A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes

Last updated: March 17, 2025
Sponsor: Bayer
Overall Status: Completed

Phase

2

Condition

Kidney Failure

Focal Segmental Glomerulosclerosis

Kidney Disease

Treatment

Placebo

Empagliflozin Placebo

Empagliflozin

Clinical Study ID

NCT05254002
21839
2023-506981-30-00
2021-003037-11
  • Ages > 18
  • All Genders

Study Summary

Finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to play a role in CKD.

Empagliflozin lowers blood sugar levels by increasing the excretion of glucose from the blood into the urine.

In this study, the researchers want to learn how well the combination of finerenone and empagliflozin helps to slow down the worsening of the participants' kidney function compared to either treatment alone. For this, the level of protein in the urine will be measured. The investigators also want to know how safe the combination is compared to either treatment alone.

Depending on the treatment group, the participants will either take the combination of finerenone and empagliflozin, or finerenone together with a placebo, or empagliflozin together with a placebo, once a day as tablets by mouth. A placebo looks like a treatment but does not have any medicine in it. Importantly, the participants will also continue to take their other current medicine for CKD and T2D.

The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, participants will visit the study site 7 times.

The study team will:

  • collect blood and urine samples

  • check the participants' vital signs

  • do a physical examination including height and weight

  • check the participants' heart health by using an electrocardiogram (ECG)

  • monitor the participants' blood pressure

  • ask the participants questions about how they are feeling and what adverse events they may be having An adverse event is any problem that happens during the trial. Doctors keep track of all events that happen in trials, even if they do not think the events might be related to the study treatments.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant with a clinical diagnosis of chronic kidney disease (CKD) and thefollowing:

  • In Part A: eGFR 40-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75ml/min/1.73m^2) using Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) formula at screening visit and at least one historical value of eGFR <60mL/min/1.73 m^2 within 3 months or have a registered diagnosis of CKD.

  • In Part B: eGFR 30-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75ml/min/1.73m^2) using CKD-EPI formula at screening visit and at least onehistorical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have aregistered diagnostic of CKD.

  • 100 ≤UACR <5000 mg/g at screening visit (mean value from 3 morning voidsamples) and documentation of albuminuria/proteinuria (quantitative orsemi-quantitative measurement) in the participant's medical records at least 3months prior to screening

  • Participant with type 2 diabetes (T2D) as defined by the American DiabetesAssociation (ADA 2021), with glycated hemoglobin (HbA1c) at screening <11%.

  • Participant treated with the clinically maximum tolerated dose, as per investigatorjudgment, of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptorblocker (ARB), but not both, for more than 1 month at screening visit.

Exclusion

Exclusion Criteria:

  • Participants with type 1 diabetes (T1D).

  • Participant with hepatic insufficiency classified as Child-Pugh C.

  • Participant with blood pressure at Day 1 visit (Visit 2) higher than 160 systolicblood pressure (SBP) or 100 diastolic blood pressure (DBP) or SBP lower than 90mmHg.

  • Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot bediscontinued at least 8 weeks prior to the screening visit and during studyintervention treatment.

  • Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g.,eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassiumsupplements, a potassium sparing diuretic (e.g., amiloride, triamterene), apotassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) whichcannot be discontinued at least 8 weeks prior to the screening visit and duringstudy intervention treatment.

  • Participants currently treated or who were treated with Finerenone (Kerendia©)within 8 weeks prior to the screening visit.

  • Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening visit (central laboratory value).

Study Design

Total Participants: 1664
Treatment Group(s): 7
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 23, 2022
Estimated Completion Date:
March 14, 2025

Connect with a study center

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    Lodelinsart, Hainaut 6042
    Belgium

    Site Not Available

  • Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst

    Aalst, Oost-vlaanderen 9300
    Belgium

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  • UZ Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • AZ St-Lucas Campus St-Lucas

    Gent, 9000
    Belgium

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  • UZ Gent

    Gent, 9000
    Belgium

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  • Regionaal ZH Jan Yperman Campus Mariaziekenhuis

    Ieper, 8900
    Belgium

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  • AZ Groeninge Campus Kennedylaan

    Kortrijk, 8500
    Belgium

    Site Not Available

  • UZ Leuven Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • AZ Delta

    Roeselare, 8800
    Belgium

    Site Not Available

  • LMC Manna Research - Calgary

    Calgary, Alberta T2H 2G4
    Canada

    Site Not Available

  • LMC Manna Research - Barrie

    Barrie, Ontario L4N 7L3
    Canada

    Site Not Available

  • LMC Manna Research - Brampton

    Brampton, Ontario L6S 0C6
    Canada

    Site Not Available

  • LMC Manna Research - Thornhill

    Concord, Ontario L4K 4M2
    Canada

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  • LMC Manna Research - Etobicoke

