RecruitingPhase 3NCT05099770

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

A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease (REGEN-006)

Sponsor

Prokidney

Enrollment

685 participants

Start Date

Jan 5, 2022

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Diseases Type 2 Diabetes Mellitus

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.

Eligibility

Min Age: 30 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study (PROACT) is testing a new drug called REACT in people who have both type 2 diabetes and significant kidney disease, to see if it can slow the decline in kidney function. **You may be eligible if...** - You are between 30 and 80 years old - You have been diagnosed with type 2 diabetes AND chronic kidney disease caused by diabetes - Your kidney function (eGFR) is between 20–35 mL/min (reduced but not on dialysis) - You may also qualify if your eGFR is 30–35 and you have high protein in your urine - Your blood sugar (HbA1c) is 9.5% or below - Your blood pressure is 140/90 mmHg or lower **You may NOT be eligible if...** - You are on dialysis - Your blood sugar is very poorly controlled (HbA1c above 9.5%) - Your blood pressure is not adequately controlled - You have other causes of kidney disease unrelated to diabetes - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRenal Autologous Cell Therapy (REACT/ rilparencel)

Participants will have a kidney biopsy followed approximately12 weeks later with a rilparencel injection into the biopsied kidney, then, approximately 12 weeks later a rilparencel injection into their contralateral kidney.

PROCEDURESham Comparator

Participants will have sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The 2 injection/ sham procedures will occur approximately 12 weeks apart.

Locations(95)

Nephrology Consultants

Huntsville, Alabama, United States

University of Arizona

Tucson, Arizona, United States

Amicis Research Center

Beverly Hills, California, United States

Paradise Clinical Research Group LLC

Glendora, California, United States

Kidney Consultants Medical Group

Granada Hills, California, United States

IMD Clinical Trials

Huntington Park, California, United States

Advanced Medical Research, LLC

Lakewood, California, United States

Medicine and Nephrology Associates

Los Alamitos, California, United States

Academic Medical Research Institute

Los Angeles, California, United States

Southern California Hospital

Los Angeles, California, United States

Allameh Medical Corporation

Mission Viejo, California, United States

Golden Pacific Nephrology Medical Clinic Inc

Monterey Park, California, United States

Northridge Kidney Care Center

Northridge, California, United States

Valley Renal Medical Group

Northridge, California, United States

Valley Clinical Trials

Northridge, California, United States

Integrity Medical Discovery

Pico Rivera, California, United States

National Institute of Clinical Research

Pomona, California, United States

Nephrology Associates Medical Group

Riverside, California, United States

UC Davis Medical Group GI Unit

Sacramento, California, United States

North America Research Institute

San Dimas, California, United States

Henry Mayo Newhall Hospital

Valencia, California, United States

Nephrology Associates PA

Newark, Delaware, United States

West Broward Research Institute

Coral Springs, Florida, United States

Florida Kidney Physicians

Fort Lauderdale, Florida, United States

South Fort Lauderdale Nephrology

Fort Lauderdale, Florida, United States

University of Florida

Gainesville, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

Ethos Palm Beach

Loxahatchee Groves, Florida, United States

Global Clinix, LLC

Miami, Florida, United States

Professional Research Center, Inc.

Miami, Florida, United States

New Phase Clinical Trials

Miami Beach, Florida, United States

Infigo Clinical Research

Sanford, Florida, United States

Genesis Clinical Research

Tampa, Florida, United States

American Clinical Trials

Acworth, Georgia, United States

Wellstar Health System

Augusta, Georgia, United States

Boise Kidney and Hypertension PLLC

Boise, Idaho, United States

Care Institute

Chubbuck, Idaho, United States

Insight Hospital & Medical Center Chicago

Chicago, Illinois, United States

The University of Chicago Medical Center

Chicago, Illinois, United States

Indiana Nephrology

Fishers, Indiana, United States

Fresenius Kidney Care Mishawaka

Mishawaka, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Nephrology Associates of Lexington

Lexington, Kentucky, United States

LSU Health Sciences Center

Shreveport, Louisiana, United States

Washington Nephrology Associates

Takoma Park, Maryland, United States

Holyoke Medical Center

Springfield, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Nephrology Center, PC

Kalamazoo, Michigan, United States

St. Clair Nephrology Research

Roseville, Michigan, United States

Southwest MS Nephrology

Brookhaven, Mississippi, United States

Nephrology Associates

Columbus, Mississippi, United States

Nephrology and Hypertension Associates

Tupelo, Mississippi, United States

Saint Louis University

St Louis, Missouri, United States

Nevada Kidney Disease & Hypertension Center

Las Vegas, Nevada, United States

Seacoast Kidney & Hypertension Specialists

Portsmouth, New Hampshire, United States

NYU Langone

New York, New York, United States

ICAHN School of Medicine at Mount Sinai

New York, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Lifespan Clinical Research Center

East Providence, Rhode Island, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Dunes Clinical Research

Dakota Dunes, South Dakota, United States

Knoxville Kidney Center

Knoxville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Pioneer Research Solutions, Inc.

Cypress, Texas, United States

Texas Tech Health Sciences

El Paso, Texas, United States

Texas Tech University Health

El Paso, Texas, United States

Plaza Nephrology

Houston, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Prolato Clinical Research Center

Houston, Texas, United States

Clinical Research Strategies, Inc

Houston, Texas, United States

United Memorial Medical Center

Houston, Texas, United States

Clinical Advancement Center, PLLC

San Antonio, Texas, United States

University Health System

San Antonio, Texas, United States

Prolato Clinical Research Center - Sugar Land

Sugar Land, Texas, United States

Renal Physicians of Montgomery County

The Woodlands, Texas, United States

Salem VA Medical Center

Salem, Virginia, United States

Providence Medical Research Ctr

Spokane, Washington, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

St. George Hospital

Kogarah, New South Wales, Australia

Lakeridge Health Corporation-Oshawa

Oshawa, Ontario, Canada

"Ignacio Chavez" National Cardiology Institute

Tlalpan, Mexico City, Mexico

National Institute of Medical Sciences and Nutrition Salvador Zubiran

Tlalpan, Mexico City, Mexico

Torre Medica San Lucas

Ponce, Puerto Rico

San Miguel Medical

Trujillo Alto, Puerto Rico

Far Eastern Memorial Hospital

New Taipei City, Taiwan

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

New Taipei City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Taipei Municipal Wanfang Hospital Managed by Taipei Medical University

Taipei, Taiwan

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

Royal London Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05099770

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