A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

Phase 3

Recruiting

• Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Diseases
• Interventions: Procedure: Sham Comparator; Biological: 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-29
• Study Start: 2022-01-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 685

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.

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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.

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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 (55)

Valley Renal Medical Group; 🇺🇸 Northridge, California, United States

Infigo Clinical Research; 🇺🇸 Sanford, Florida, United States

Holyoke Medical Center; 🇺🇸 Springfield, Massachusetts, United States

Nephrology and Hypertension Associates; 🇺🇸 Tupelo, Mississippi, United States

Lifespan Clinical Research Center; 🇺🇸 East Providence, Rhode Island, United States

Pioneer Research Solutions, Inc.; 🇺🇸 Cypress, Texas, United States

Biopharma Informatic, LLC; 🇺🇸 Houston, Texas, United States

Renal Physicians of Montgomery County; 🇺🇸 The Woodlands, Texas, United States

Salem VA Medical Center; 🇺🇸 Salem, Virginia, United States

Paradise Clinical Research Group LLC; 🇺🇸 Glendora, 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

Allameh Medical Corporation; 🇺🇸 Mission Viejo, 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

North America Research Institute; 🇺🇸 San Dimas, California, United States

West Broward Research Institute; 🇺🇸 Coral Springs, Florida, United States

Florida Kidney Physicians; 🇺🇸 Fort Lauderdale, Florida, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

New Phase Clinical Trials; 🇺🇸 Miami Beach, Florida, United States

Genesis Clinical Research; 🇺🇸 Tampa, Florida, United States

American Clinical Trials; 🇺🇸 Acworth, Georgia, United States

Boise Kidney and Hypertension Institute; 🇺🇸 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

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Washington Nephrology Associates; 🇺🇸 Takoma Park, Maryland, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

St. Clair Nephrology Research; 🇺🇸 Roseville, Michigan, United States

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States

Nevada Kidney Disease & Hypertension Center; 🇺🇸 Las Vegas, Nevada, United States

Seacoast Kidney & Hypertension Specialists; 🇺🇸 Portsmouth, New Hampshire, United States

UNC Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, 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

Texas Tech Health Sciences; 🇺🇸 El Paso, Texas, United States

Plaza Nephrology; 🇺🇸 Houston, Texas, United States

Clinical Research Strategies, Inc; 🇺🇸 Houston, Texas, United States

United Memorial Medical Center; 🇺🇸 Houston, Texas, 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

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 Medical University Hospital; 🇨🇳 Taipei City, Taiwan

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan

Taipei Municipal Wanfang Hospital Managed by Taipei Medical University; 🇨🇳 Taipei, Taiwan

Royal London Hospital; 🇬🇧 London, United Kingdom