    Etobicoke, Ontario M9R 4E1
    Canada

    Site Not Available

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    Hamilton, Ontario L8M 1K7
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    Kitchener, Ontario N2H 5Z8
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    Mississauga, Ontario L5H4K9
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    Nepean, Ontario K2J 0V2
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    Pune, 411001
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    Secunderabad, 500003
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    Vadodara,
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    Afula, 1834111
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    Holon, 5822012
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    Petach Tikva, 4941492
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    Tel Aviv, 6937947
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    Zefat, 1311001
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  • A.O.U. di Parma

    Parma, Emilia-Romagna 43126
    Italy

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    Parma, Emilia-Romagna 43126
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    Chiavari, Liguria 16043
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    Genova, Liguria 16043
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    Bergamo, Lombardia 24127
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    Bergamo, Lombardia 24127
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    Milano, Lombardia 20024
    Italy

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    Milano, Lombardia 20142
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  • Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Paolo - Gestione integrata della malattia Diabetica

    Milano, Lombardia 20142
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  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milano, Lombardia 20122
    Italy

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    Milano, Lombardia 20122
    Italy

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  • Ospedale San Raffaele s.r.l.

    Milano, Lombardia 20132
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    Rho, Lombardia 20017
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    Rho, Lombardia 20017
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    Orbassano, Piemonte 10043
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    Torino, Piemonte 10043
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  • IRCCS Casa Sollievo della Sofferenza

    Foggia, Puglia 71013
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    San Giovanni Rotondo, Puglia 71013
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    Olbia, Sardegna 07026
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    Sassari, Sardegna 7026
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    Catania, Sicilia 95124
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    Pisa, Toscana 56126
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    Pisa, Toscana 56124
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    Verona, Veneto 37126
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  • Azienda Ospedaliera Universitaria Integrata Verona_Borgo Roma - Endocrinologia, Diabetologia e Malattie del Metabolismo

    Verona, Veneto 37134
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  • Universita Degli Studi "Gabriele d'Annunzio" - Chieti - Centro Scienze dell'Invecchiamento (Centro Studi Sull'Invecchiamento

    Chieti, 66100
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  • Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia

    Chieti, 66100
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  • Many Locations

    Multiple Locations,
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  • Saiseikai Matsuyama Hospital

    Matsuyama, Ehime 791-8026
    Japan

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    Chikushino, Fukuoka 818-8502
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    Kitakyushu, Fukuoka 807-0857
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    Kitakyushu, Fukuoka 802-8555
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    Obihiro, Hokkaido 080-0848
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    Naka, Ibaraki 311-0113
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    Hakusan, Ishikawa 924-8588
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    Seongnam-si, Gyeonggido 13620
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    Seoul, 7442
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    A Coruna, A Coruña 15006
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    Ferrol, A Coruña 15405
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    Alcalá de Henares, Madrid 28805
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    Marbella, Malaga 29603
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    Castilleja de la Cuesta, Sevilla 41950
    Spain

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    A Coruña, 15006
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    Barcelona, 08035
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    Barcelona, 8023
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    Barcelona, 08023
    Spain

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    Granada, 18012
    Spain

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    Granada, 18014
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    Madrid, 28040
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    Madrid, 28041
    Spain

    Site Not Available

  • Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department

    Majadahonda, 28222
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department

    Malaga, 29010
    Spain

    Site Not Available

  • Many Locations

    Multiple Locations,
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Universitario Dr. Peset

    Valencia, 46017
    Spain

    Site Not Available

  • Changhua Christian Hospital

    Changhua, 50006
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital Kaohsiung

    Kaohsiung, 833
    Taiwan

    Site Not Available

  • Many Locations

    Multiple Locations,
    Taiwan

    Site Not Available

  • Far Eastern Memorial Hospital

    New Taipei City, 220
    Taiwan

    Active - Recruiting

  • Far Eastern Memorial Hospital | Nephrology Department

    New Taipei City, 220
    Taiwan

    Site Not Available

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, 23561
    Taiwan

    Site Not Available

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City,, 23561
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 404327
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Desert Clinical Research - CCT Research

    Mesa, Arizona 85213
    United States

    Site Not Available

  • Southwest Kidney Institute, PLC

    Surprise, Arizona 85374
    United States

    Site Not Available

  • Academic Medical Research Institute

    Los Angeles, California 90022
    United States

    Site Not Available

  • Nola Care Clinical Research

    Los Angeles, California 70006
    United States

    Site Not Available

  • Northridge Hospital

    Northridge, California 91325
    United States

    Site Not Available

  • Olive View - UCLA Medical Center

    Sylmar, California 91342-1437
    United States

    Site Not Available

  • Touro University California

    Vallejo, California 94592
    United States

    Site Not Available

  • Chase Medical Research, LLC

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Florida Kidney Physicians

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Florida Kidney Physicians - Delray Beach Nephrology

