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Type 2 Diabetes MellitusPhase 3NCT05099770

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

A Phase 3 study testing Renal Autologous Cell Therapy (REACT/ rilparencel) in people with Type 2 Diabetes Mellitus and Chronic Kidney Diseases, run by Prokidney at 88 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 years
What is being tested?
Renal Autologous Cell Therapy (REACT/ rilparencel)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
685 participants
Where
88 sitesin 4 countries
Study dates
5 Jan 2022to Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant is male or female, 30 to 80 years of age on the date of informed consent.
  • Documented diagnosis of type 2 diabetes mellitus (T2DM) and chronic kidney disease
  • Serum glycosylated hemoglobin (HbA1c) of 9.5% or lower at Screening.
  • Systolic blood pressure of ≤ 140 mm Hg and diastolic blood pressure of ≤ 90 mm Hg at Screening.
  • All 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.
  • Participant agrees and is able to refrain from using therapies that may increase bleeding risk for the specified pre-procedure and post-procedure durations.
  • Participant is willing and able to cooperate with all aspects of the protocol and provide signed informed consent.

Who cannot join

  • The participant has a history of type 1 diabetes mellitus.
  • The participant has a history of renal transplantation or other organ transplantation
  • The participant has any other known underlying cause of kidney disease
  • History of acute kidney injury or major surgery within 3 months prior to the Screening Visit.
  • Myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before randomization, or a revascularization procedure is planned during the trial.
  • Current or history of heart failure of New York Heart Association (NYHA) Class IV cardiac disease.
Show all 17Show fewer
  • History of exclusionary malignancy within the past 3 years prior to Screening
  • Documented clinically significant liver disease, including acute or chronic hepatitis B or hepatitis C.
  • Known infection with HIV, active syphilis, or other unresolved active genitourinary infection, or active tuberculosis requiring treatment at Screening.
  • Immunocompromised condition or condition requiring chronic immunosuppressive agents, including individuals treated for chronic glomerulonephritis, within 3 months of signing ICF.
  • Has had a recent bleeding event or a known bleeding disorder(s) or increased risk of either thromboembolism or bleeding.
  • Kidney imaging reveals contraindications for undergoing biopsy or rilparencel injection
  • Maintained on any anticoagulant agents
  • 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.
  • History of severe systemic reaction(s) or any contraindication to local anesthetics or sedatives.
  • Use of an investigational product or device within 12 weeks prior to Randomization or previous treatment with rilparencel.
  • Participant's health status would, in the judgement of the Investigator, be jeopardized by participating in the study.

Trial locations and contacts

88 sites in 4 countries.

88 sites in 4 countries

United States75 sites

  • American Clinical Trials

    Acworth, Georgia, 30101

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Wellstar Health System

    Augusta, Georgia, 30912

  • Amicis Research Center

    Beverly Hills, California, 90211

  • Boise Kidney and Hypertension PLLC

    Boise, Idaho, 83706

  • Southwest MS Nephrology

    Brookhaven, Mississippi, 39601

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Insight Hospital & Medical Center Chicago

    Chicago, Illinois, 60616

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Care Institute

    Chubbuck, Idaho, 83202

  • Nephrology Associates

    Columbus, Mississippi, 39705

  • West Broward Research Institute

    Coral Springs, Florida, 33313

  • Pioneer Research Solutions, Inc.

