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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Procedure | Sham Comparator | Participants randomized to the Sham Comparator arm will have 2 sham procedures. |
|
| Experimental (REACT/rilparencel injections) | Experimental | Participants randomized to the experimental arm will receive 2 injections of REACT/ rilparencel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months after the 135th participant receives their first injection / sham. |
| Clinical Endpoint | The time from first injection to the earliest of:
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ProKidney Call Center | Contact | (866)955 4394 | proact1@careboxhealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Prokidney | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrology Consultants | Recruiting | Huntsville | Alabama | 35805 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41481370 | Derived | 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. | |
| 40333016 | Derived |
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|
| Sham Comparator | Procedure | 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. |
|
• 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. | 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 | • 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 | 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 |
| University of Arizona | Recruiting | Tucson | Arizona | 85724 | United States |
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| Amicis Research Center | Active, not recruiting | Beverly Hills | California | 90211 | United States |
| Paradise Clinical Research Group LLC | Withdrawn | Glendora | California | 91741 | United States |
| Kidney Consultants Medical Group | Active, not recruiting | Granada Hills | California | 91344 | United States |
| IMD Clinical Trials | Recruiting | Huntington Park | California | 90255 | United States |
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| Advanced Medical Research, LLC | Recruiting | Lakewood | California | 90712 | United States |
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| Medicine and Nephrology Associates | Recruiting | Los Alamitos | California | 90720 | United States |
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| Academic Medical Research Institute | Recruiting | Los Angeles | California | 90022 | United States |
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| Southern California Hospital | Recruiting | Los Angeles | California | 90095 | United States |
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| Allameh Medical Corporation | Completed | Mission Viejo | California | 92691 | United States |
| Golden Pacific Nephrology Medical Clinic Inc | Recruiting | Monterey Park | California | 91755 | United States |
|
| Northridge Kidney Care Center | Active, not recruiting | Northridge | California | 91324 | United States |
| Valley Renal Medical Group | Recruiting | Northridge | California | 91324 | United States |
|
| Valley Clinical Trials | Recruiting | Northridge | California | 91325 | United States |
|
| Integrity Medical Discovery | Active, not recruiting | Pico Rivera | California | 90660 | United States |
| National Institute of Clinical Research | Recruiting | Pomona | California | 91768 | United States |
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| Nephrology Associates Medical Group | Recruiting | Riverside | California | 92505 | United States |
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| UC Davis Medical Group GI Unit | Recruiting | Sacramento | California | 95817 | United States |
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| North America Research Institute | Recruiting | San Dimas | California | 91773 | United States |
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| Henry Mayo Newhall Hospital | Active, not recruiting | Valencia | California | 91355 | United States |
| Nephrology Associates PA | Recruiting | Newark | Delaware | 19713 | United States |
|
| West Broward Research Institute | Active, not recruiting | Coral Springs | Florida | 33313 | United States |
| Florida Kidney Physicians | Completed | Fort Lauderdale | Florida | 33316 | United States |
| South Fort Lauderdale Nephrology | Recruiting | Fort Lauderdale | Florida | 33316 | United States |
|
| University of Florida | Recruiting | Gainesville | Florida | 32608 | United States |
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| Mayo Clinic | Recruiting | Jacksonville | Florida | 32224 | United States |
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| Ethos Palm Beach | Recruiting | Loxahatchee Groves | Florida | 33470 | United States |
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| Global Clinix, LLC | Recruiting | Miami | Florida | 33155 | United States |
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| Professional Research Center, Inc. | Recruiting | Miami | Florida | 33172 | United States |
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| New Phase Clinical Trials | Recruiting | Miami Beach | Florida | 33140 | United States |
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| Infigo Clinical Research | Recruiting | Sanford | Florida | 32771 | United States |
|
| Genesis Clinical Research | Completed | Tampa | Florida | 33603 | United States |
| American Clinical Trials | Terminated | Acworth | Georgia | 30101 | United States |
| Wellstar Health System | Recruiting | Augusta | Georgia | 30912 | United States |
|
| Boise Kidney and Hypertension PLLC | Recruiting | Boise | Idaho | 83706 | United States |
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| Care Institute | Recruiting | Chubbuck | Idaho | 83202 | United States |
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| Insight Hospital & Medical Center Chicago | Recruiting | Chicago | Illinois | 60616 | United States |
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| The University of Chicago Medical Center | Active, not recruiting | Chicago | Illinois | 60637 | United States |
| Indiana Nephrology | Recruiting | Fishers | Indiana | 46037 | United States |
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| Fresenius Kidney Care Mishawaka | Recruiting | Mishawaka | Indiana | 46545 | United States |
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| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| Nephrology Associates of Lexington | Recruiting | Lexington | Kentucky | 40504 | United States |
