Type 2 Diabetes Mellitus Clinical Trial
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)
Verified date | December 2023 |
Source | Prokidney |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 600 |
Est. completion date | February 2027 |
Est. primary completion date | February 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. The participant is male or female, 30 to 80 years of age on the date of informed consent. 2. The participant has a clinical diagnosis of T2DM in their health record. 3. 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. 4. The participant has a serum glycosylated hemoglobin (HbA1c) less than 10% at the Screening Visit. 5. The participant has a documented clinical diagnosis of an eGFR greater than or equal to 20 and less than or equal to 50 mL/min/1.73m², not requiring renal dialysis. 6. The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than or equal to 300 and less than or equal to 5,000 mg/g. Exclusion Criteria: 1. The participant has a history of type 1 diabetes mellitus. 2. The participant has a history of renal transplantation. 3. The participant has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening, across 3 measurements while seated. 4. The participant has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization. |
Country | Name | City | State |
---|---|---|---|
Australia | St. George Hospital | Kogarah | New South Wales |
Canada | Lakeridge Health Corporation-Oshawa | Oshawa | Ontario |
Taiwan | 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 | Taipei Municipal Wanfang Hospital Managed by Taipei Medical University | Taipei | |
Taiwan | Tri-Service General Hospital | Taipei | |
Taiwan | Taipei Medical University Hospital | Taipei City | |
United Kingdom | Royal London Hospital | London | |
United States | American Clinical Trials | Acworth | Georgia |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Boise Kidney and Hypertension Institute | Boise | Idaho |
United States | UNC Chapel Hill | Chapel Hill | North Carolina |
United States | Insight Hospital & Medical Center Chicago | Chicago | Illinois |
United States | The University of Chicago Medical Center | Chicago | Illinois |
United States | Care Institute | Chubbuck | Idaho |
United States | West Broward Research Institute | Coral Springs | Florida |
United States | Dunes Clinical Research | Dakota Dunes | South Dakota |
United States | Texas Tech Health Sciences | El Paso | Texas |
United States | Florida Kidney Physicians | Fort Lauderdale | Florida |
United States | University of Florida | Gainesville | Florida |
United States | Paradise Clinical Research Group LLC | Glendora | California |
United States | Clinical Research Strategies, Inc | Houston | Texas |
United States | Plaza Nephrology | Houston | Texas |
United States | United Memorial Medical Center | Houston | Texas |
United States | IMD Clinical Trials | Huntington Park | California |
United States | University of Iowa | Iowa City | Iowa |
United States | Knoxville Kidney Center | Knoxville | Tennessee |
United States | Advanced Medical Research, LLC | Lakewood | California |
United States | Nevada Kidney Disease & Hypertension Center | Las Vegas | Nevada |
United States | Medicine and Nephrology Associates | Los Alamitos | California |
United States | Academic Medical Research Institute | Los Angeles | California |
United States | University of Wisconsin-Madison | Madison | Wisconsin |
United States | New Phase Clinical Trials | Miami Beach | Florida |
United States | Allameh Medical Corporation | Mission Viejo | California |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Valley Clinical Trials | Northridge | California |
United States | Integrity Medical Discovery | Pico Rivera | California |
United States | Seacoast Kidney & Hypertension Specialists | Portsmouth | New Hampshire |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | St. Clair Nephrology Research | Roseville | Michigan |
United States | UC Davis Medical Group GI Unit | Sacramento | California |
United States | Saint Louis University | Saint Louis | Missouri |
United States | North America Research Institute | San Dimas | California |
United States | Washington Nephrology Associates | Takoma Park | Maryland |
United States | Genesis Clinical Research | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Prokidney | Iqvia Pty Ltd, PPD |
United States, Australia, Canada, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Composite Endpoint | 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 |
up to 60 Months | |
Secondary | Secondary Composite Endpoint | 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 Increase of UACR of at least 30% and of at least 30mg/g, using the random urine microalbumin/urine creatinine ratio sustained for 90 days or Renal or Cardiovascular death |
up to 60 Months |
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