    Cypress, Texas, 77429

  • Dunes Clinical Research

    Dakota Dunes, South Dakota, 57049

  • Lifespan Clinical Research Center

    East Providence, Rhode Island, 02915

  • Texas Tech Health Sciences

    El Paso, Texas, 79905

  • Texas Tech University Health

    El Paso, Texas, 79905

  • Indiana Nephrology

    Fishers, Indiana, 46037

  • Florida Kidney Physicians

    Fort Lauderdale, Florida, 33316

  • South Fort Lauderdale Nephrology

    Fort Lauderdale, Florida, 33316

  • University of Florida

    Gainesville, Florida, 32608

  • Kidney Consultants Medical Group

    Granada Hills, California, 91344

  • Plaza Nephrology

    Houston, Texas, 77004

  • Biopharma Informatic, LLC

    Houston, Texas, 77043

  • Prolato Clinical Research Center

    Houston, Texas, 77054

  • Clinical Research Strategies, Inc

    Houston, Texas, 77090

  • United Memorial Medical Center

    Houston, Texas, 77091

  • IMD Clinical Trials

    Huntington Park, California, 90255

  • Nephrology Consultants

    Huntsville, Alabama, 35805

  • University of Iowa

    Iowa City, Iowa, 52242

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Nephrology Center, PC

    Kalamazoo, Michigan, 49007

  • Knoxville Kidney Center

    Knoxville, Tennessee, 37923

  • Advanced Medical Research, LLC

    Lakewood, California, 90712

  • Nephrology Associates of Lexington

    Lexington, Kentucky, 40504

  • Medicine and Nephrology Associates

    Los Alamitos, California, 90720

  • Academic Medical Research Institute

    Los Angeles, California, 90022

  • Southern California Hospital

    Los Angeles, California, 90095

  • Ethos Palm Beach

    Loxahatchee Groves, Florida, 33470

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792

  • Global Clinix, LLC

    Miami, Florida, 33155

  • Professional Research Center, Inc.

    Miami, Florida, 33172

  • New Phase Clinical Trials

    Miami Beach, Florida, 33140

  • Fresenius Kidney Care Mishawaka

    Mishawaka, Indiana, 46545

  • Allameh Medical Corporation

    Mission Viejo, California, 92691

  • Golden Pacific Nephrology Medical Clinic Inc

    Monterey Park, California, 91755

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • NYU Langone

    New York, New York, 10017

  • ICAHN School of Medicine at Mount Sinai

    New York, New York, 10029

  • Nephrology Associates PA

    Newark, Delaware, 19713

  • Northridge Kidney Care Center

    Northridge, California, 91324

  • Valley Renal Medical Group

    Northridge, California, 91324

  • Valley Clinical Trials

    Northridge, California, 91325

  • Integrity Medical Discovery

    Pico Rivera, California, 90660

  • National Institute of Clinical Research

    Pomona, California, 91768

  • Seacoast Kidney & Hypertension Specialists

    Portsmouth, New Hampshire, 03801

  • Nephrology Associates Medical Group

    Riverside, California, 92505

  • St. Clair Nephrology Research

    Roseville, Michigan, 48066

  • UC Davis Medical Group GI Unit

    Sacramento, California, 95817

  • Salem VA Medical Center

    Salem, Virginia, 24153

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212

  • University Health System

    San Antonio, Texas, 78229

  • North America Research Institute

    San Dimas, California, 91773

  • Infigo Clinical Research

    Sanford, Florida, 32771

  • LSU Health Sciences Center

    Shreveport, Louisiana, 71103

  • Providence Medical Research Ctr

    Spokane, Washington, 99204

  • Holyoke Medical Center

    Springfield, Massachusetts, 01107

  • Prolato Clinical Research Center - Sugar Land

    Sugar Land, Texas, 77479

  • Washington Nephrology Associates

    Takoma Park, Maryland, 20854

  • Genesis Clinical Research

    Tampa, Florida, 33603

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • Renal Physicians of Montgomery County

