of Clinical Research, Inc.Recruiting
  • National Institute of Clinical Research, Inc - IrvineRecruiting
  • National Institute of Clinical Research, Inc - PomonaRecruiting
  • Central Coast NephrologyRecruiting
  • North American Research InstituteRecruiting
  • National Institute of Clinical Research, Inc - UplandRecruiting
  • National Institute of Clinical Research, Inc - VictorvilleRecruiting
  • Research Physicians Network AllianceRecruiting
  • ALL Medical Research, LLCRecruiting
  • South Florida Research InstituteRecruiting
  • Atlanta Diabetes AssociatesRecruiting
  • Endocrine Research Solutions, Inc.Recruiting
  • Research by Design, LLCRecruiting
  • Endocrine and metabolic ConsultantsRecruiting
  • Clinical Research Consultants, LLCRecruiting
  • Palm Research Center, IncRecruiting
  • Mountain Kidney & Hypertension AssociatesRecruiting
  • Physicians East, PARecruiting
  • Northeast Clinical Research CenterRecruiting
  • South Carolina Clinical Research LLCRecruiting
  • Knoxville Kidney Center, PllcRecruiting
  • North Texas Endocrine CenterRecruiting
  • Biopharma Informatic, LLCRecruiting
  • Linq Research, LLCRecruiting
  • Linq Research, LLCRecruiting
  • Clinical Advancement Center, PLLCRecruiting
  • University of Vermont Medical CenterRecruiting
  • Centre de recherche Clinique de LavalRecruiting
  • GCP ResearchRecruiting
  • "Clinic- LJ", LTDRecruiting
  • LTD Clinic RustaviRecruiting
  • L. Managadze National Center of Urology, LTDRecruiting
  • Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Internal Medicine and Medical ResearchRecruiting
  • Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Multi-center Clinical TrialsRecruiting
  • Archangel St Michael Multiprofile Clinical Hospital LtdRecruiting
  • Ltd "Institute of Clinical Cardiology"Recruiting
  • Tbilisi Heart and Vascular Clinic LTDRecruiting
  • Georgian Dutch Hospital LLCRecruiting
  • LTD Tbilisi Heart CenterRecruiting
  • Aleksandre Aladashvili Clinic LLCRecruiting
  • Israel-Georgia Research Clinic Helsicore, LTDRecruiting
  • LTD "Adapt"Recruiting
  • National Institute of Endocrinology, LTD,Recruiting
  • Diaverum Dialysis Centre of Baja and Nephrology Out-Patient Clinic of Baja St.Rokus HospitalRecruiting
  • DPC Hospital - Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases, 1st Department of Internal MedicineRecruiting
  • University of DebrecenRecruiting
  • Flor Ferenc Hospital of Pest CountyRecruiting
  • Medifarma-98 KftRecruiting
  • Haemek medical centerRecruiting
  • Barzilai Medical CenterRecruiting
  • Rambam Health Care Campus \ Rambam Medical CenterRecruiting
  • Wolfson medical centerRecruiting
  • Hadassah Medical CenterRecruiting
  • Meir Medical CenterRecruiting
  • Rabin Medical Center, Beilinson CampusRecruiting
  • Ziv Medical Center - Endocrinology ClinicRecruiting
  • Ziv Medical CenterRecruiting
  • Instituto de Diabetes Obesidad Y Nutricion , S.C.Recruiting
  • Centro de Investigación Médica y Reumatología S.C.Recruiting
  • Cento de Investigacion Medica de Occidente, S.C.Recruiting
  • Cento de Investigacion Medica de Occidente, S.C.Recruiting
  • Medical OfficeRecruiting
  • Unidad de Investigación Clinica y atencion Medica HEPARecruiting
  • Clinica Integral del Paciente Diabético y ObesoRecruiting
  • Investigación MédicaRecruiting
  • St Lucas Clinical Research Center SA de CVRecruiting
  • Instituto Veracruzano en Investigacion Clínica S.C.Recruiting
  • Clinical Hospital Center ZemunRecruiting
  • General Hospital "Vršac"Recruiting
  • University Clincial Center of SerbiaRecruiting
  • University of Kragujevac - Klinicki Centar "Kragujevac"Recruiting
  • General Hospital KrusevacRecruiting
  • University Clinical Center Nis, Clinic of NephrologyRecruiting
  • University Clinical Center of VojvodinaRecruiting
  • Healt Center Uzice,General HospitalRecruiting
  • Health Center ZajecarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

