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

March 18, 2026 updated by: Prokidney

A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease (REGEN-006)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

685

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Withdrawn
        • St. George Hospital
  • Canada
    • Ontario
      • Oshawa, Ontario, Canada
        • Withdrawn
        • Lakeridge Health Corporation-Oshawa
  • Mexico
    • Mexico City
      • Tlalpan, Mexico City, Mexico, 14080
        • Recruiting
        • "Ignacio Chavez" National Cardiology Institute
        • Contact:
          • Magdalena Madero, MD
          • Phone Number: 21421 +525555732911
      • Tlalpan, Mexico City, Mexico, 14080
        • Recruiting
        • National Institute of Medical Sciences and Nutrition Salvador Zubiran
        • Contact:
          • Luis Morales, MD
          • Phone Number: +525585785655
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Recruiting
        • Torre Medica San Lucas
        • Contact:
          • Felix Perez Ramos, MD
          • Phone Number: 787-955 0800
      • Trujillo Alto, Puerto Rico, 00976
        • Recruiting
        • San Miguel Medical
        • Contact:
          • Elba Perez-Vargas, MD
          • Phone Number: 787-748-7105
  • Taiwan
      • New Taipei City, Taiwan, 23561
        • Recruiting
        • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
        • Contact:
          • Mai-Szu Wu, MD
          • Phone Number: 886970405050
      • New Taipei City, Taiwan, 220
        • Suspended
        • Far Eastern Memorial Hospital
      • Taichung, Taiwan, 40447
        • Active, not recruiting
        • China Medical University Hospital
      • Taichung, Taiwan
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
          • Ming-Ju Wu, MD
          • Phone Number: (+886) 911-710-132
      • Taipei, Taiwan, 11490
        • Recruiting
        • Tri-Service General Hospital
        • Contact:
          • Yu-Juei Hsu, MD
          • Phone Number: 886958004682
      • Taipei, Taiwan, 110
        • Recruiting
        • Taipei Medical University Hospital
        • Contact:
          • Chin-Chin Kao, MD
          • Phone Number: +8862273721813577
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Vin-Cent Wu, MD
          • Phone Number: (886) 932-396-341
      • Taipei, Taiwan
        • Recruiting
        • Taipei Municipal Wanfang Hospital
        • Contact:
          • Chung-Yi Cheng, MD
          • Phone Number: +886-928-692-458
      • Taipei, Taiwan, 116
        • Active, not recruiting
        • Taipei Municipal Wanfang Hospital Managed by Taipei Medical University
  • United Kingdom
      • London, United Kingdom, E1 1FR
        • Withdrawn
        • Royal London Hospital
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Recruiting
        • Nephrology Consultants
        • Contact:
          • David Baines, MD
          • Phone Number: 256-827-5050
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona
        • Contact:
          • Bijin Thajudeen, MD
          • Phone Number: 520-626-0072
    • California
      • Beverly Hills, California, United States, 90211
        • Active, not recruiting
        • Amicis Research Center
      • Glendora, California, United States, 91741
        • Withdrawn
        • Paradise Clinical Research Group LLC
      • Granada Hills, California, United States, 91344
        • Active, not recruiting
        • Kidney Consultants Medical Group
      • Huntington Park, California, United States, 90255
        • Recruiting
        • IMD Clinical Trials
        • Contact:
          • Victor Carabello, MD
          • Phone Number: 323-868-4400
      • Lakewood, California, United States, 90712
        • Recruiting
        • Advanced Medical Research, LLC
        • Contact:
          • Adarsh Daswani, MD
          • Phone Number: 562-867-8195
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Medicine and Nephrology Associates
        • Contact:
          • Victor Kabbany, MD
          • Phone Number: 562-596-1667
      • Los Angeles, California, United States, 90022
        • Recruiting
        • Academic Medical Research Institute
        • Contact:
          • Mohamed El-Shahawy, MD
          • Phone Number: 323-725-7149
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Southern California Hospital
        • Contact:
          • Anjay Rastogi, MD
          • Phone Number: 310-794-5024
      • Mission Viejo, California, United States, 92691
        • Completed
        • Allameh Medical Corporation
      • Monterey Park, California, United States, 91755
        • Recruiting
        • Golden Pacific Nephrology Medical Clinic Inc
        • Contact:
          • Paul Hwu, MD
          • Phone Number: 323-246-4955
      • Northridge, California, United States, 91325
        • Recruiting
        • Valley Clinical Trials
        • Contact:
          • Christopher Chow, MD
          • Phone Number: 818-280-4220
      • Northridge, California, United States, 91324
        • Recruiting
        • Valley Renal Medical Group
        • Contact:
          • Renee Dua, MD
          • Phone Number: 818-439-5031
      • Northridge, California, United States, 91324
        • Active, not recruiting
        • Northridge Kidney Care Center
      • Pico Rivera, California, United States, 90660
        • Active, not recruiting
        • Integrity Medical Discovery
      • Pomona, California, United States, 91768
        • Recruiting
        • National Institute of Clinical Research
        • Contact:
          • Tariq Shah, MD
          • Phone Number: 909-766-8042
