RECRUITING

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

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Conditions

Type 2 Diabetes MellitusChronic Kidney DiseasesREACT®RilparencelProact

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT/rilparencel injections given 12 weeks (-14 days to +28 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.

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)

Quick Facts

Study Start:2022-01-05
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05099770

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. The participant is male or female, 30 to 80 years of age on the date of informed consent.
  2. 2. Documented diagnosis of type 2 diabetes mellitus (T2DM) and chronic kidney disease as the underlying cause of kidney disease (diagnosis does not have to be confirmed by kidney biopsy).
  3. 1. eGFR of at least 20 mL/min/1.73 m2 AND \<30 mL/min/1.73 m2, not requiring kidney dialysis. UACR level cannot exceed 5000 mg/g (565 mg/mmol), OR
  4. 2. eGFR of 30 to ≤ 35 mL/min/1.73m2 AND UACR of 300 to ≤ 5000 mg/g (33.9 mg/mmol to ≤565 mg/mmol).
  5. 3. Serum glycosylated hemoglobin (HbA1c) of 9.5% or lower at Screening.
  6. 4. Systolic blood pressure of ≤ 140 mm Hg and diastolic blood pressure of ≤ 90 mm Hg at Screening, based on average of 3 consecutive measurements obtained seated or supine. Note: Retesting may be performed if initial screening blood pressure exceeds eligibility criteria for systolic and/or diastolic blood pressure. Changes in blood pressure Page 46 of 113 CONFIDENTIAL ProKidney Renal Autologous Cell Therapy Clinical Protocol REGEN-006 USAN/INN: Rilparencel Version 6.0 medications will be recorded in the appropriate eCRF. (refer to BP procedures)
  7. 5. All participants should be strongly considered for treatment with sodium-glucose cotransporter 2 inhibitor (SGLT2i). For participants on SGLT2i medications, the dose must be stable for at least 4 weeks prior to randomization. Note: The reason for a participant NOT receiving SGLT2i therapy at the time of randomization will be documented in the eCRF. (See Section 7.1 for additional guidance about Concomitant Therapies).
  8. 6. On a clinically relevant, maximally tolerated dose of an angiotensin converting-enzyme inhibitor (ACEI) OR an angiotensin receptor blocker (ARB), unless not tolerated or contraindicated. The dose must be stable for at least 4 weeks prior to randomization. Note: The reason for a participant NOT receiving an ACEI or ARB at the time of randomization will be documented in the eCRF. (See Section 7.1 for additional guidance about Concomitant Therapies).
  9. 7. Participant agrees, and in the judgement of the Investigator, is able to refrain from using therapies that may increase bleeding risk for the specified pre-procedure and postprocedure (biopsy/sham biopsy and rilparencel/sham injections) durations in the discretion of the PI in consultation with the treating physician, in accordance with the required minimum medication-specific guidelines for high-risk procedures59 and patients with advanced CKD.
  10. * Nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen and naproxen
  11. * Aspirin
  12. * Platelet aggregation inhibitors (PAIs) such as clopidogrel, prasugrel, and dipyridamole
  13. * Factor Xa inhibitors
  14. * Warfarin
  15. * Heparin products
  16. * Other anticoagulation.
  17. 8. Participant is willing and able to cooperate with all aspects of the protocol.
  18. 9. Participant is willing and able to provide signed informed consent.
  1. 1. The participant has a history of type 1 diabetes mellitus.
  2. 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. 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 rilparencel injection procedure or confound study assessments.
  4. * Concomitant hypertension-related CKD
  5. * Anatomic abnormalities and benign conditions are not exclusionary if the kidney has accessible kidney cortex for biopsy and injection procedures and meets the criteria to receive the rilparencel injection.
  6. * Abnormalities on kidney biopsy (e.g., secondary focal segmental glomerulosclerosis) which are considered secondary to diabetes with the following conditions: lack of other identifiable etiology, full evaluation for other etiologies, no specific treatment administered other than diabetes management.
  7. 4. History of acute kidney injury or major surgery (based on the judgement of the Investigator and Medical Monitor) within 3 months prior to the Screening Visit.
  8. 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.
  9. 6. Current or history of heart failure of New York Heart Association (NYHA) Class IV cardiac disease.
  10. 7. History of malignancy within the past 3 years prior to Screening, except for basal cell and/or squamous cell carcinomas of the skin with apparent successful curative therapy, carcinoma of the cervix in situ, or a malignancy that in the opinion of the Investigator, along with agreement from the Medical Monitor, is considered treated with no evidence of disease and at minimal risk of recurrence.
  11. 8. Documented clinically significant liver disease, including acute or chronic hepatitis B or hepatitis C. Note: At the discretion of the Investigator, a participant who gives a history of a treated and cured Hepatitis C infection may be screened with a test for viral ribonucleic acid (RNA), and if a cure is demonstrated, the participant may be enrolled.
  12. 9. Known infection with HIV, active syphilis, or other unresolved active genitourinary infection, or active tuberculosis requiring treatment at Screening.