INV 202 10 mg

INV-202 25 mg

Placebo

Arm Description

INV-202 10 mg Arm

INV-202 25 mg Arm

Placebo Arm

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)

Full Information

First Posted
August 18, 2022
Last Updated
September 27, 2023
Sponsor
Inversago Pharma Inc.
Collaborators
Worldwide Clinical Trials
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1. Study Identification

Unique Protocol Identification Number
NCT05514548
Brief Title
Phase 2 Study of INV-202 in Patients With Diabetic Kidney Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
March 3, 2024 (Anticipated)
Study Completion Date
July 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inversago Pharma Inc.
Collaborators
Worldwide Clinical Trials

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed Description
This is a Phase 2, randomized, double-blind, placebo controlled, dose ranging, multicenter study designed to assess the efficacy, safety, tolerability, and pharmacokinetics of INV-202 for the treatment of adult participants with a diagnosis of DKD due to either Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) (diagnosed ≥1 year) who are on a stable anti diabetic medication regimen for ≥4 months prior with a HbA1c <9.5%. Approximately 240 participants (80/arm) will be randomized to 1 of 3 treatment arms in a 1:1:1 ratio: INV 202 10 mg, INV-202 25 mg, or placebo. The assigned study treatment will be taken once daily (QD), for 16 weeks. Due to the high expected screen failure rates, participants may be pre-screened at sites with an approved pre-screening ICF. Each participant will be allowed 1 retest during the screening period if they fail screening and 1 re-screening on a case by case basis with approval from the Worldwide medical monitors. Study participation will last approximately 22 weeks and includes a Screening Period (up to 4 weeks), a Study Treatment Period with 16 weeks of daily study treatment, and a Safety Follow-Up Visit consisting of a phone call 2 weeks after the End of Treatment Visit (Week [W]18) to allow reporting of any adverse events following withdrawal of the study drug. Any participant who withdraws before completing treatment will be requested to return for an Early Termination Visit, at which time the procedures normally scheduled for the W16 visit will be conducted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease
Keywords
Diabetic Kidney Disease, Type 1 diabetes mellitus (T1DM), Type 2 diabetes mellitus (T2DM)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INV 202 10 mg
Arm Type
Experimental
Arm Description
INV-202 10 mg Arm
Arm Title
INV-202 25 mg
Arm Type
Experimental
Arm Description
INV-202 25 mg Arm
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Arm
Intervention Type
Drug
Intervention Name(s)
INV-202
Other Intervention Name(s)
None applicable
Intervention Description
INV-202 is a new generation of CB1R antagonist developed by Inversago for potential use as a therapeutic method for the treatment of metabolic disorders, including nonalcoholic steatohepatitis, diabetes and its complications (such as DKD), and hypertriglyceridemia.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
None applicable
Intervention Description
Placebo Matching size and number of tablets
Primary Outcome Measure Information:
Title
Change in UACR from baseline to W16
Description
Measure of UACR at W16 in comparison to baseline to evaluate the effect of INV-202 in participants with diabetic kidney disease (DKD)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change in urine protein to creatinine ratio (UPCR) from baseline to W16
Description
Measure of UPCR at W16 in comparison to baseline to evaluate the effect of INV-202 in participants with diabetic kidney disease (DKD)
Time Frame
16 weeks
Title
Change in eGFR using serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula from baseline to W16
Description
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)
Time Frame
16 weeks
Title
Change in eGFR using cystatin C and the CKD-EPI formula from baseline to W16
Description
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)