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • East Coast Institute for Research, Inc. - Jacksonville

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • West Orange Endocrinology & Clinical Research

    Ocoee, Florida 34761-4547
    United States

    Site Not Available

  • Advent Health

    Orlando, Florida 32804
    United States

    Site Not Available

  • Innovative Research Institute

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida 33401-3430
    United States

    Site Not Available

  • Emory University School of Medicine

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Grady Memorial Hospital - Endocrinology

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Southeast Kidney Associates

    East Point, Georgia 30344
    United States

    Site Not Available

  • Meridian Clinical Research- Savannah

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Velocity Clinical Research - Savannah

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Cook County Health and Hospital System

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale

    Hinsdale, Illinois 60521
    United States

    Site Not Available

  • Nephrology Associates Of Northern Illinois And Ind - Fort Wayne

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Versailles Family Medicine

    Versailles, Kentucky 40383
    United States

    Site Not Available

  • Nola Care Clinical Research

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Omega Clinical Research Center

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Dr Nowreen Haq Endocrinology Clinic

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • South Shore Nephrology

    Plymouth, Massachusetts 02360
    United States

    Site Not Available

  • Lake Michigan Nephrology

    Saint Joseph, Michigan 49085
    United States

    Site Not Available

  • Oakland Medical Center

    Troy, Michigan 48085
    United States

    Site Not Available

  • Clinical Research Consultants

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Kansas City VA Medical Center

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • Kansas City VA Medical Center - Endocrinology

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • St. Louis Heart & Vascular, PC

    Saint Louis, Missouri 63136
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Washington University School of Medicine in St. Louis

    Saint Louis, Missouri 63110-1010
    United States

    Site Not Available

  • Somnos Clinical Research

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Meridian Clinical Research- Norfolk

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • Healor Primary Care / CCT Research

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Santa Rosa Medical Centers of Nevada / CCT Research

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Circuit Clinical/Crystal Run

    Middletown, New York 10941
    United States

    Site Not Available

  • Carolina Clinical Research & Consulting at Triad Internal Medicine

    Asheboro, North Carolina 27203
    United States

    Active - Recruiting

  • Randolph Medical Associates

    Asheboro, North Carolina 27203
    United States

    Site Not Available

  • University of North Carolina Kidney Center

    Chapel Hill, North Carolina 27599-7155
    United States

    Site Not Available

  • Eastern Nephrology Associates - Greenville West

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Eastern Nephrology Associates / Greenville NC

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Blue Sky, MD/ Lamond Family Medicine

    Hendersonville, North Carolina 28792
    United States

    Site Not Available

  • Eastern Nephrology Associates - Kinston

    Kinston, North Carolina 28504
    United States

    Site Not Available

  • Velocity Clinical Research, Cincinnati

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Baliga Family Practice

    Columbus, Ohio 31904
    United States

    Site Not Available

  • Dunes Clinical Research LLC

    Dakota Dunes, South Dakota 57049
    United States

    Site Not Available

  • Oakland Medical Center

    Dakota Dunes, South Dakota 48085
    United States

    Site Not Available

  • DarSalud Care / LifeDOC Research

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • University of Tennessee Health Science Center

    Memphis, Tennessee 38163
    United States

    Site Not Available

  • Office of Osvaldo A. Brusco, MD

    Corpus Christi, Texas 78414-4173
    United States

    Site Not Available

  • Thyroid, Endocrinology, and Diabetes (TED) PA

    Dallas, Texas 75208-2362
    United States

    Site Not Available

  • DaVita Clinical Research - Texas

    El Paso, Texas 79935
    United States

    Site Not Available

  • DaVita Clinical Research- El Paso

    El Paso, Texas 79925
    United States

    Site Not Available

  • Global Kidney Center

    Houston, Texas 77008
    United States

    Site Not Available

  • Victorium Clinical Research

    Houston, Texas 77024-2593
    United States

    Site Not Available

  • North Texas Kidney Disease Associates, PLLC

    Lewisville, Texas 75057
    United States

    Site Not Available

  • Biopharma Informatic - McAllen, TX

    McAllen, Texas 78503
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    McAllen, Texas 78503
    United States

    Site Not Available

  • Clinical Advancement Center, PLLC

    San Antonio, Texas 78212
    United States

    Site Not Available

  • University of Texas Health Science Center

    San Antonio, Texas 78249
    United States

    Site Not Available

  • Olympus Family Medicine

    Salt Lake City, Utah 84117
    United States

    Site Not Available

  • Salem VA Medical Center

    Salem, Virginia 24153
    United States

    Active - Recruiting

  • Salem VA Medical Center - Endocrinology

    Salem, Virginia 24153
    United States

    Site Not Available

  • MultiCare Rockwood Clinic Diabetes & Endocrinology Center

    Spokane, Washington 99202
    United States

    Site Not Available

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