    The Woodlands, Texas, 77384

  • University of Arizona

    Tucson, Arizona, 85724

  • Nephrology and Hypertension Associates

    Tupelo, Mississippi, 38801

  • Henry Mayo Newhall Hospital

    Valencia, California, 91355

Other trials in United States

Taiwan9 sites

  • Far Eastern Memorial Hospital

    New Taipei City, 220

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

    New Taipei City, 23561

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung

  • National Taiwan University Hospital

    Taipei, 100225

  • Taipei Medical University Hospital

    Taipei, 110

  • Tri-Service General Hospital

    Taipei, 11490

  • Taipei Municipal Wanfang Hospital Managed by Taipei Medical University

    Taipei, 116

  • Taipei Municipal Wanfang Hospital

    Taipei

Other trials in Taiwan

Mexico2 sites

  • "Ignacio Chavez" National Cardiology Institute

    Tlalpan, Mexico City, 14080

  • National Institute of Medical Sciences and Nutrition Salvador Zubiran

    Tlalpan, Mexico City, 14080

Other trials in Mexico

Puerto Rico2 sites

  • Torre Medica San Lucas

    Ponce, 00716

  • San Miguel Medical

    Trujillo Alto, 00976

Other trials in Puerto Rico

About this study

Official title: 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.

Read the 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.

Being tested
Renal Autologous Cell Therapy (REACT/ rilparencel), Sham Comparator
Keywords
REACT®, Type 2 Diabetes Mellitus, Rilparencel, Proact
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Renal Autologous Cell Therapy (REACT/ rilparencel)Biological

    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.

  • Sham ComparatorProcedure or surgery

    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.

Study groups in NCT05099770
Study groupRoleWhat they receive
Sham ProcedureSham comparatorParticipants randomized to the Sham Comparator arm will have 2 sham procedures.
Receives: Procedure: Sham Comparator
Experimental (REACT/rilparencel injections)ExperimentalParticipants randomized to the experimental arm will receive 2 injections of REACT/ rilparencel.
Receives: Biological: Renal Autologous Cell Therapy (REACT/ rilparencel)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surrogate / Intermediate Efficacy Endpoint -eGFR Slope

    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.

    Measured: 18 months after the 135th participant receives their first injection / sham.

  2. Clinical Endpoint

    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

    Measured: 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 outcomes (5)

  1. Secondary Endpoint: Time from first injection to at least a 40% reduction in eGFR sustained for 30 days.

    • Time from first injection to at least a 40% reduction in eGFR sustained for 30 days.

    Measured: From date of first injection until the date of 40% reduction in eGFR assessed up to 94 months.

  2. 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 from first injection to eGFR < 15 mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or kidney transplant.

    Measured: From date of first injection until the date of eGFR < 15 mL/min/1.73m² assessed up to 94 months.

  3. Secondary Endpoint: All-cause mortality.

    The time from first injection to all-cause mortality.

    Measured: From date of first injection to all-cause mortality assessed up to 94 months.

  4. Secondary Endpoint: Kidney Disease Quality of Life Changes

    • 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.

    Measured: Week 52

  5. Secondary Endpoint: Quality of Life

    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).

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2021
  2. Study start5 Jan 2022
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
685 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05099770
Sponsor's protocol ID
REGEN-006
Status last verified
Aug 2026
First submitted
18 Oct 2021
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cizman B, Butler EL, Stavas J, Prakash R, Saad T, Silva A, Wooldridge T, Aqeel A, Yan H, Barysauskas CM, Culleton B. A Randomized Clinical Trial of Kidney Autologous Cell Therapy in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Jan 2;21(5):744-53. doi: 10.2215/CJN.0000000969. Online ahead of print.

    PubMed 41481370

  • Patel HA, Wang J, Zinn CJ, Learmonth M, Lerman LO, Wolfram J, Hickson LJ. Fortifying the Diabetic Kidney Disease Treatment Armamentarium: Multitarget Senotherapeutic and Regenerative Strategies. J Am Soc Nephrol. 2025 May 7;36(8):1655-1658. doi: 10.1681/ASN.0000000754. No abstract available.

    PubMed 40333016

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Renal Autologous Cell Therapy (REACT/ rilparencel) in people with Type 2 Diabetes Mellitus and Chronic Kidney Diseases, run by Prokidney at 88 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Taiwan, Mexico, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surrogate / Intermediate Efficacy Endpoint -eGFR Slope (time frame: 18 months after the 135th participant receives their first injection / sham.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05099770, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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