Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
NCT ID: NCT05099770
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
685 participants
INTERVENTIONAL
2022-01-05
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sham Procedure
Participants randomized to the Sham Comparator arm will have 2 sham procedures.
Sham Comparator
Participants will have 2 sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The second sham procedure will occur 12 weeks (+28 days) after the first sham procedure.
Experimental (REACT/rilparencel injections)
Participants randomized to the experimental arm will receive 2 injections of REACT/ rilparencel.
Renal Autologous Cell Therapy (REACT)
Participants will have a kidney biopsy followed 14 weeks later with a REACT injection into the biopsied kidney, then, another 12 weeks (+28 days) later a REACT injection into their contralateral kidney.
Interventions
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Renal Autologous Cell Therapy (REACT)
Participants will have a kidney biopsy followed 14 weeks later with a REACT injection into the biopsied kidney, then, another 12 weeks (+28 days) later a REACT injection into their contralateral kidney.
Sham Comparator
Participants will have 2 sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The second sham procedure will occur 12 weeks (+28 days) after the first sham procedure.
Eligibility Criteria
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Inclusion Criteria
2. Documented diagnosis of type 2 diabetes mellitus (T2DM) and chronic kidney disease as the underlying cause of kidney disease (diagnosis does not have to be confirmed by kidney biopsy).
1. eGFR of at least 20 mL/min/1.73 m2 AND \<30 mL/min/1.73 m2, not requiring kidney dialysis. UACR level cannot exceed 5000 mg/g (565 mg/mmol), OR
2. eGFR of 30 to ≤ 35 mL/min/1.73m2 AND UACR of 300 to ≤ 5000 mg/g (33.9 mg/mmol to ≤565 mg/mmol).
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, based on average of 3 consecutive measurements obtained seated or supine. Note: Retesting may be performed if initial screening blood pressure exceeds eligibility criteria for systolic and/or diastolic blood pressure. Changes in blood pressure Page 46 of 113 CONFIDENTIAL ProKidney Renal Autologous Cell Therapy Clinical Protocol REGEN-006 USAN/INN: Rilparencel Version 6.0 medications will be recorded in the appropriate eCRF. (refer to BP procedures)
5. All participants should be strongly considered for treatment with sodium-glucose cotransporter 2 inhibitor (SGLT2i). For participants on SGLT2i medications, the dose must be stable for at least 4 weeks prior to randomization. Note: The reason for a participant NOT receiving SGLT2i therapy at the time of randomization will be documented in the eCRF. (See Section 7.1 for additional guidance about Concomitant Therapies).
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. The dose must be stable for at least 4 weeks prior to randomization. Note: The reason for a participant NOT receiving an ACEI or ARB at the time of randomization will be documented in the eCRF. (See Section 7.1 for additional guidance about Concomitant Therapies).
7. Participant agrees, and in the judgement of the Investigator, is able to refrain from using therapies that may increase bleeding risk for the specified pre-procedure and postprocedure (biopsy/sham biopsy and rilparencel/sham injections) durations in the discretion of the PI in consultation with the treating physician, in accordance with the required minimum medication-specific guidelines for high-risk procedures59 and patients with advanced CKD.
* Nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen and naproxen
* Aspirin
* Platelet aggregation inhibitors (PAIs) such as clopidogrel, prasugrel, and dipyridamole
* Factor Xa inhibitors
* Warfarin
* Heparin products
* Other anticoagulation.
8. Participant is willing and able to cooperate with all aspects of the protocol.
9. Participant is willing and able to provide signed informed consent.
Exclusion Criteria
2. The participant has a history of renal transplantation or other organ transplantation (corneal transplants are not an exclusion), solitary kidney, recurrent complicated urinary tract infections or complicated kidney stones. Urinary tract infections identified prior to renal biopsy or injection should be resolved prior to procedures.
3. The participant has any other known underlying cause of kidney disease, including but not limited to: Autosomal dominant and recessive polycystic kidney disease, primary focal segmental glomerulosclerosis, vasculitis related CKD, IgA nephropathy and other immune modulated nephropathies, drug-induced CKD or other types of CKD or anatomic variants as determined by the Investigator or Sponsor that would interfere with biopsy and rilparencel injection procedure or confound study assessments.
Note: The following are not considered exclusionary under the following conditions: (Unique situations should be discussed with the study Medical Monitor.)
* Concomitant hypertension-related CKD
* Anatomic abnormalities and benign conditions are not exclusionary if the kidney has accessible kidney cortex for biopsy and injection procedures and meets the criteria to receive the rilparencel injection.