Contacts and Locations

Study Contact

Elizabeth Lotz
CONTACT
919-294-4521
info@prokidney.com
Catherine Taylor
CONTACT
919-294-4521
info@prokidney.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Prokidney

Study Locations (Sites)

University of Arizona
Tucson, Arizona, 85724
United States
Amicis Research Center
Beverly Hills, California, 90211
United States
Paradise Clinical Research Group LLC
Glendora, California, 91741
United States
Kidney Consultants Medical Group
Granada Hills, California, 91344
United States
IMD Clinical Trials
Huntington Park, California, 90255
United States
Advanced Medical Research, LLC
Lakewood, California, 90712
United States
Medicine and Nephrology Associates
Los Alamitos, California, 90720
United States
Academic Medical Research Institute
Los Angeles, California, 90022
United States
Southern California Hospital
Los Angeles, California, 90095
United States
Allameh Medical Corporation
Mission Viejo, California, 92691
United States
Golden Pacific Nephrology Medical Clinic Inc
Monterey Park, California, 91755
United States
Northridge Kidney Care Center
Northridge, California, 91324
United States
Valley Renal Medical Group
Northridge, California, 91324
United States
Valley Clinical Trials
Northridge, California, 91325
United States
Integrity Medical Discovery
Pico Rivera, California, 90660
United States
Nephrology Associates Medical Group
Riverside, California, 92505
United States
UC Davis Medical Group GI Unit
Sacramento, California, 95817
United States
North America Research Institute
San Dimas, California, 91773
United States
Henry Mayo Newhall Hospital
Valencia, California, 91355
United States
Nephrology Associates PA
Newark, Delaware, 19713
United States
West Broward Research Institute
Coral Springs, Florida, 33313
United States
Florida Kidney Physicians
Fort Lauderdale, Florida, 33316
United States
South Fort Lauderdale Nephrology
Fort Lauderdale, Florida, 33316
United States
University of Florida
Gainesville, Florida, 32608
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Ethos Palm Beach
Loxahatchee Groves, Florida, 33470
United States
Global Clinix, LLC
Miami, Florida, 33155
United States
Professional Research Center, Inc.
Miami, Florida, 33172
United States
New Phase Clinical Trials
Miami Beach, Florida, 33140
United States
Infigo Clinical Research
Sanford, Florida, 32771
United States
Genesis Clinical Research
Tampa, Florida, 33603
United States
American Clinical Trials
Acworth, Georgia, 30101
United States
Boise Kidney and Hypertension PLLC
Boise, Idaho, 83706
United States
Care Institute
Chubbuck, Idaho, 83202
United States
Insight Hospital & Medical Center Chicago
Chicago, Illinois, 60616
United States
The University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Indiana Nephrology
Fishers, Indiana, 46037
United States
University of Iowa
Iowa City, Iowa, 52242
United States
LSU Health Sciences Center
Shreveport, Louisiana, 71103
United States
Washington Nephrology Associates
Takoma Park, Maryland, 20854
United States
Holyoke Medical Center
Springfield, Massachusetts, 01107
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Nephrology Center, PC
Kalamazoo, Michigan, 49007
United States
St. Clair Nephrology Research
Roseville, Michigan, 48066
United States
Nephrology and Hypertension Associates
Tupelo, Mississippi, 38801
United States
Saint Louis University
St Louis, Missouri, 63110
United States
Nevada Kidney Disease & Hypertension Center
Las Vegas, Nevada, 89052
United States
Seacoast Kidney & Hypertension Specialists
Portsmouth, New Hampshire, 03801
United States
ICAHN School of Medicine at Mount Sinai
New York, New York, 10029
United States
Jacobi Medical Center
The Bronx, New York, 10461
United States
UNC Chapel Hill
Chapel Hill, North Carolina, 27514
United States
Lifespan Clinical Research Center
East Providence, Rhode Island, 02915
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Dunes Clinical Research
Dakota Dunes, South Dakota, 57049
United States
Knoxville Kidney Center
Knoxville, Tennessee, 37923
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Pioneer Research Solutions, Inc.
Cypress, Texas, 77429
United States
Texas Tech Health Sciences
El Paso, Texas, 79905
United States
Texas Tech University Health
El Paso, Texas, 79905
United States
Plaza Nephrology
Houston, Texas, 77004
United States
Biopharma Informatic, LLC
Houston, Texas, 77043
United States
Prolato Clinical Research Center
Houston, Texas, 77054
United States
Clinical Research Strategies, Inc
Houston, Texas, 77090
United States
United Memorial Medical Center
Houston, Texas, 77091
United States
Clinical Advancement Center, PLLC
San Antonio, Texas, 78212
United States
University Health System
San Antonio, Texas, 78229
United States
Prolato Clinical Research Center - Sugar Land
Sugar Land, Texas, 77479
United States
Renal Physicians of Montgomery County
The Woodlands, Texas, 77384
United States
Salem VA Medical Center
Salem, Virginia, 24153
United States
Providence Medical Research Ctr
Spokane, Washington, 99204
United States
University of Wisconsin-Madison
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Prokidney

  • Study Director, STUDY_DIRECTOR, Prokidney

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-05
Study Completion Date2027-02

Study Record Updates

Study Start Date2022-01-05
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • REACT®
  • Type 2 Diabetes Mellitus
  • Rilparencel
  • Proact

Additional Relevant MeSH Terms

  • Type 2 Diabetes Mellitus
  • Chronic Kidney Diseases