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 (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.

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 as the underlying cause of kidney disease (diagnosis does not have to be confirmed by kidney biopsy). 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 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). 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, 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) 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). 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). 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. - Nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen and naproxen - Aspirin - Platelet aggregation inhibitors (PAIs) such as clopidogrel, prasugrel, and dipyridamole - Factor Xa inhibitors - Warfarin - Heparin products - Other anticoagulation. 8. Participant is willing and able to cooperate with all aspects of the protocol. 9. Participant is willing and able to 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 (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 rilparencel injection procedure or confound study assessments. Note: The following are not considered exclusionary under the following conditions: (Unique situations should be discussed with the study Medical Monitor.) - Concomitant hypertension-related CKD - 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. - 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. 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. 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. 6. Current or history of heart failure of New York Heart Association (NYHA) Class IV cardiac disease. 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. 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. 9. Known infection with HIV, active syphilis, or other unresolved active genitourinary infection, or active tuberculosis requiring treatment at Screening.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, 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 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.
Experimental
Experimental (REACT/rilparencel injections) 		Participants randomized to the experimental arm will receive 2 injections of REACT/ rilparencel.
  • 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.

Recruiting Locations

University of Arizona
Tucson 5318313, Arizona 5551752 85724
Contact:
Bijin Thajudeen, MD
520-626-0072

IMD Clinical Trials
Huntington Park 5358736, California 5332921 90255
Contact:
Victor Carabello, MD
323-868-4400

Advanced Medical Research, LLC
Lakewood 5364855, California 5332921 90712
Contact:
Adarsh Daswani, MD
562-867-8195

Medicine and Nephrology Associates
Los Alamitos 5368304, California 5332921 90720
Contact:
Victor Kabbany, MD
562-596-1667

Academic Medical Research Institute
Los Angeles 5368361, California 5332921 90022
Contact:
Mohamed El-Shahawy, MD
323-725-7149

Southern California Hospital
Los Angeles 5368361, California 5332921 90095
Contact:
Anjay Rastogi, MD
310-794-5024

Golden Pacific Nephrology Medical Clinic Inc
Monterey Park 5374406, California 5332921 91755
Contact:
Paul Hwu, MD
323-246-4955

Valley Renal Medical Group
Northridge 5377985, California 5332921 91324
Contact:
Sohan Dua, MD
818-439-5031

Valley Clinical Trials
Northridge 5377985, California 5332921 91325
Contact:
Christopher Chow, MD
818-280-4220

Nephrology Associates Medical Group
Riverside 5387877, California 5332921 92505
Contact:
Dalia Dawoud, MD
951-529-1829

UC Davis Medical Group GI Unit
Sacramento 5389489, California 5332921 95817
Contact:
Prasanth Surampudi, MD
916-734-8802

North America Research Institute
San Dimas 5391891, California 5332921 91773
Contact:
Aamir Jamal, MD
800-797-1695

Nephrology Associates PA
Newark 4143861, Delaware 4142224 19713
Contact:
Theodore Saad, MD
302-225-3618

South Fort Lauderdale Nephrology
Fort Lauderdale 4155966, Florida 4155751 33316
Contact:
Zachary Yablon, MD
516-851-2499

University of Florida
Gainesville 4156404, Florida 4155751 32608
Contact:
Mark Segal, MD
352-265-4845

Mayo Clinic
Jacksonville 4160021, Florida 4155751 32224
Contact:
LaTonya Hickson, MD
904-953-3057

Ethos Palm Beach
Loxahatchee Groves 4162948, Florida 4155751 33470
Contact:
Sayed Ali, MD
561-783-8065

Global Clinix, LLC
Miami 4164138, Florida 4155751 33155
Contact:
Jeffrey Maldonado, MD
305-900-4431

Professional Research Center, Inc.
Miami 4164138, Florida 4155751 33172
Contact:
Jorge Posada, MD
786-359-4091

New Phase Clinical Trials
Miami Beach 4164143, Florida 4155751 33140
Contact:
Letica Adan, MD
305-858-4300

Infigo Clinical Research
Sanford 4172086, Florida 4155751 32771
Contact:
Sayed Husain, MD
321-364-0728

Boise Kidney and Hypertension PLLC
Boise 5586437, Idaho 5596512 83706
Contact:
Arnold Silva, MD
208-615-4395

Care Institute
Chubbuck 5588842, Idaho 5596512 83202
Contact:
Hira Siktel, MD
208-904-4780