* Abnormalities on kidney biopsy (e.g., secondary focal segmental glomerulosclerosis) which are considered secondary to diabetes with the following conditions: lack of other identifiable etiology, full evaluation for other etiologies, no specific treatment administered other than diabetes management.
4. History of acute kidney injury or major surgery (based on the judgement of the Investigator and Medical Monitor) within 3 months prior to the Screening Visit.
5. Myocardial infarction, unstable angina, revascularization procedure (e.g. stent or bypass graft surgery), 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 malignancy within the past 3 years prior to Screening, except for basal cell and/or squamous cell carcinomas of the skin with apparent successful curative therapy, carcinoma of the cervix in situ, or a malignancy that in the opinion of the Investigator, along with agreement from the Medical Monitor, is considered treated with no evidence of disease and at minimal risk of recurrence.
8. Documented clinically significant liver disease, including acute or chronic hepatitis B or hepatitis C. Note: At the discretion of the Investigator, a participant who gives a history of a treated and cured Hepatitis C infection may be screened with a test for viral ribonucleic acid (RNA), and if a cure is demonstrated, the participant may be enrolled.
9. Known infection with HIV, active syphilis, or other unresolved active genitourinary infection, or active tuberculosis requiring treatment at Screening.
30 Years
80 Years
ALL
No
Sponsors
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Prokidney
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Prokidney
Locations
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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
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
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
University of Iowa
Iowa City, Iowa, 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
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
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
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
Countries
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Central Contacts
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Facility Contacts
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Bijin Thajudeen, MD
Role: primary
Victor Carabello, MD
Role: primary
Adarsh Daswani, MD
Role: primary
Victor Kabbany, MD
Role: primary
Mohamed El-Shahawy, MD
Role: primary
Anjay Rastogi, MD
Role: primary
Paul Hwu, MD
Role: primary
Sohan Dua, MD
Role: primary
Christopher Chow, MD
Role: primary
Dalia Dawoud, MD
Role: primary
Prasanth Surampudi, MD
Role: primary
Morgan Balaban
Role: backup
Aamir Jamal, MD
Role: primary
Theodore Saad, MD
Role: primary
Zachary Yablon, MD
Role: primary
Mark Segal, MD
Role: primary
LaTonya Hickson, MD
Role: primary
Sayed Ali, MD
Role: primary
Jeffrey Maldonado, MD
Role: primary
Jorge Posada, MD
Role: primary
Letica Adan, MD
Role: primary
Sayed Husain, MD
Role: primary
Arnold Silva, MD
Role: primary
Hira Siktel, MD
Role: primary
Rizwan Moinuddin, MD
Role: primary
Ravneet Dhillon, MD
Role: primary
Mony Fraer, MD
Role: primary
Bharat Sachdeva, MD
Role: primary
Karthik Ramani, MD
Role: primary
Ahmed Aqeel, MD
Role: primary
Thomas Wooldridge, MD
Role: primary
Sucharit Joshi, MD
Role: primary
Steven Coca, MD
Role: primary
Anjali Acharya, MD
Role: primary
Randy Detwiler, MD
Role: primary
George Bayliss, MD
Role: primary
Ashar Luqman, MD
Role: primary
Kendra Hendon, MD
Role: primary
Anna Burgner, MD
Role: primary
Rahul Pandey, MD
Role: primary
Justin Merszei, MD
Role: primary
Sreedhar Mandayam, MD
Role: primary
Christopher Kwoh, MD
Role: primary
Wasae Tabibi, MD
Role: primary
Pablo Pergola, MD
Role: primary
Shweta Bansal, MD
Role: primary
Biruh Workeneh, MD
Role: primary
Harini Bejjanki, MD
Role: primary
Devasmita Dev, MD
Role: primary
Radica Alicic, MD
Role: primary
Ali Gardezi, MD
Role: primary
Magdalena Madero, MD
Role: primary
Luis Morales, MD
Role: primary
Felix Perez Ramos, MD
Role: primary
Elba Perez-Vargas, MD
Role: primary
Mai-Szu Wu, MD
Role: primary
Ming-Ju Wu, MD
Role: primary
Chin-Chin Kao, MD
Role: primary
Yu-Juei Hsu, MD
Role: primary
Chung-Yi Cheng, MD
Role: primary
References
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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.
Other Identifiers
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REGEN-006
Identifier Type: -
Identifier Source: org_study_id
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