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

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05099770
• Other study ID #: REGEN-006
• Status: Recruiting
• Phase: Phase 3
• Start date: January 5, 2022
• Est. completion date: February 2027

Study information

• Verified date: June 2024
• Source: Prokidney
• Contact: Elizabeth Lotz
• Phone: 919-294-4521
• Email: info[@]prokidney.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 685
• 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 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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes Mellitus

Intervention

Biological:
• Renal Autologous Cell Therapy (REACT)
Participants will have a kidney biopsy followed 14 weeks later with a REACT injection into the biopsied kidney, then, another 12 weeks (+28 days) later a REACT injection into their contralateral kidney.

Procedure:
• Sham Comparator
Participants will have 2 sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The second sham procedure will occur 12 weeks (+28 days) after the first sham procedure.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Prokidney

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Taiwan,  United Kingdom, 

Outcome

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: Change in eGFR	• Annualized change in eGFR	up to 60 Months
Secondary	Secondary Composite Endpoint: Change in eGFR from first injection	• Time from first injection to at least a 40% reduction in eGFR sustained for 30 days.	up to 60 Months
Secondary	Secondary Composite Endpoint: Change in eGFR from first injection to End Stage Renal Disease (ESRD)	• Time from first injection to eGFR < 15 mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or renal transplant.	up to 60 Months
Secondary	Secondary Composite Endpoint: Mortality	The time from first injection to all-cause mortality.	up to 60 Months
Secondary	Secondary Composite Endpoint: Quality of Life Changes	• 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.	up to 60 Months
Secondary	Secondary Composite Endpoint: Quality of Life	• 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).	up to 60 Months