      • Riverside, California, United States, 92505
        • Recruiting
        • Nephrology Associates Medical Group
        • Contact:
          • Dalia Dawoud, MD
          • Phone Number: 951-529-1829
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Medical Group GI Unit
        • Contact:
          • Prasanth Surampudi, MD
          • Phone Number: 916-734-8802
        • Contact:
          • Morgan Balaban
          • Phone Number: (916) 734 8802
      • San Dimas, California, United States, 91773
        • Recruiting
        • North America Research Institute
        • Contact:
          • Aamir Jamal, MD
          • Phone Number: 800-797-1695
      • Valencia, California, United States, 91355
        • Active, not recruiting
        • Henry Mayo Newhall Hospital
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Nephrology Associates PA
        • Contact:
          • Theodore Saad, MD
          • Phone Number: 302-225-3618
    • Florida
      • Coral Springs, Florida, United States, 33313
        • Active, not recruiting
        • West Broward Research Institute
      • Fort Lauderdale, Florida, United States, 33316
        • Completed
        • Florida Kidney Physicians
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • South Fort Lauderdale Nephrology
        • Contact:
          • Zachary Yablon, MD
          • Phone Number: 516-851-2499
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida
        • Contact:
          • Mark Segal, MD
          • Phone Number: 352-265-4845
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic
        • Contact:
          • LaTonya Hickson, MD
          • Phone Number: 904-953-3057
      • Loxahatchee Groves, Florida, United States, 33470
        • Recruiting
        • Ethos Palm Beach
        • Contact:
          • Sayed Ali, MD
          • Phone Number: 561-783-8065
      • Miami, Florida, United States, 33155
        • Recruiting
        • Global Clinix, LLC
        • Contact:
          • Jeffrey Maldonado, MD
          • Phone Number: 305-900-4431
      • Miami, Florida, United States, 33172
        • Recruiting
        • Professional Research Center, Inc.
        • Contact:
          • Jorge Posada, MD
          • Phone Number: 786-359-4091
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • New Phase Clinical Trials
        • Contact:
          • Letica Adan, MD
          • Phone Number: 305-858-4300
      • Sanford, Florida, United States, 32771
        • Recruiting
        • Infigo Clinical Research
        • Contact:
          • Sayed Husain, MD
          • Phone Number: 321-364-0728
      • Tampa, Florida, United States, 33603
        • Completed
        • Genesis Clinical Research
    • Georgia
      • Acworth, Georgia, United States, 30101
        • Terminated
        • American Clinical Trials
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Wellstar Health System
        • Contact:
          • Laura Mulloy, DO
          • Phone Number: 706-721-9547
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Boise Kidney and Hypertension PLLC
        • Contact:
          • Arnold Silva, MD
          • Phone Number: 208-615-4395
      • Chubbuck, Idaho, United States, 83202
        • Recruiting
        • CARE Institute
        • Contact:
          • Hira Siktel, MD
          • Phone Number: 208-904-4780
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Active, not recruiting
        • The University of Chicago Medical Center
      • Chicago, Illinois, United States, 60616
        • Recruiting
        • Insight Hospital & Medical Center Chicago
        • Contact:
          • Rizwan Moinuddin, MD
          • Phone Number: 312-567-2000
    • Indiana
      • Fishers, Indiana, United States, 46037
        • Recruiting
        • Indiana Nephrology
        • Contact:
          • Ravneet Dhillon, MD
          • Phone Number: 505-340-8101
      • Mishawaka, Indiana, United States, 46545
        • Recruiting
        • Fresenius Kidney Care Mishawaka
        • Contact:
          • Sudhir Vyakaranam, MD
          • Phone Number: 574-273-6776
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
          • Mony Fraer, MD
          • Phone Number: 319-356-4409
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Recruiting
        • Nephrology Associates of Lexington
        • Contact:
          • Muhammed Atiq, MD
          • Phone Number: 859-276-2157
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • LSU Health Sciences Center
        • Contact:
          • Bharat Sachdeva, MD
          • Phone Number: 520-626-0072
    • Maryland
      • Takoma Park, Maryland, United States, 20854
        • Completed
        • Washington Nephrology Associates
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Suspended
        • Holyoke Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
          • Karthik Ramani, MD
          • Phone Number: 734-615-1518
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Nephrology Center, PC
        • Contact:
          • Ahmed Aqeel, MD
          • Phone Number: 269-249-8445
      • Roseville, Michigan, United States, 48066
        • Suspended
        • St. Clair Nephrology Research
    • Mississippi
      • Brookhaven, Mississippi, United States, 39601
        • Recruiting
        • Southwest MS Nephrology
        • Contact:
          • Paul Dykes, MD
          • Phone Number: 601-835-4330
      • Columbus, Mississippi, United States, 39705
        • Recruiting
        • Nephrology Associates
        • Contact:
          • Angela Riley, MD
          • Phone Number: 662-329-3838
      • Tupelo, Mississippi, United States, 38801
        • Recruiting
        • Nephrology and Hypertension Associates