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Participants taking finerenone (not required), on a stable dose for ≥4 months prior to randomization. Presence of albuminuria with a UACR >100 mg/g and <3000 mg/g at screening. 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. 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. Uncontrolled hypertension with measurements of systolic pressures >160 or diastolic measurements >100 at the Screening Visit. Active substance abuse including inhaled or injection drugs in the year prior to screening. Use of cannabis or cannabinoid containing compounds within 90 days prior to screening. Pregnancy, planned pregnancy, potential for pregnancy or unwillingness to use effective birth control during the trial, as well as breast feeding. Evidence of moderate to severe hepatic impairment as defined by Child's-Pugh B or C. Subjects with a history of significant psychiatric disorder, including but not limited to: Major depression within the last 2 years. Any history of a suicide attempt or suicidal ideation. Subjects with a history of other severe psychiatric disorders (eg, schizophrenia, bipolar disorder). Score of the 9-question Patient Health Questionnaire (PHQ-9) ≥15 at baseline. 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. QTc >500 msec at baseline. Any chronic medications started or changed within the past 3 months or at risk of needing to be changed during the study. Participants with a history of hyperthyroidism or other thyroid diseases. 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. Having taken any investigational compound within 30 days, or 5 half-lives of the drug, whichever is longer, before the Screening Visit.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Glenn Crater, MD
Phone
1-919-371-8411
Email
clinicalstrials-inquiries@inversago.com
First Name & Middle Initial & Last Name or Official Title & Degree
Karine Lalonde, MSc
Phone
438-300-2550
Email
clinicalstrials-inquiries@inversago.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Crater, MD
Organizational Affiliation
Inversago Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Medical Investigations
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Thrasher, Dr.
First Name & Middle Initial & Last Name & Degree
James Thrasher, Dr.
Facility Name
National Institute of Clinical Research, Inc - El Monte
City
El Monte
State/Province
California
ZIP/Postal Code
91733
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Katchman, Dr.
First Name & Middle Initial & Last Name & Degree
Neil Katchman, Dr.
Facility Name
National Institute of Clinical Research, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ban Doan, Dr.
First Name & Middle Initial & Last Name & Degree
Ban Doan, Dr.
Facility Name
National Institute of Clinical Research, Inc - Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Salem, Dr.
First Name & Middle Initial & Last Name & Degree
Christopher Salem, Dr.
Facility Name
National Institute of Clinical Research, Inc - Pomona
City
Pomona
State/Province
California
ZIP/Postal Code
91768
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mallu Reddy, Dr.
First Name & Middle Initial & Last Name & Degree
Mallu Reddy, Dr.
Facility Name
Central Coast Nephrology
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gopal Krishna, Dr.
First Name & Middle Initial & Last Name & Degree
Gopal Krishna, Dr.
Facility Name
North American Research Institute
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nitin Bhasin, Dr.
First Name & Middle Initial & Last Name & Degree
Nitin Bhasin, Dr.
Facility Name
National Institute of Clinical Research, Inc - Upland
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadi Ghassan, Dr.
First Name & Middle Initial & Last Name & Degree
Hadi Ghassan, Dr.
Facility Name
National Institute of Clinical Research, Inc - Victorville
City
Victorville
State/Province
California
ZIP/Postal Code
92395
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arash Milani, Dr.
First Name & Middle Initial & Last Name & Degree
Arash Milani, Dr,
Facility Name
Research Physicians Network Alliance
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jared Jaffe, Dr.
First Name & Middle Initial & Last Name & Degree
Jared Jaffe, Dr.
Facility Name
ALL Medical Research, LLC
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorena Lewy-Alterbaum, Dr.
First Name & Middle Initial & Last Name & Degree
Lorena Lewy-Alterbaum, Dr.
Facility Name
South Florida Research Institute
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard Martin, Dr.
First Name & Middle Initial & Last Name & Degree
Edouard Martin, Dr.
