Print Send My Information

Purpose

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.

Conditions

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. 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.

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 injections) 		Participants randomized to the experimental arm will receive 2 injections of REACT.
  • 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, Arizona 85724
Contact:
Bijin Thajudeen, MD
520-626-0072

Amicis Research Center
Beverly Hills, California 90211
Contact:
Michael Levine, MD
818-924-4708

Kidney Consultants Medical Group
Granada Hills, California 91344
Contact:
Pascal Dabel, MD
818-924-4708

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

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

Northridge Kidney Care Center
Northridge, California 91324
Contact:
Brian Ayuste, MD
818-924-4708

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

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

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
916-734-3723

Henry Mayo Newhall Hospital
Valencia, California 91355
Contact:
Billy Hour, MD
818-924-4708

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

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

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

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

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

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

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

Holyoke Medical Center
Springfield, Massachusetts 01107
Contact:
Michael Germain, MD
413-222-4225

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

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

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

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

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

Texas Tech University Health
El Paso, Texas 79905
Contact:
Fernanda Payan-Schober, MD
915-215-6400

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

Biopharma Informatic, LLC
Houston, Texas 77043
Contact:
Agadadash Kuliev, MD
281-944-3610

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

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

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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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