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

Purpose

The purpose of this study is to assess the safety and efficacy of up to 2 REACT/rilparencel injections in participants with T2DM and CKD.

Conditions

  • Type 2 Diabetes Mellitus
  • Chronic Kidney Diseases

Eligibility

Eligible Ages
Between 30 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. The participant is male or female, 30 to 80 years of age on the date of informed consent. 2. Documented diagnosis of type 2 diabetes mellitus (T2DM) and chronic kidney disease 3. Serum glycosylated hemoglobin (HbA1c) of 9.5% or lower at Screening. 4. Systolic blood pressure of ≤ 140 mm Hg and diastolic blood pressure of ≤ 90 mm Hg at Screening. 5. All participants should be strongly considered for treatment with sodium-glucose cotransporter 2 inhibitor (SGLT2i). 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. 7. Participant agrees and is able to refrain from using therapies that may increase bleeding risk for the specified pre-procedure and post-procedure durations. 8. Participant is willing and able to cooperate with all aspects of the protocol and provide signed informed consent.

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 3. The participant has any other known underlying cause of kidney disease 4. History of acute kidney injury or major surgery within 3 months prior to the Screening Visit. 5. Myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before randomization, or a revascularization procedure is planned during the trial. 6. Current or history of heart failure of New York Heart Association (NYHA) Class IV cardiac disease. 7. History of exclusionary malignancy within the past 3 years prior to Screening 8. Documented clinically significant liver disease, including acute or chronic hepatitis B or hepatitis C. 9. Known infection with HIV, active syphilis, or other unresolved active genitourinary infection, or active tuberculosis requiring treatment at Screening. 10. Immunocompromised condition or condition requiring chronic immunosuppressive agents, including individuals treated for chronic glomerulonephritis, within 3 months of signing ICF. 11. Has had a recent bleeding event or a known bleeding disorder(s) or increased risk of either thromboembolism or bleeding. 12. Kidney imaging reveals contraindications for undergoing biopsy or rilparencel injection 13. Maintained on any anticoagulant agents 14. History of anaphylactic or severe systemic reaction(s) to blood transfusions, Dextran 40, or bovine products, or contraindication(s) to above products due to medical reasons or participant preference. 15. History of severe systemic reaction(s) or any contraindication to local anesthetics or sedatives. 16. Use of an investigational product or device within 12 weeks prior to Randomization or previous treatment with rilparencel. 17. Participant's health status would, in the judgement of the Investigator, be jeopardized by participating in the study.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Sham Comparator
Sham Procedure 		Participants randomized to the Sham Comparator arm will have 2 sham procedures.
  • Procedure: Sham Comparator
    Participants will have sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The 2 injection/ sham procedures will occur approximately 12 weeks apart.
Experimental
Experimental (REACT/rilparencel injections) 		Participants randomized to the experimental arm will receive 2 injections of REACT/ rilparencel.
  • Biological: Renal Autologous Cell Therapy (REACT/ rilparencel)
    Participants will have a kidney biopsy followed approximately12 weeks later with a rilparencel injection into the biopsied kidney, then, approximately 12 weeks later a rilparencel injection into their contralateral kidney.

Recruiting Locations

Nephrology Consultants
Huntsville, Alabama 35805
Contact:
David Baines, MD
256-827-5050

University of Arizona
Tucson, Arizona 85724
Contact:
Bijin Thajudeen, MD
520-626-0072

IMD Clinical Trials
Huntington Park, California 90255
Contact:
Victor Carabello, MD
323-868-4400

Advanced Medical Research, LLC
Lakewood, California 90712
Contact:
Adarsh Daswani, MD
562-867-8195

Medicine and Nephrology Associates
Los Alamitos, California 90720
Contact:
Victor Kabbany, MD
562-596-1667

Academic Medical Research Institute
Los Angeles, California 90022
Contact:
Mohamed El-Shahawy, MD
323-725-7149

Southern California Hospital
Los Angeles, California 90095
Contact:
Anjay Rastogi, MD
310-794-5024

Golden Pacific Nephrology Medical Clinic Inc
Monterey Park, California 91755
Contact:
Paul Hwu, MD
323-246-4955

Valley Renal Medical Group
Northridge, California 91324
Contact:
Renee Dua, MD
818-439-5031

Valley Clinical Trials
Northridge, California 91325
Contact:
Christopher Chow, MD
818-280-4220

National Institute of Clinical Research
Pomona, California 91768
Contact:
Tariq Shah, MD
909-766-8042

Nephrology Associates Medical Group
Riverside, California 92505
Contact:
Dalia Dawoud, MD
951-529-1829

UC Davis Medical Group GI Unit
Sacramento, California 95817
Contact:
Prasanth Surampudi, MD
916-734-8802

North America Research Institute
San Dimas, California 91773
Contact:
Aamir Jamal, MD
800-797-1695

Nephrology Associates PA
Newark, Delaware 19713
Contact:
Theodore Saad, MD
302-225-3618

South Fort Lauderdale Nephrology
Fort Lauderdale, Florida 33316
Contact:
Zachary Yablon, MD
516-851-2499

University of Florida
Gainesville, Florida 32608
Contact:
Mark Segal, MD
352-265-4845

Mayo Clinic
Jacksonville, Florida 32224
Contact:
LaTonya Hickson, MD
904-953-3057

Ethos Palm Beach
Loxahatchee Groves, Florida 33470
Contact:
Sayed Ali, MD
561-783-8065

Global Clinix, LLC
Miami, Florida 33155
Contact:
Jeffrey Maldonado, MD
305-900-4431