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce Bode, Dr.
First Name & Middle Initial & Last Name & Degree
Bruce Bode, Dr.
Facility Name
Endocrine Research Solutions, Inc.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Reed, Dr.
First Name & Middle Initial & Last Name & Degree
John Reed, Dr.
Facility Name
Research by Design, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60643
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
April Kennedy, Dr.
First Name & Middle Initial & Last Name & Degree
April Kennedy, Dr.
Facility Name
Endocrine and metabolic Consultants
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samer Nakhle, Dr.
First Name & Middle Initial & Last Name & Degree
Samer Nakhle, Dr.
Facility Name
Clinical Research Consultants, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Awad, Dr.
First Name & Middle Initial & Last Name & Degree
Ahmed Awad, Dr.
Facility Name
Palm Research Center, Inc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Rodbard, Dr.
First Name & Middle Initial & Last Name & Degree
Helena Rodbard, Dr.
Facility Name
Mountain Kidney & Hypertension Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nam Vo, Dr.
First Name & Middle Initial & Last Name & Degree
Nam Vo, Dr.
Facility Name
Physicians East, PA
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Warren, Dr.
First Name & Middle Initial & Last Name & Degree
Mark Warren, Dr.
Facility Name
Northeast Clinical Research Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Fels, Dr.
First Name & Middle Initial & Last Name & Degree
Eric Fels
Facility Name
South Carolina Clinical Research LLC
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moustafa Moustafa, Dr.
First Name & Middle Initial & Last Name & Degree
Moustafa Moustafa, Dr.
Facility Name
Knoxville Kidney Center, Pllc
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Newman, Dr.
First Name & Middle Initial & Last Name & Degree
George Newman, Dr.
Facility Name
North Texas Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Bressler, Dr.
First Name & Middle Initial & Last Name & Degree
Peter Bressler, Dr.
Facility Name
Biopharma Informatic, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Syed Hussain, Dr.
First Name & Middle Initial & Last Name & Degree
Syed Hussain, Dr.
Facility Name
Linq Research, LLC
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murtaza Mussaji, Dr.
First Name & Middle Initial & Last Name & Degree
Murtaza Mussaji, Dr.
Facility Name
Linq Research, LLC
City
Pearland
State/Province
Texas
ZIP/Postal Code
77854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kashif Siddiqui, Dr.
First Name & Middle Initial & Last Name & Degree
Kashif Siddiqui, Dr.
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Pergola, Dr.
First Name & Middle Initial & Last Name & Degree
Pablo Pergola, Dr.
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Solomon, Dr.
Facility Name
Centre de recherche Clinique de Laval
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Dumas, Dr.
First Name & Middle Initial & Last Name & Degree
Richard Dumas, Dr.
Facility Name
GCP Research
City
Montreal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Mazza, Dr.
First Name & Middle Initial & Last Name & Degree
Giuseppe Mazza, Dr.
Facility Name
"Clinic- LJ", LTD
City
Kutaisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zviad Svanadze, Dr.
First Name & Middle Initial & Last Name & Degree
Zviad Svanadze, Dr.
Facility Name
LTD Clinic Rustavi
City
Rust'avi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Mamasakhlisi, Dr.
First Name & Middle Initial & Last Name & Degree
Ana Mamasakhlisi, Dr.
Facility Name
L. Managadze National Center of Urology, LTD
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kokosha Pachulia, Dr.
First Name & Middle Initial & Last Name & Degree
Kokosha Pachulia, Dr.
Facility Name
Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Internal Medicine and Medical Research
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nana Okropiridze, Dr.
First Name & Middle Initial & Last Name & Degree
Nana Okropiridze, Dr.
Facility Name
Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Multi-center Clinical Trials
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medea Amashukeli, Dr.
First Name & Middle Initial & Last Name & Degree
Medea Amashukeli, Dr.
Facility Name
Archangel St Michael Multiprofile Clinical Hospital Ltd
