Actively Recruiting

Phase 3
Age: 30Years - 80Years
All Genders
NCT05099770

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

Led by Prokidney · Updated on 2026-03-23

685

Participants Needed

95

Research Sites

412 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 30Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be male or female, aged 30 to 80 years at the time of consent
  • Diagnosed with type 2 diabetes mellitus and chronic kidney disease
  • Serum glycosylated hemoglobin (HbA1c) of 9.5% or lower at screening
  • Systolic blood pressure of 140 mm Hg or less and diastolic blood pressure of 90 mm Hg or less at screening
  • Participants should be strongly considered for treatment with sodium-glucose cotransporter 2 inhibitor (SGLT2i)
  • 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
  • Willing and able to refrain from therapies that might increase bleeding risk around the procedure times
  • Able and willing to cooperate with all study procedures and provide informed consent
Not Eligible

You will not qualify if you...

  • History of type 1 diabetes mellitus
  • History of kidney transplant or other organ transplantation
  • Any other known cause of kidney disease apart from diabetic kidney disease
  • Acute kidney injury or major surgery within 3 months before screening
  • Recent myocardial infarction, unstable angina, revascularization, or stroke within 12 weeks before randomization, or planned revascularization during the trial
  • Current or past heart failure classified as New York Heart Association Class IV
  • History of certain cancers within 3 years before screening
  • Significant liver disease including acute or chronic hepatitis B or C
  • Known infection with HIV, active syphilis, unresolved genitourinary infection, or active tuberculosis requiring treatment at screening
  • Immunocompromised condition or use of chronic immunosuppressive agents within 3 months before consent
  • Recent bleeding events, bleeding disorders, or increased risk of blood clots or bleeding
  • Kidney imaging showing inability to safely undergo biopsy or injection
  • Use of anticoagulant medications
  • History of severe allergic reactions to blood transfusions, Dextran 40, bovine products, local anesthetics, or sedatives
  • Use of investigational products or devices within 12 weeks before randomization or prior treatment with rilparencel
  • Any health condition judged by the investigator to make participation unsafe

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 95 locations

1

Nephrology Consultants

Huntsville, Alabama, United States, 35805

Actively Recruiting

2

University of Arizona

Tucson, Arizona, United States, 85724

Actively Recruiting

3

Amicis Research Center

Beverly Hills, California, United States, 90211

Active, Not Recruiting

4

Paradise Clinical Research Group LLC

Glendora, California, United States, 91741

Withdrawn

5

Kidney Consultants Medical Group

Granada Hills, California, United States, 91344

Active, Not Recruiting

6

IMD Clinical Trials

Huntington Park, California, United States, 90255

Actively Recruiting

7

Advanced Medical Research, LLC

Lakewood, California, United States, 90712

Actively Recruiting

8

Medicine and Nephrology Associates

Los Alamitos, California, United States, 90720

Actively Recruiting

9

Academic Medical Research Institute

Los Angeles, California, United States, 90022

Actively Recruiting

10

Southern California Hospital

Los Angeles, California, United States, 90095

Actively Recruiting

11

Allameh Medical Corporation

Mission Viejo, California, United States, 92691

Completed

12

Golden Pacific Nephrology Medical Clinic Inc

Monterey Park, California, United States, 91755

Actively Recruiting

13

Northridge Kidney Care Center

Northridge, California, United States, 91324

Active, Not Recruiting

14

Valley Renal Medical Group

Northridge, California, United States, 91324

Actively Recruiting

15

Valley Clinical Trials

Northridge, California, United States, 91325

Actively Recruiting

16

Integrity Medical Discovery

Pico Rivera, California, United States, 90660

Active, Not Recruiting

17

National Institute of Clinical Research

Pomona, California, United States, 91768

Actively Recruiting

18

Nephrology Associates Medical Group

Riverside, California, United States, 92505

Actively Recruiting

19

UC Davis Medical Group GI Unit

Sacramento, California, United States, 95817

Actively Recruiting

20

North America Research Institute

San Dimas, California, United States, 91773

Actively Recruiting

21

Henry Mayo Newhall Hospital

Valencia, California, United States, 91355

Active, Not Recruiting

22

Nephrology Associates PA

Newark, Delaware, United States, 19713

Actively Recruiting

23

West Broward Research Institute

Coral Springs, Florida, United States, 33313

Active, Not Recruiting

24

Florida Kidney Physicians

Fort Lauderdale, Florida, United States, 33316

Completed

25

South Fort Lauderdale Nephrology

Fort Lauderdale, Florida, United States, 33316

Actively Recruiting

26

University of Florida

Gainesville, Florida, United States, 32608

Actively Recruiting

27

Mayo Clinic

Jacksonville, Florida, United States, 32224

Actively Recruiting

28

Ethos Palm Beach

Loxahatchee Groves, Florida, United States, 33470

Actively Recruiting

29

Global Clinix, LLC

Miami, Florida, United States, 33155

Actively Recruiting

30

Professional Research Center, Inc.

