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

August 10, 2026 updated by: Prokidney

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
685

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Mexico
    • Mexico City
      • Tlalpan, Mexico City, Mexico, 14080
        • "Ignacio Chavez" National Cardiology Institute
      • Tlalpan, Mexico City, Mexico, 14080
        • National Institute of Medical Sciences and Nutrition Salvador Zubiran
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Torre Medica San Lucas
      • Trujillo Alto, Puerto Rico, 00976
        • San Miguel Medical
  • Taiwan
      • New Taipei City, Taiwan, 220
        • Far Eastern Memorial Hospital
      • New Taipei City, Taiwan, 23561
        • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Taipei, Taiwan
        • Taipei Municipal Wanfang Hospital
      • Taipei, Taiwan, 110
        • Taipei Medical University Hospital
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital
      • Taipei, Taiwan, 100225
        • National Taiwan University Hospital
      • Taipei, Taiwan, 116
        • Taipei Municipal Wanfang Hospital Managed by Taipei Medical University
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Nephrology Consultants
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Beverly Hills, California, United States, 90211
        • Amicis Research Center
      • Granada Hills, California, United States, 91344
        • Kidney Consultants Medical Group
      • Huntington Park, California, United States, 90255
        • IMD Clinical Trials
      • Lakewood, California, United States, 90712
        • Advanced Medical Research, LLC
      • Los Alamitos, California, United States, 90720
        • Medicine and Nephrology Associates
      • Los Angeles, California, United States, 90022
        • Academic Medical Research Institute
      • Los Angeles, California, United States, 90095
        • Southern California Hospital
      • Mission Viejo, California, United States, 92691
        • Allameh Medical Corporation
      • Monterey Park, California, United States, 91755
        • Golden Pacific Nephrology Medical Clinic Inc
      • Northridge, California, United States, 91324
        • Valley Renal Medical Group
      • Northridge, California, United States, 91325
        • Valley Clinical Trials
      • Northridge, California, United States, 91324
        • Northridge Kidney Care Center
      • Pico Rivera, California, United States, 90660
        • Integrity Medical Discovery
      • Pomona, California, United States, 91768
        • National Institute of Clinical Research
      • Riverside, California, United States, 92505
        • Nephrology Associates Medical Group
      • Sacramento, California, United States, 95817
        • UC Davis Medical Group GI Unit
      • San Dimas, California, United States, 91773
        • North America Research Institute
      • Valencia, California, United States, 91355
        • Henry Mayo Newhall Hospital
    • Delaware
      • Newark, Delaware, United States, 19713
        • Nephrology Associates PA
    • Florida
      • Coral Springs, Florida, United States, 33313
        • West Broward Research Institute
      • Fort Lauderdale, Florida, United States, 33316
        • Florida Kidney Physicians
      • Fort Lauderdale, Florida, United States, 33316
        • South Fort Lauderdale Nephrology
      • Gainesville, Florida, United States, 32608
        • University of Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Loxahatchee Groves, Florida, United States, 33470
        • Ethos Palm Beach
      • Miami, Florida, United States, 33155
        • Global Clinix, LLC
      • Miami, Florida, United States, 33172
        • Professional Research Center, Inc.
      • Miami Beach, Florida, United States, 33140
        • New Phase Clinical Trials
      • Sanford, Florida, United States, 32771
        • Infigo Clinical Research
      • Tampa, Florida, United States, 33603
        • Genesis Clinical Research
    • Georgia
      • Acworth, Georgia, United States, 30101
        • American Clinical Trials
      • Augusta, Georgia, United States, 30912
        • Wellstar Health System
    • Idaho
      • Boise, Idaho, United States, 83706
        • Boise Kidney and Hypertension PLLC
      • Chubbuck, Idaho, United States, 83202
        • CARE Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center
      • Chicago, Illinois, United States, 60616
        • Insight Hospital & Medical Center Chicago
    • Indiana
      • Fishers, Indiana, United States, 46037
        • Indiana Nephrology
      • Mishawaka, Indiana, United States, 46545
        • Fresenius Kidney Care Mishawaka
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Nephrology Associates of Lexington
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Sciences Center
    • Maryland
      • Takoma Park, Maryland, United States, 20854
        • Washington Nephrology Associates
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Holyoke Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Kalamazoo, Michigan, United States, 49007
        • Nephrology Center, PC
      • Roseville, Michigan, United States, 48066
        • St. Clair Nephrology Research
    • Mississippi
      • Brookhaven, Mississippi, United States, 39601
        • Southwest MS Nephrology
      • Columbus, Mississippi, United States, 39705
        • Nephrology Associates
      • Tupelo, Mississippi, United States, 38801
        • Nephrology and Hypertension Associates
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Seacoast Kidney & Hypertension Specialists
    • New York
      • New York, New York, United States, 10029
        • Icahn School Of Medicine At Mount Sinai
      • New York, New York, United States, 10017
        • NYU Langone
      • The Bronx, New York, United States, 10461
        • Jacobi Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Chapel Hill
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • Lifespan Clinical Research Center
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Dunes Clinical Research
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Knoxville Kidney Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Cypress, Texas, United States, 77429
        • Pioneer Research Solutions, Inc.
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health
      • El Paso, Texas, United States, 79905
        • Texas Tech Health Sciences
      • Houston, Texas, United States, 77091
        • United Memorial Medical Center
      • Houston, Texas, United States, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77054
        • Prolato Clinical Research Center
      • Houston, Texas, United States, 77004
        • Plaza Nephrology
      • Houston, Texas, United States, 77090
        • Clinical Research Strategies, Inc
      • San Antonio, Texas, United States, 78212
        • Clinical Advancement Center, PLLC
      • San Antonio, Texas, United States, 78229
        • University Health System
      • Sugar Land, Texas, United States, 77479
        • Prolato Clinical Research Center - Sugar Land
      • The Woodlands, Texas, United States, 77384
        • Renal Physicians of Montgomery County
    • Virginia
      • Salem, Virginia, United States, 24153
        • Salem VA Medical Center
    • Washington
      • Spokane, Washington, United States, 99204
        • Providence Medical Research Ctr
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin-Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Sham Procedure
Participants randomized to the Sham Comparator arm will have 2 sham procedures.
Procedure: Sham 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.
Experimental: Experimental (REACT/rilparencel injections)
Participants randomized to the experimental arm will receive 2 injections of REACT/ rilparencel.
Biological: Renal 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surrogate / Intermediate Efficacy Endpoint -eGFR Slope
Time Frame: 18 months after the 135th participant receives their first injection / sham.
The difference in annualized eGFR slope between the rilparencel and sham cohorts (approximately 18 months after the 135th participant receives their first injection/sham) using the 2021 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) serum creatinine-based equation.
18 months after the 135th participant receives their first injection / sham.
Clinical Endpoint
Time Frame: From date of first injection until the date of first event: 40% reduction in eGFR, eGFR < 15 mL/min/1.73m² and/or chronic dialysis, and or renal transplant or date of renal or cardiovascular death, whichever came first, assessed up to 94 months.