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irakli Mukhashavria, Dr.
First Name & Middle Initial & Last Name & Degree
Irakli Mukhashavria, Dr.
Facility Name
Ltd "Institute of Clinical Cardiology"
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eka Skhiladze, Dr.
First Name & Middle Initial & Last Name & Degree
Eka Skhiladze, Dr.
Facility Name
Tbilisi Heart and Vascular Clinic LTD
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgi Parkosadze, Dr.
First Name & Middle Initial & Last Name & Degree
Parkosadze Giorgi, Dr.
Facility Name
Georgian Dutch Hospital LLC
City
Tbilisi
ZIP/Postal Code
0167
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sopio Puturidze, Dr.
First Name & Middle Initial & Last Name & Degree
Sopio Puturidze, Dr.
Facility Name
LTD Tbilisi Heart Center
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lika Tsutskiridze, Dr.
First Name & Middle Initial & Last Name & Degree
Lika Tsutskiridze, Dr.
Facility Name
Aleksandre Aladashvili Clinic LLC
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lela Beglarashvili, Dr.
First Name & Middle Initial & Last Name & Degree
Lela Beglarashvili, Dr.
Facility Name
Israel-Georgia Research Clinic Helsicore, LTD
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avtandil Tataradze, Dr.
First Name & Middle Initial & Last Name & Degree
Avtandil Tataradze, Dr.
Facility Name
LTD "Adapt"
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inga Ordenidze, Dr.
First Name & Middle Initial & Last Name & Degree
Inga Ordenidze, Dr.
Facility Name
National Institute of Endocrinology, LTD,
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elene Giorgadze, Dr.
First Name & Middle Initial & Last Name & Degree
Elene Giorgadze, Dr.
Facility Name
Diaverum Dialysis Centre of Baja and Nephrology Out-Patient Clinic of Baja St.Rokus Hospital
City
Baja
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katalin Magyar, Dr.
First Name & Middle Initial & Last Name & Degree
Katalin Magyar, Dr.
Facility Name
DPC Hospital - Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases, 1st Department of Internal Medicine
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andras Vertes, Dr.
First Name & Middle Initial & Last Name & Degree
Andras Vertes, Dr.
Facility Name
University of Debrecen
City
Debrecen
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denes Pall, Dr.
First Name & Middle Initial & Last Name & Degree
Denes Pall, Dr.
Facility Name
Flor Ferenc Hospital of Pest County
City
Kistarcsa
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Kirschner, Dr.
First Name & Middle Initial & Last Name & Degree
Robert Kirschner, Dr.
Facility Name
Medifarma-98 Kft
City
Nyíregyháza
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zsolt Imre Zilahi, Dr.
First Name & Middle Initial & Last Name & Degree
Zsolt Imre Zilahi, Dr.
Facility Name
Haemek medical center
City
Afula
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mazen Elias, Dr.
First Name & Middle Initial & Last Name & Degree
Mazen Elias, Dr.
Facility Name
Barzilai Medical Center
City
Ashkelon
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nomy Levin Iaina, Dr.
First Name & Middle Initial & Last Name & Degree
Nomy Levin Iaina, Dr.
Facility Name
Rambam Health Care Campus \ Rambam Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Zukermann, Dr.
First Name & Middle Initial & Last Name & Degree
Robert Zukermann, Dr.
Facility Name
Wolfson medical center
City
H̱olon
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio Wainstein, Dr.
First Name & Middle Initial & Last Name & Degree
Julio Wainstein, Dr.
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Genya Aharon Hananel, Dr.
First Name & Middle Initial & Last Name & Degree
Genya Aharon Hananel, Dr.
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irina Kenis, Dr.
First Name & Middle Initial & Last Name & Degree
Irina Kenis
Facility Name
Rabin Medical Center, Beilinson Campus
City
Petah tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rozen Zvi Benaya, Dr.
First Name & Middle Initial & Last Name & Degree
Rozen Zvi Benaya, Dr.
Facility Name
Ziv Medical Center - Endocrinology Clinic
City
Safed
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faiad Adawi, Dr.
First Name & Middle Initial & Last Name & Degree
Faiad Adawi, Dr.
Facility Name
Ziv Medical Center
City
Safed
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Majdi Halabi, Dr.
First Name & Middle Initial & Last Name & Degree