Miami, Florida, United States, 33172

Actively Recruiting

31

New Phase Clinical Trials

Miami Beach, Florida, United States, 33140

Actively Recruiting

32

Infigo Clinical Research

Sanford, Florida, United States, 32771

Actively Recruiting

33

Genesis Clinical Research

Tampa, Florida, United States, 33603

Completed

34

American Clinical Trials

Acworth, Georgia, United States, 30101

Terminated

35

Wellstar Health System

Augusta, Georgia, United States, 30912

Actively Recruiting

36

Boise Kidney and Hypertension PLLC

Boise, Idaho, United States, 83706

Actively Recruiting

37

Care Institute

Chubbuck, Idaho, United States, 83202

Actively Recruiting

38

Insight Hospital & Medical Center Chicago

Chicago, Illinois, United States, 60616

Actively Recruiting

39

The University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Active, Not Recruiting

40

Indiana Nephrology

Fishers, Indiana, United States, 46037

Actively Recruiting

41

Fresenius Kidney Care Mishawaka

Mishawaka, Indiana, United States, 46545

Actively Recruiting

42

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

43

Nephrology Associates of Lexington

Lexington, Kentucky, United States, 40504

Actively Recruiting

44

LSU Health Sciences Center

Shreveport, Louisiana, United States, 71103

Actively Recruiting

45

Washington Nephrology Associates

Takoma Park, Maryland, United States, 20854

Completed

46

Holyoke Medical Center

Springfield, Massachusetts, United States, 01107

Suspended

47

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

48

Nephrology Center, PC

Kalamazoo, Michigan, United States, 49007

Actively Recruiting

49

St. Clair Nephrology Research

Roseville, Michigan, United States, 48066

Suspended

50

Southwest MS Nephrology

Brookhaven, Mississippi, United States, 39601

Actively Recruiting

51

Nephrology Associates

Columbus, Mississippi, United States, 39705

Actively Recruiting

52

Nephrology and Hypertension Associates

Tupelo, Mississippi, United States, 38801

Actively Recruiting

53

Saint Louis University

St Louis, Missouri, United States, 63110

Withdrawn

54

Nevada Kidney Disease & Hypertension Center

Las Vegas, Nevada, United States, 89052

Withdrawn

55

Seacoast Kidney & Hypertension Specialists

Portsmouth, New Hampshire, United States, 03801

Actively Recruiting

56

NYU Langone

New York, New York, United States, 10017

Actively Recruiting

57

ICAHN School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

58

Jacobi Medical Center

The Bronx, New York, United States, 10461

Actively Recruiting

59

UNC Chapel Hill

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

60

Lifespan Clinical Research Center

East Providence, Rhode Island, United States, 02915

Actively Recruiting

61

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Withdrawn

62

Dunes Clinical Research

Dakota Dunes, South Dakota, United States, 57049

Actively Recruiting

63

Knoxville Kidney Center

Knoxville, Tennessee, United States, 37923

Actively Recruiting

64

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

65

Pioneer Research Solutions, Inc.

Cypress, Texas, United States, 77429

Actively Recruiting

66

Texas Tech Health Sciences

El Paso, Texas, United States, 79905

Completed

67

Texas Tech University Health

El Paso, Texas, United States, 79905

Active, Not Recruiting

68

Plaza Nephrology

Houston, Texas, United States, 77004

Actively Recruiting

69

Biopharma Informatic, LLC

Houston, Texas, United States, 77043

Suspended

70

Prolato Clinical Research Center

Houston, Texas, United States, 77054

Actively Recruiting

71

Clinical Research Strategies, Inc

Houston, Texas, United States, 77090

Actively Recruiting

72

United Memorial Medical Center

Houston, Texas, United States, 77091

Actively Recruiting

73

Clinical Advancement Center, PLLC

San Antonio, Texas, United States, 78212

Actively Recruiting

74

University Health System

San Antonio, Texas, United States, 78229

Actively Recruiting

75

Prolato Clinical Research Center - Sugar Land

Sugar Land, Texas, United States, 77479

Actively Recruiting

76

Renal Physicians of Montgomery County

The Woodlands, Texas, United States, 77384

Actively Recruiting

77

Salem VA Medical Center

Salem, Virginia, United States, 24153

Actively Recruiting

78

Providence Medical Research Ctr

Spokane, Washington, United States, 99204

Actively Recruiting

79

University of Wisconsin-Madison

Madison, Wisconsin, United States, 53792

Actively Recruiting

80

St. George Hospital

Kogarah, New South Wales, Australia, 2217

Withdrawn

81

Lakeridge Health Corporation-Oshawa

Oshawa, Ontario, Canada

Withdrawn

82

"Ignacio Chavez" National Cardiology Institute

Tlalpan, Mexico City, Mexico, 14080

Actively Recruiting

83

National Institute of Medical Sciences and Nutrition Salvador Zubiran

Tlalpan, Mexico City, Mexico, 14080

Actively Recruiting

84

Torre Medica San Lucas

Ponce, Puerto Rico, 00716

Actively Recruiting

85

San Miguel Medical

Trujillo Alto, Puerto Rico, 00976

Actively Recruiting

86

Far Eastern Memorial Hospital

New Taipei City, Taiwan, 220

Suspended

87

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

New Taipei City, Taiwan, 23561

Actively Recruiting

88

China Medical University Hospital

Taichung, Taiwan, 40447

Active, Not Recruiting

89

Taichung Veterans General Hospital

Taichung, Taiwan

Actively Recruiting

90

National Taiwan University Hospital

Taipei, Taiwan, 100225

Actively Recruiting

91

Taipei Medical University Hospital

Taipei, Taiwan, 110

Actively Recruiting

92

Tri-Service General Hospital

Taipei, Taiwan, 11490

Actively Recruiting

93

Taipei Municipal Wanfang Hospital Managed by Taipei Medical University

Taipei, Taiwan, 116

Active, Not Recruiting

94

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

Actively Recruiting

95

Royal London Hospital

London, United Kingdom, E1 1FR

Withdrawn

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Research Team

P

ProKidney Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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