Insight Hospital & Medical Center Chicago
Chicago 4887398, Illinois 4896861 60616
Contact:
Rizwan Moinuddin, MD
312-567-2000

Indiana Nephrology
Fishers 4257494, Indiana 4921868 46037
Contact:
Ravneet Dhillon, MD
505-340-8101

University of Iowa
Iowa City 4862034, Iowa 4862182 52242
Contact:
Mony Fraer, MD
319-356-4409

LSU Health Sciences Center
Shreveport 4341513, Louisiana 4331987 71103
Contact:
Bharat Sachdeva, MD
520-626-0072

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
Contact:
Karthik Ramani, MD
734-615-1518

Nephrology Center, PC
Kalamazoo 4997787, Michigan 5001836 49007
Contact:
Ahmed Aqeel, MD
269-249-8445

Nephrology and Hypertension Associates
Tupelo 4448903, Mississippi 4436296 38801
Contact:
Thomas Wooldridge, MD
662-844-4711

Seacoast Kidney & Hypertension Specialists
Portsmouth 5091383, New Hampshire 5090174 03801
Contact:
Sucharit Joshi, MD
603-436-3433

ICAHN School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
Contact:
Steven Coca, MD
929-641-0971

Jacobi Medical Center
The Bronx 5110266, New York 5128638 10461
Contact:
Anjali Acharya, MD
718-918-6212

UNC Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27514
Contact:
Randy Detwiler, MD
919-843-0832

Lifespan Clinical Research Center
East Providence 5221931, Rhode Island 5224323 02915
Contact:
George Bayliss, MD
401-444-8728

Dunes Clinical Research
Dakota Dunes 5227180, South Dakota 5769223 57049
Contact:
Ashar Luqman, MD
605-217-7749

Knoxville Kidney Center
Knoxville 4634946, Tennessee 4662168 37923
Contact:
Kendra Hendon, MD
865-692-3462

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
Contact:
Anna Burgner, MD
615-936-1179

Pioneer Research Solutions, Inc.
Cypress 4684724, Texas 4736286 77429
Contact:
Rahul Pandey, MD
713-333-9323

Plaza Nephrology
Houston 4699066, Texas 4736286 77004
Contact:
Justin Merszei, MD
713-520-6790

Prolato Clinical Research Center
Houston 4699066, Texas 4736286 77054
Contact:
Sreedhar Mandayam, MD
832-338-9118

Clinical Research Strategies, Inc
Houston 4699066, Texas 4736286 77090
Contact:
Christopher Kwoh, MD

United Memorial Medical Center
Houston 4699066, Texas 4736286 77091
Contact:
Wasae Tabibi, MD
281-618-8500

Clinical Advancement Center, PLLC
San Antonio 4726206, Texas 4736286 78212
Contact:
Pablo Pergola, MD
210-223-4444

University Health System
San Antonio 4726206, Texas 4736286 78229
Contact:
Shweta Bansal, MD
210-743-6450

Prolato Clinical Research Center - Sugar Land
Sugar Land 4734825, Texas 4736286 77479
Contact:
Biruh Workeneh, MD
832-338-9118

Renal Physicians of Montgomery County
The Woodlands 4736476, Texas 4736286 77384
Contact:
Harini Bejjanki, MD
936-331-8456

Salem VA Medical Center
Salem 4784112, Virginia 6254928 24153
Contact:
Devasmita Dev, MD
540-982-2463

Providence Medical Research Ctr
Spokane 5811696, Washington 5815135 99204
Contact:
Radica Alicic, MD
509-474-4345

University of Wisconsin-Madison
Madison 5261457, Wisconsin 5279468 53792
Contact:
Ali Gardezi, MD
608-608-6400

Torre Medica San Lucas
Ponce 4566880, Puerto Rico 00716
Contact:
Felix Perez Ramos, MD
787-955 0800

San Miguel Medical
Trujillo Alto 4568451, Puerto Rico 00976
Contact:
Elba Perez-Vargas, MD
787-748-7105

More Details

NCT ID
NCT05099770
Status
Recruiting
Sponsor
Prokidney

Study Contact

Elizabeth Lotz
919-294-4521
info@prokidney.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 12 weeks later with a rilparencel injection into the biopsied kidney, then, another 12 weeks later, a rilparencel injection into the contralateral kidney. All participants will be followed to the global trial end date. This event driven study is estimated to have a total maximum duration of 5 years.

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