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| LSU Health Sciences Center | Recruiting | Shreveport | Louisiana | 71103 | United States |
|
| Washington Nephrology Associates | Completed | Takoma Park | Maryland | 20854 | United States |
| Holyoke Medical Center | Suspended | Springfield | Massachusetts | 01107 | United States |
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Nephrology Center, PC | Recruiting | Kalamazoo | Michigan | 49007 | United States |
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| St. Clair Nephrology Research | Suspended | Roseville | Michigan | 48066 | United States |
| Southwest MS Nephrology | Recruiting | Brookhaven | Mississippi | 39601 | United States |
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| Nephrology Associates | Recruiting | Columbus | Mississippi | 39705 | United States |
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| Nephrology and Hypertension Associates | Recruiting | Tupelo | Mississippi | 38801 | United States |
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| Saint Louis University | Withdrawn | St Louis | Missouri | 63110 | United States |
| Nevada Kidney Disease & Hypertension Center | Withdrawn | Las Vegas | Nevada | 89052 | United States |
| Seacoast Kidney & Hypertension Specialists | Recruiting | Portsmouth | New Hampshire | 03801 | United States |
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| NYU Langone | Recruiting | New York | New York | 10017 | United States |
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| ICAHN School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| Jacobi Medical Center | Recruiting | The Bronx | New York | 10461 | United States |
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| UNC Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| Lifespan Clinical Research Center | Recruiting | East Providence | Rhode Island | 02915 | United States |
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| Rhode Island Hospital | Withdrawn | Providence | Rhode Island | 02903 | United States |
| Dunes Clinical Research | Recruiting | Dakota Dunes | South Dakota | 57049 | United States |
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| Knoxville Kidney Center | Recruiting | Knoxville | Tennessee | 37923 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Pioneer Research Solutions, Inc. | Recruiting | Cypress | Texas | 77429 | United States |
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| Texas Tech Health Sciences | Completed | El Paso | Texas | 79905 | United States |
| Texas Tech University Health | Active, not recruiting | El Paso | Texas | 79905 | United States |
| Plaza Nephrology | Recruiting | Houston | Texas | 77004 | United States |
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| Biopharma Informatic, LLC | Suspended | Houston | Texas | 77043 | United States |
| Prolato Clinical Research Center | Recruiting | Houston | Texas | 77054 | United States |
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| Clinical Research Strategies, Inc | Recruiting | Houston | Texas | 77090 | United States |
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| United Memorial Medical Center | Recruiting | Houston | Texas | 77091 | United States |
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| Clinical Advancement Center, PLLC | Recruiting | San Antonio | Texas | 78212 | United States |
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| University Health System | Recruiting | San Antonio | Texas | 78229 | United States |
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| Prolato Clinical Research Center - Sugar Land | Recruiting | Sugar Land | Texas | 77479 | United States |
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| Renal Physicians of Montgomery County | Recruiting | The Woodlands | Texas | 77384 | United States |
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| Salem VA Medical Center | Recruiting | Salem | Virginia | 24153 | United States |
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| Providence Medical Research Ctr | Recruiting | Spokane | Washington | 99204 | United States |
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| University of Wisconsin-Madison | Recruiting | Madison | Wisconsin | 53792 | United States |
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| St. George Hospital | Withdrawn | Kogarah | New South Wales | 2217 | Australia |
| Lakeridge Health Corporation-Oshawa | Withdrawn | Oshawa | Ontario | Canada |
| "Ignacio Chavez" National Cardiology Institute | Recruiting | Tlalpan | Mexico City | 14080 | Mexico |
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| National Institute of Medical Sciences and Nutrition Salvador Zubiran | Recruiting | Tlalpan | Mexico City | 14080 | Mexico |
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| Torre Medica San Lucas | Recruiting | Ponce | 00716 | Puerto Rico |
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| San Miguel Medical | Recruiting | Trujillo Alto | 00976 | Puerto Rico |
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| Far Eastern Memorial Hospital | Suspended | New Taipei City | 220 | Taiwan |
| Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare | Recruiting | New Taipei City | 23561 | Taiwan |
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| China Medical University Hospital | Active, not recruiting | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Recruiting | Taichung | Taiwan |
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| National Taiwan University Hospital | Recruiting | Taipei | 100225 | Taiwan |
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| Taipei Medical University Hospital | Recruiting | Taipei | 110 | Taiwan |
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| Tri-Service General Hospital | Recruiting | Taipei | 11490 | Taiwan |
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| Taipei Municipal Wanfang Hospital Managed by Taipei Medical University | Active, not recruiting | Taipei | 116 | Taiwan |
| Taipei Municipal Wanfang Hospital | Recruiting | Taipei | Taiwan |
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| Royal London Hospital | Withdrawn | London | E1 1FR | United Kingdom |
| 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. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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