Professional Research Center, Inc.
Miami, Florida 33172
Contact:
Jorge Posada, MD
786-359-4091

New Phase Clinical Trials
Miami Beach, Florida 33140
Contact:
Letica Adan, MD
305-858-4300

Infigo Clinical Research
Sanford, Florida 32771
Contact:
Sayed Husain, MD
321-364-0728

Wellstar Health System
Augusta, Georgia 30912
Contact:
Laura Mulloy, DO
706-721-9547

Boise Kidney and Hypertension PLLC
Boise, Idaho 83706
Contact:
Arnold Silva, MD
208-615-4395

Care Institute
Chubbuck, Idaho 83202
Contact:
Hira Siktel, MD
208-904-4780

Insight Hospital & Medical Center Chicago
Chicago, Illinois 60616
Contact:
Rizwan Moinuddin, MD
312-567-2000

Indiana Nephrology
Fishers, Indiana 46037
Contact:
Ravneet Dhillon, MD
505-340-8101

Fresenius Kidney Care Mishawaka
Mishawaka, Indiana 46545
Contact:
Sudhir Vyakaranam, MD
574-273-6776

University of Iowa
Iowa City, Iowa 52242
Contact:
Mony Fraer, MD
319-356-4409

Nephrology Associates of Lexington
Lexington, Kentucky 40504
Contact:
Muhammed Atiq, MD
859-276-2157

LSU Health Sciences Center
Shreveport, Louisiana 71103
Contact:
Bharat Sachdeva, MD
520-626-0072

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Karthik Ramani, MD
734-615-1518

Nephrology Center, PC
Kalamazoo, Michigan 49007
Contact:
Ahmed Aqeel, MD
269-249-8445

Southwest MS Nephrology
Brookhaven, Mississippi 39601
Contact:
Paul Dykes, MD
601-835-4330

Nephrology Associates
Columbus, Mississippi 39705
Contact:
Angela Riley, MD
662-329-3838

Nephrology and Hypertension Associates
Tupelo, Mississippi 38801
Contact:
Thomas Wooldridge, MD
662-844-4711

Seacoast Kidney & Hypertension Specialists
Portsmouth, New Hampshire 03801
Contact:
Sucharit Joshi, MD
603-436-3433

NYU Langone
New York, New York 10017
Contact:
Sindhuri Prakash-Polet, MD
646-501-8453

ICAHN School of Medicine at Mount Sinai
New York, New York 10029
Contact:
Steven Coca, MD
929-641-0971

Jacobi Medical Center
The Bronx, New York 10461
Contact:
Anjali Acharya, MD
718-918-6212

UNC Chapel Hill
Chapel Hill, North Carolina 27514
Contact:
Randy Detwiler, MD
919-843-0832

Lifespan Clinical Research Center
East Providence, Rhode Island 02915
Contact:
George Bayliss, MD
401-444-8728

Dunes Clinical Research
Dakota Dunes, South Dakota 57049
Contact:
Ashar Luqman, MD
605-217-7749

Knoxville Kidney Center
Knoxville, Tennessee 37923
Contact:
Kendra Hendon, MD
865-692-3462

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Anna Burgner, MD
615-936-1179

Pioneer Research Solutions, Inc.
Cypress, Texas 77429
Contact:
Rahul Pandey, MD
713-333-9323

Plaza Nephrology
Houston, Texas 77004
Contact:
Justin Merszei, MD
713-520-6790

Prolato Clinical Research Center
Houston, Texas 77054
Contact:
Sreedhar Mandayam, MD
832-338-9118

Clinical Research Strategies, Inc
Houston, Texas 77090
Contact:
Christopher Kwoh, MD

United Memorial Medical Center
Houston, Texas 77091
Contact:
Wasae Tabibi, MD
281-618-8500

Clinical Advancement Center, PLLC
San Antonio, Texas 78212
Contact:
Pablo Pergola, MD
210-223-4444

University Health System
San Antonio, Texas 78229
Contact:
Shweta Bansal, MD
210-743-6450

Prolato Clinical Research Center - Sugar Land
Sugar Land, Texas 77479
Contact:
Biruh Workeneh, MD
832-338-9118

Renal Physicians of Montgomery County
The Woodlands, Texas 77384
Contact:
Harini Bejjanki, MD
936-331-8456

Salem VA Medical Center
Salem, Virginia 24153
Contact:
Devasmita Dev, MD
540-982-2463

Providence Medical Research Ctr
Spokane, Washington 99204
Contact:
Radica Alicic, MD
509-474-4345

University of Wisconsin-Madison
Madison, Wisconsin 53792
Contact:
Ali Gardezi, MD
608-608-6400

Torre Medica San Lucas
Ponce, Puerto Rico 00716
Contact:
Felix Perez Ramos, MD
787-955 0800

San Miguel Medical
Trujillo Alto, Puerto Rico 00976
Contact:
Elba Perez-Vargas, MD
787-748-7105

More Details

NCT ID
NCT05099770
Status
Recruiting
Sponsor
Prokidney

Study Contact

ProKidney Call Center
(866)955 4394
proact1@careboxhealth.com

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 have scripted sham procedures that mimic the sounds and activities of biopsy, injection procedures, and evaluations as a control for Cohort 2 participants who will have a kidney biopsy followed with a rilparencel injection into the biopsied kidney, then, approximately 12 weeks later with a second rilparencel injection into the contralateral kidney. All participants will be followed until the global trial end date is declared.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center