Majdi Halabi, Dr.
Facility Name
Instituto de Diabetes Obesidad Y Nutricion , S.C.
City
Cuernavaca
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leobardo Sauque Reyna, Dr.
First Name & Middle Initial & Last Name & Degree
Leobardo Sauque Reyna, Dr.
Facility Name
Centro de Investigación Médica y Reumatología S.C.
City
Guadalajara
ZIP/Postal Code
44130
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Enrique Aguilar Arreola
First Name & Middle Initial & Last Name & Degree
Jorge Enrique Aguilar Arreola
Facility Name
Cento de Investigacion Medica de Occidente, S.C.
City
Guadalajara
ZIP/Postal Code
45116
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilia Susana Pelayo Orozco
First Name & Middle Initial & Last Name & Degree
Emilia Susana Pelayo Orozco
Facility Name
Cento de Investigacion Medica de Occidente, S.C.
City
Guadalajara
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillermo Gonzalez Galvez, Dr.
First Name & Middle Initial & Last Name & Degree
Guillermo Gonzalez Galvez, Dr.
Facility Name
Medical Office
City
Guadalajara
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raul Alejandro Aguilar Orozco, Dr.
First Name & Middle Initial & Last Name & Degree
Raul Alejandro Aguilar Orozco, Dr.
Facility Name
Unidad de Investigación Clinica y atencion Medica HEPA
City
Guadalajara
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marisol Herrera Marmolejo, Dr.
First Name & Middle Initial & Last Name & Degree
Marisol Herrera Marmolejo, Dr.
Facility Name
Clinica Integral del Paciente Diabético y Obeso
City
Mexico City
ZIP/Postal Code
11850
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillermo Fanghänel Salmón
First Name & Middle Initial & Last Name & Degree
Guillermo Fanghänel Salmón
Facility Name
Investigación Médica
City
Mérida
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Medina Pech, Dr.
First Name & Middle Initial & Last Name & Degree
Carlos Medina Pech, Dr.
Facility Name
St Lucas Clinical Research Center SA de CV
City
Mérida
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruy David Arjona, Dr.
First Name & Middle Initial & Last Name & Degree
Ruy David Arjona, Dr.
Facility Name
Instituto Veracruzano en Investigacion Clínica S.C.
City
Veracruz
ZIP/Postal Code
91851
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Isela Luna Ceballos
First Name & Middle Initial & Last Name & Degree
Rosa Isela Luna Ceballos
Facility Name
Clinical Hospital Center Zemun
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Jemcov, Dr.
First Name & Middle Initial & Last Name & Degree
Tamara Jemcov, Dr.
Facility Name
General Hospital "Vršac"
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kosta Djordjev, Dr.
First Name & Middle Initial & Last Name & Degree
Kosta Djordjev
Facility Name
University Clincial Center of Serbia
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milan Radovic
First Name & Middle Initial & Last Name & Degree
Milan Radovic, Dr.
Facility Name
University of Kragujevac - Klinicki Centar "Kragujevac"
City
Kragujevac
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dejan Petrovic, Dr.
First Name & Middle Initial & Last Name & Degree
Dejan Dejan, Dr.
Facility Name
General Hospital Krusevac
City
Kruševac
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Branislav Branislav, Dr.
First Name & Middle Initial & Last Name & Degree
Branislav Andric, Dr.
Facility Name
University Clinical Center Nis, Clinic of Nephrology
City
Niš
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Branka Mitic, Dr.
First Name & Middle Initial & Last Name & Degree
Branka Mitic, Dr.
Facility Name
University Clinical Center of Vojvodina
City
Novi Sad
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Igor Mitic, Dr.
First Name & Middle Initial & Last Name & Degree
Igor Mitic, Dr.
Facility Name
Healt Center Uzice,General Hospital
City
Užice
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Snezana Milanovic, Dr.
First Name & Middle Initial & Last Name & Degree
Snezana Milanovic, Dr.
Facility Name
Health Center Zajecar
City
Zaječar
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Biserka Tirmenstajn Jankovic, Dr.
First Name & Middle Initial & Last Name & Degree
Biserka Tirmenstajn Jankovic, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase 2 Study of INV-202 in Patients With Diabetic Kidney Disease

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