Clinical trial NCT05099770: Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Chronic Kidney Diseases
Keywords: REACT®
Type 2 Diabetes Mellitus
Rilparencel
Proact
Lead sponsor: Prokidney
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 685
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 9.5% at the Screening Visit.
5. 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).
6. 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.
7. 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.

Exclusion Criteria:

1. The participant has a history of type 1 diabetes mellitus.
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 REACT injection procedure or confound study assessments.
4. History of acute kidney injury 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.

Primary outcomes:
measure: Primary Composite Endpoint
timeFrame: up to 60 Months
Secondary outcomes:
measure: Secondary Composite Endpoint: Change in eGFR
timeFrame: up to 60 Months
measure: Secondary Composite Endpoint: Change in eGFR from first injection
timeFrame: up to 60 Months
measure: Secondary Composite Endpoint: Change in eGFR from first injection to End Stage Renal Disease (ESRD)
timeFrame: up to 60 Months
measure: Secondary Composite Endpoint: Mortality
timeFrame: up to 60 Months
measure: Secondary Composite Endpoint: Quality of Life Changes
timeFrame: up to 60 Months
measure: Secondary Composite Endpoint: Quality of Life
timeFrame: up to 60 Months
Other outcomes:
Locations:
city: Glendora
country: United States
facility: Paradise Clinical Research Group LLC
state: California
city: Granada Hills
country: United States
facility: Kidney Consultants Medical Group
state: California
city: Huntington Park
country: United States
facility: IMD Clinical Trials
state: California
city: Lakewood
country: United States
facility: Advanced Medical Research, LLC
state: California
city: Los Alamitos
country: United States
facility: Medicine and Nephrology Associates
state: California
city: Los Angeles
country: United States
facility: Academic Medical Research Institute
state: California
city: Mission Viejo
country: United States
facility: Allameh Medical Corporation
state: California
city: Monterey Park
country: United States
facility: Golden Pacific Nephrology Medical Clinic Inc
state: California
city: Northridge
country: United States
facility: Northridge Kidney Care Center
state: California
city: Northridge
country: United States
facility: Valley Renal Medical Group
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials
state: California
city: Pico Rivera
country: United States
facility: Integrity Medical Discovery
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Group GI Unit
state: California
city: San Dimas
country: United States
facility: North America Research Institute
state: California
city: Valencia
country: United States
facility: Henry Mayo Newhall Hospital
state: California
city: Newark
country: United States
facility: Nephrology Associates PA
state: Delaware
city: Coral Springs
country: United States
facility: West Broward Research Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: Florida Kidney Physicians
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami Beach
country: United States
facility: New Phase Clinical Trials
state: Florida
city: Miami
country: United States
facility: Global Clinix, LLC
state: Florida
city: Miami
country: United States
facility: Professional Research Center, Inc.
state: Florida
city: Sanford
country: United States
facility: Infigo Clinical Research
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research
state: Florida
city: Acworth
country: United States
facility: American Clinical Trials
state: Georgia
city: Boise
country: United States
facility: Boise Kidney and Hypertension PLLC
state: Idaho
city: Chubbuck
country: United States
facility: Care Institute
state: Idaho
city: Chicago
country: United States
facility: Insight Hospital & Medical Center Chicago
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Fishers
country: United States
facility: Indiana Nephrology
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Takoma Park
country: United States
facility: Washington Nephrology Associates
state: Maryland
city: Springfield
country: United States
facility: Holyoke Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Roseville
country: United States
facility: St. Clair Nephrology Research
state: Michigan
city: Tupelo
country: United States
facility: Nephrology and Hypertension Associates
state: Mississippi
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Kidney Disease & Hypertension Center
state: Nevada
city: Portsmouth
country: United States
facility: Seacoast Kidney & Hypertension Specialists
state: New Hampshire
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: East Providence
country: United States
facility: Lifespan Clinical Research Center
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Dakota Dunes
country: United States
facility: Dunes Clinical Research
state: South Dakota
city: Knoxville
country: United States
facility: Knoxville Kidney Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Cypress
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: El Paso
country: United States
facility: Texas Tech Health Sciences
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health
state: Texas
city: Houston
country: United States
facility: Plaza Nephrology
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Clinical Research Strategies, Inc
state: Texas
city: Houston
country: United States
facility: United Memorial Medical Center
state: Texas
city: The Woodlands
country: United States
facility: Renal Physicians of Montgomery County
state: Texas
city: Salem
country: United States
facility: Salem VA Medical Center
state: Virginia
city: Spokane
country: United States
facility: Providence Medical Research Ctr
state: Washington
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Kogarah
country: Australia
facility: St. George Hospital
state: New South Wales
city: Oshawa
country: Canada
facility: Lakeridge Health Corporation-Oshawa
state: Ontario
city: Ponce
country: Puerto Rico
facility: Torre Medica San Lucas
city: Trujillo Alto
country: Puerto Rico
facility: San Miguel Medical
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital Managed by Taipei Medical University
city: London
country: United Kingdom
facility: Royal London Hospital
Study officials:
affiliation: Prokidney
name: Study Director
role: STUDY_DIRECTOR
References: