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NCT05099770PHASE3Recruiting

Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

Prokidney

Start Date

1/5/2022

Completion Date

12/1/2029

Summary

The purpose of this study is to assess the safety and efficacy of up to 2 REACT/rilparencel injections in participants with T2DM and CKD.

Detailed Description

Randomized multi-center, blinded intervention, two cohort, study whereby eligible participants will be randomized 1:1, prior to kidney biopsy, to 1 of 2 cohorts. Cohort 1 participants will have scripted sham procedures that mimic the sounds and activities of biopsy, injection procedures, and evaluations as a control for Cohort 2 participants who will have a kidney biopsy followed with a rilparencel injection into the biopsied kidney, then, approximately 12 weeks later with a second rilparencel injection into the contralateral kidney. All participants will be followed until the global trial end date is declared.

Eligibility Criteria

Age Range: 30 years to 80 years

Key Inclusion Criteria: 1. The participant is male or female, 30 to 80 years of age on the date of informed consent. 2. Documented diagnosis of type 2 diabetes mellitus (T2DM) and chronic kidney disease 3. Serum glycosylated hemoglobin (HbA1c) of 9.5% or lower at Screening. 4. Systolic blood pressure of ≤ 140 mm Hg and diastolic blood pressure of ≤ 90 mm Hg at Screening. 5. All participants should be strongly considered for treatment with sodium-glucose cotransporter 2 inhibitor (SGLT2i). 6. On a clinically relevant, maximally tolerated dose of an angiotensin converting-enzyme inhibitor (ACEI) OR an angiotensin receptor blocker (ARB), unless not tolerated or contraindicated. 7. Participant agrees and is able to refrain from using therapies that may increase bleeding risk for the specified pre-procedure and post-procedure durations. 8. Participant is willing and able to cooperate with all aspects of the protocol and provide signed informed consent. Key Exclusion Criteria: 1. The participant has a history of type 1 diabetes mellitus. 2. The participant has a history of renal transplantation or other organ transplantation 3. The participant has any other known underlying cause of kidney disease 4. History of acute kidney injury or major surgery within 3 months prior to the Screening Visit. 5. Myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before randomization, or a revascularization procedure is planned during the trial. 6. Current or history of heart failure of New York Heart Association (NYHA) Class IV cardiac disease. 7. History of exclusionary malignancy within the past 3 years prior to Screening 8. Documented clinically significant liver disease, including acute or chronic hepatitis B or hepatitis C. 9. Known infection with HIV, active syphilis, or other unresolved active genitourinary infection, or active tuberculosis requiring treatment at Screening. 10. Immunocompromised condition or condition requiring chronic immunosuppressive agents, including individuals treated for chronic glomerulonephritis, within 3 months of signing ICF. 11. Has had a recent bleeding event or a known bleeding disorder(s) or increased risk of either thromboembolism or bleeding. 12. Kidney imaging reveals contraindications for undergoing biopsy or rilparencel injection 13. Maintained on any anticoagulant agents 14. History of anaphylactic or severe systemic reaction(s) to blood transfusions, Dextran 40, or bovine products, or contraindication(s) to above products due to medical reasons or participant preference. 15. History of severe systemic reaction(s) or any contraindication to local anesthetics or sedatives. 16. Use of an investigational product or device within 12 weeks prior to Randomization or previous treatment with rilparencel. 17. Participant's health status would, in the judgement of the Investigator, be jeopardized by participating in the study.

Interventions

BIOLOGICAL

Renal Autologous Cell Therapy (REACT/ rilparencel)

PROCEDURE

Sham Comparator

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Conditions

Type 2 Diabetes MellitusChronic Kidney Diseases

Locations

Nephrology Consultants

Huntsville, Alabama 35805

United States

University of Arizona

Tucson, Arizona 85724

United States

Amicis Research Center

Beverly Hills, California 90211

United States

Paradise Clinical Research Group LLC

Glendora, California 91741

United States

Kidney Consultants Medical Group

Granada Hills, California 91344

United States

IMD Clinical Trials

Huntington Park, California 90255

United States

Advanced Medical Research, LLC

Lakewood, California 90712

United States

Medicine and Nephrology Associates

Los Alamitos, California 90720

United States

Academic Medical Research Institute

Los Angeles, California 90022

United States

Southern California Hospital

Los Angeles, California 90095

United States

Allameh Medical Corporation

Mission Viejo, California 92691

United States

Golden Pacific Nephrology Medical Clinic Inc

Monterey Park, California 91755

United States

Northridge Kidney Care Center

Northridge, California 91324

United States

Valley Renal Medical Group

Northridge, California 91324

United States

Valley Clinical Trials

Northridge, California 91325

United States

Integrity Medical Discovery

Pico Rivera, California 90660

United States

National Institute of Clinical Research

Pomona, California 91768

United States

Nephrology Associates Medical Group

Riverside, California 92505

United States

UC Davis Medical Group GI Unit

Sacramento, California 95817

United States

North America Research Institute

San Dimas, California 91773

United States

Henry Mayo Newhall Hospital

Valencia, California 91355

United States

Nephrology Associates PA

Newark, Delaware 19713

United States

West Broward Research Institute

Coral Springs, Florida 33313

United States

Florida Kidney Physicians

Fort Lauderdale, Florida 33316

United States

South Fort Lauderdale Nephrology

Fort Lauderdale, Florida 33316

United States

University of Florida

Gainesville, Florida 32608

United States

Mayo Clinic

Jacksonville, Florida 32224

United States

Ethos Palm Beach

Loxahatchee Groves, Florida 33470

United States

Global Clinix, LLC

Miami, Florida 33155

United States

Professional Research Center, Inc.