The time from first injection to the earliest of:

  • At least 40% reduction in eGFR, sustained for 30 days, OR
  • eGFR <15 mL/min/1.73m² with corresponding two-sided 95% CI, sustained for 30 days and/or chronic dialysis, and/or kidney transplant OR
  • Renal or cardiovascular death
From date of first injection until the date of first event: 40% reduction in eGFR, eGFR < 15 mL/min/1.73m² and/or chronic dialysis, and or renal transplant or date of renal or cardiovascular death, whichever came first, assessed up to 94 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Endpoint: Time from first injection to at least a 40% reduction in eGFR sustained for 30 days.
Time Frame: From date of first injection until the date of 40% reduction in eGFR assessed up to 94 months.
• Time from first injection to at least a 40% reduction in eGFR sustained for 30 days.
From date of first injection until the date of 40% reduction in eGFR assessed up to 94 months.
Secondary Endpoint: Time from first injection to eGFR < 15 mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or kidney transplant.
Time Frame: From date of first injection until the date of eGFR < 15 mL/min/1.73m² assessed up to 94 months.
• Time from first injection to eGFR < 15 mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or kidney transplant.
From date of first injection until the date of eGFR < 15 mL/min/1.73m² assessed up to 94 months.
Secondary Endpoint: All-cause mortality.
Time Frame: From date of first injection to all-cause mortality assessed up to 94 months.
The time from first injection to all-cause mortality.
From date of first injection to all-cause mortality assessed up to 94 months.
Secondary Endpoint: Kidney Disease Quality of Life Changes
Time Frame: Week 52

• Changes from Baseline in patient-reported outcome from the Burden of Kidney Disease domain at Week 52 from the Kidney Disease Quality of Life (KDQOL) Questionnaire.

The survey is used to assess the burden, symptoms/problems, and effects of kidney disease on a patient's quality of life.
Week 52
Secondary Endpoint: Quality of Life
Time Frame: Week 52

Changes from Baseline in patient-reported outcome EuroQol 5-Dimension 5-Level (EQ5D-5L) at Week 52.

The descriptive system is divided into 5 levels of perceived problems with level 1 (indicating no problem) and level 5 (indicating extreme problems).
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prokidney

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PPD
IQVIA Pty Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Prokidney

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REGEN-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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