A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
- Conditions
- Type 2 Diabetes MellitusChronic Kidney Diseases
- Interventions
- Procedure: Sham ComparatorBiological: Renal Autologous Cell Therapy (REACT)
- Registration Number
- NCT05099770
- Lead Sponsor
- Prokidney
- Brief Summary
The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.
- 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 undergo sham procedures and be followed to the global trial end date. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed to the global trial end date. This event driven study is estimated to have a total maximum duration of 5 years.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 685
-
The participant is male or female, 30 to 80 years of age on the date of informed consent.
-
The participant has a clinical diagnosis of T2DM in their health record.
-
The participant has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy) in their health record.
-
The participant has a serum glycosylated hemoglobin (HbA1c) less than 9.5% at the Screening Visit.
-
The participant has a documented clinical diagnosis of either:
eGFR greater than or equal to 20 and less than 30 mL/min/1.73m², not requiring renal dialysis. UACR level cannot exceed 5000 mg/g (565 mg/mmol) OR: eGFR of 30 to less than or equal to 35 mL/min/1.73m² AND UACR of 300 to less than or equal to 5000mg/g (33.9 mg/mmol to less than or equal to 565 mg/mmol).
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Systolic blood pressure of ≤ 140 mm Hg and diastolic blood pressure of ≤ 90 mm Hg at Screening (based on the average of 3 measurements obtained while seated) and maintained during the screening period until randomization.
-
On a clinically relevant and stable dose of an angiotensin converting-enzyme inhibitor (ACEI) OR an angiotensin receptor blocker (ARB), unless not tolerated or contraindicated.
- The participant has a history of type 1 diabetes mellitus.
- 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.
- 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 REACT injection procedure or confound study assessments.
- History of acute kidney injury within 3 months prior to the Screening Visit.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Procedure Sham Comparator Participants randomized to the Sham Comparator arm will have 2 sham procedures. Experimental (REACT injections) Renal Autologous Cell Therapy (REACT) Participants randomized to the experimental arm will receive 2 injections of REACT.
- Primary Outcome Measures
Name Time Method Primary Composite Endpoint up to 60 Months The time from first injection to the earliest of:
* At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or
* eGFR \<15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant or Renal or cardiovascular death
- Secondary Outcome Measures
Name Time Method Secondary Composite Endpoint: Change in eGFR from first injection up to 60 Months • Time from first injection to at least a 40% reduction in eGFR sustained for 30 days.
Secondary Composite Endpoint: Mortality up to 60 Months The time from first injection to all-cause mortality.
Secondary Composite Endpoint: Quality of Life up to 60 Months • Changes from Baseline in patient-reported outcomes from the EuroQol 5-Dimension 5 Level (EQ-5D-5L) survey.
The descriptive system is divided into 5 levels of perceived problems with level 1 (indicating no problem) and level 5 (indicating extreme problems).Secondary Composite Endpoint: Change in eGFR up to 60 Months • Annualized change in eGFR
Secondary Composite Endpoint: Change in eGFR from first injection to End Stage Renal Disease (ESRD) up to 60 Months • Time from first injection to eGFR \< 15 mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or renal transplant.
Secondary Composite Endpoint: Quality of Life Changes up to 60 Months • Changes from Baseline in patient-reported outcome from the Kidney Disease Quality of Life (KDQOL) survey.
The survey is used to assess the burden, symptoms/problems, and effects of kidney disease on a patient's quality of life.
Trial Locations
- Locations (66)
Paradise Clinical Research Group LLC
🇺🇸Glendora, California, United States
Medicine and Nephrology Associates
🇺🇸Los Alamitos, California, United States
Academic Medical Research Institute
🇺🇸Los Angeles, California, United States
Valley Renal Medical Group
🇺🇸Northridge, California, United States
Henry Mayo Newhall Hospital
🇺🇸Valencia, California, United States
University of Florida
🇺🇸Gainesville, Florida, 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
Allameh Medical Corporation
🇺🇸Mission Viejo, California, United States
Northridge Kidney Care Center
🇺🇸Northridge, California, United States
Valley Clinical Trials
🇺🇸Northridge, California, United States
Integrity Medical Discovery
🇺🇸Pico Rivera, California, United States
UC Davis Medical Group GI Unit
🇺🇸Sacramento, California, United States
New Phase Clinical Trials
🇺🇸Miami Beach, Florida, United States
Golden Pacific Nephrology Medical Clinic Inc
🇺🇸Monterey Park, California, United States
North America Research Institute
🇺🇸San Dimas, 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
American Clinical Trials
🇺🇸Acworth, Georgia, United States
Insight Hospital & Medical Center Chicago
🇺🇸Chicago, Illinois, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Infigo Clinical Research
🇺🇸Sanford, Florida, United States
Genesis Clinical Research
🇺🇸Tampa, Florida, United States
Boise Kidney and Hypertension PLLC
🇺🇸Boise, Idaho, United States
Care Institute
🇺🇸Chubbuck, Idaho, United States
Indiana Nephrology
🇺🇸Fishers, Indiana, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Washington Nephrology Associates
🇺🇸Takoma Park, Maryland, United States
Holyoke Medical Center
🇺🇸Springfield, Massachusetts, United States
Nephrology and Hypertension Associates
🇺🇸Tupelo, Mississippi, United States
Knoxville Kidney Center
🇺🇸Knoxville, Tennessee, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
St. Clair Nephrology Research
🇺🇸Roseville, Michigan, United States
Nevada Kidney Disease & Hypertension Center
🇺🇸Las Vegas, Nevada, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Texas Tech Health Sciences
🇺🇸El Paso, Texas, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Seacoast Kidney & Hypertension Specialists
🇺🇸Portsmouth, New Hampshire, United States
UNC Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Dunes Clinical Research
🇺🇸Dakota Dunes, South Dakota, United States
Prolato Clinical Research Center
🇺🇸Houston, Texas, United States
United Memorial Medical Center
🇺🇸Houston, Texas, United States
Lifespan Clinical Research Center
🇺🇸East Providence, Rhode Island, United States
Pioneer Research Solutions, Inc.
🇺🇸Cypress, Texas, United States
Plaza Nephrology
🇺🇸Houston, Texas, United States
Texas Tech University Health
🇺🇸El Paso, Texas, United States
Clinical Research Strategies, Inc
🇺🇸Houston, 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
Lakeridge Health Corporation-Oshawa
🇨🇦Oshawa, Ontario, Canada
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States
St. George Hospital
🇦🇺Kogarah, New South Wales, Australia
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
🇨🇳New Taipei City, Taiwan
Torre Medica San Lucas
🇵🇷Ponce, Puerto Rico
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Taipei Medical University Hospital
🇨🇳Taipei City, Taiwan
Royal London Hospital
🇬🇧London, United Kingdom
San Miguel Medical
🇵🇷Trujillo Alto, Puerto Rico
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
Taipei Municipal Wanfang Hospital Managed by Taipei Medical University
🇨🇳Taipei, Taiwan