Miami, Florida 33172

United States

New Phase Clinical Trials

Miami Beach, Florida 33140

United States

Infigo Clinical Research

Sanford, Florida 32771

United States

Genesis Clinical Research

Tampa, Florida 33603

United States

American Clinical Trials

Acworth, Georgia 30101

United States

Wellstar Health System

Augusta, Georgia 30912

United States

Boise Kidney and Hypertension PLLC

Boise, Idaho 83706

United States

Care Institute

Chubbuck, Idaho 83202

United States

Insight Hospital & Medical Center Chicago

Chicago, Illinois 60616

United States

The University of Chicago Medical Center

Chicago, Illinois 60637

United States

Indiana Nephrology

Fishers, Indiana 46037

United States

Fresenius Kidney Care Mishawaka

Mishawaka, Indiana 46545

United States

University of Iowa

Iowa City, Iowa 52242

United States

Nephrology Associates of Lexington

Lexington, Kentucky 40504

United States

LSU Health Sciences Center

Shreveport, Louisiana 71103

United States

Washington Nephrology Associates

Takoma Park, Maryland 20854

United States

Holyoke Medical Center

Springfield, Massachusetts 01107

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Nephrology Center, PC

Kalamazoo, Michigan 49007

United States

St. Clair Nephrology Research

Roseville, Michigan 48066

United States

Southwest MS Nephrology

Brookhaven, Mississippi 39601

United States

Nephrology Associates

Columbus, Mississippi 39705

United States

Nephrology and Hypertension Associates

Tupelo, Mississippi 38801

United States

Saint Louis University

St Louis, Missouri 63110

United States

Nevada Kidney Disease & Hypertension Center

Las Vegas, Nevada 89052

United States

Seacoast Kidney & Hypertension Specialists

Portsmouth, New Hampshire 03801

United States

NYU Langone

New York, New York 10017

United States

ICAHN School of Medicine at Mount Sinai

New York, New York 10029

United States

Jacobi Medical Center

The Bronx, New York 10461

United States

UNC Chapel Hill

Chapel Hill, North Carolina 27514

United States

Lifespan Clinical Research Center

East Providence, Rhode Island 02915

United States

Rhode Island Hospital

Providence, Rhode Island 02903

United States

Dunes Clinical Research

Dakota Dunes, South Dakota 57049

United States

Knoxville Kidney Center

Knoxville, Tennessee 37923

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Pioneer Research Solutions, Inc.

Cypress, Texas 77429

United States

Texas Tech Health Sciences

El Paso, Texas 79905

United States

Texas Tech University Health

El Paso, Texas 79905

United States

Plaza Nephrology

Houston, Texas 77004

United States

Biopharma Informatic, LLC

Houston, Texas 77043

United States

Prolato Clinical Research Center

Houston, Texas 77054

United States

Clinical Research Strategies, Inc

Houston, Texas 77090

United States

United Memorial Medical Center

Houston, Texas 77091

United States

Clinical Advancement Center, PLLC

San Antonio, Texas 78212

United States

University Health System

San Antonio, Texas 78229

United States

Prolato Clinical Research Center - Sugar Land

Sugar Land, Texas 77479

United States

Renal Physicians of Montgomery County

The Woodlands, Texas 77384

United States

Salem VA Medical Center

Salem, Virginia 24153

United States

Providence Medical Research Ctr

Spokane, Washington 99204

United States

University of Wisconsin-Madison

Madison, Wisconsin 53792

United States

St. George Hospital

Kogarah, New South Wales 2217

Australia

Lakeridge Health Corporation-Oshawa

Oshawa, Ontario

Canada

"Ignacio Chavez" National Cardiology Institute

Tlalpan, Mexico City 14080

Mexico

National Institute of Medical Sciences and Nutrition Salvador Zubiran

Tlalpan, Mexico City 14080

Mexico

Torre Medica San Lucas

Ponce, 00716

Puerto Rico

San Miguel Medical

Trujillo Alto, 00976

Puerto Rico

Far Eastern Memorial Hospital

New Taipei City, 220

Taiwan

Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

New Taipei City, 23561

Taiwan

China Medical University Hospital

Taichung, 40447

Taiwan

Taichung Veterans General Hospital

Taichung,

Taiwan

National Taiwan University Hospital

Taipei, 100225

Taiwan

Taipei Medical University Hospital

Taipei, 110

Taiwan

Tri-Service General Hospital

Taipei, 11490

Taiwan

Taipei Municipal Wanfang Hospital Managed by Taipei Medical University

Taipei, 116

Taiwan

Taipei Municipal Wanfang Hospital

Taipei,

Taiwan

Royal London Hospital

London, E1 1FR

United Kingdom