        • Contact:
          • Thomas Wooldridge, MD
          • Phone Number: 662-844-4711
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Withdrawn
        • Saint Louis University
    • Nevada
      • Las Vegas, Nevada, United States, 89052
        • Withdrawn
        • Nevada Kidney Disease & Hypertension Center
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Recruiting
        • Seacoast Kidney & Hypertension Specialists
        • Contact:
          • Sucharit Joshi, MD
          • Phone Number: 603-436-3433
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • ICAHN School of Medicine at Mount Sinai
        • Contact:
          • Steven Coca, MD
          • Phone Number: 929-641-0971
      • New York, New York, United States, 10017
        • Recruiting
        • NYU Langone
        • Contact:
          • Sindhuri Prakash-Polet, MD
          • Phone Number: 646-501-8453
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Jacobi Medical Center
        • Contact:
          • Anjali Acharya, MD
          • Phone Number: 718-918-6212
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • UNC Chapel Hill
        • Contact:
          • Randy Detwiler, MD
          • Phone Number: 919-843-0832
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • Recruiting
        • Lifespan Clinical Research Center
        • Contact:
          • George Bayliss, MD
          • Phone Number: 401-444-8728
      • Providence, Rhode Island, United States, 02903
        • Withdrawn
        • Rhode Island Hospital
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Recruiting
        • Dunes Clinical Research
        • Contact:
          • Ashar Luqman, MD
          • Phone Number: 605-217-7749
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Recruiting
        • Knoxville Kidney Center
        • Contact:
          • Kendra Hendon, MD
          • Phone Number: 865-692-3462
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Anna Burgner, MD
          • Phone Number: 615-936-1179
    • Texas
      • Cypress, Texas, United States, 77429
        • Recruiting
        • Pioneer Research Solutions, Inc.
        • Contact:
          • Rahul Pandey, MD
          • Phone Number: 713-333-9323
      • El Paso, Texas, United States, 79905
        • Completed
        • Texas Tech Health Sciences
      • El Paso, Texas, United States, 79905
        • Active, not recruiting
        • Texas Tech University Health
      • Houston, Texas, United States, 77054
        • Recruiting
        • Prolato Clinical Research Center
        • Contact:
          • Sreedhar Mandayam, MD
          • Phone Number: 832-338-9118
      • Houston, Texas, United States, 77090
        • Recruiting
        • Clinical Research Strategies, Inc
        • Contact:
          • Christopher Kwoh, MD
      • Houston, Texas, United States, 77091
        • Recruiting
        • United Memorial Medical Center
        • Contact:
          • Wasae Tabibi, MD
          • Phone Number: 281-618-8500
      • Houston, Texas, United States, 77004
        • Recruiting
        • Plaza Nephrology
        • Contact:
          • Justin Merszei, MD
          • Phone Number: 713-520-6790
      • Houston, Texas, United States, 77043
        • Suspended
        • Biopharma Informatic, LLC
      • San Antonio, Texas, United States, 78212
        • Recruiting
        • Clinical Advancement Center, PLLC
        • Contact:
          • Pablo Pergola, MD
          • Phone Number: 210-223-4444
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University Health System
        • Contact:
          • Shweta Bansal, MD
          • Phone Number: 210-743-6450
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Prolato Clinical Research Center - Sugar Land
        • Contact:
          • Biruh Workeneh, MD
          • Phone Number: 832-338-9118
      • The Woodlands, Texas, United States, 77384
        • Recruiting
        • Renal Physicians of Montgomery County
        • Contact:
          • Harini Bejjanki, MD
          • Phone Number: 936-331-8456
    • Virginia
      • Salem, Virginia, United States, 24153
        • Recruiting
        • Salem VA Medical Center
        • Contact:
          • Devasmita Dev, MD
          • Phone Number: 4663 540-982-2463
    • Washington
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Medical Research Ctr
        • Contact:
          • Radica Alicic, MD
          • Phone Number: 509-474-4345
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin-Madison
        • Contact:
          • Ali Gardezi, MD
          • Phone Number: 608-608-6400

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.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key 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.

Key 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surrogate / Intermediate Efficacy Endpoint -eGFR Slope
Time Frame: 18 months after the 135th participant receives their first injection / sham.
The difference in annualized eGFR slope between the rilparencel and sham cohorts (approximately 18 months after the 135th participant receives their first injection/sham) using the 2021 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) serum creatinine-based equation.
18 months after the 135th participant receives their first injection / sham.
Clinical Endpoint
Time Frame: From date of first injection until the date of first event: 40% reduction in eGFR, eGFR < 15 mL/min/1.73m² and/or chronic dialysis, and or renal transplant or date of renal or cardiovascular death, whichever came first, assessed up to 94 months.

The time from first injection to the earliest of:

  • At least 40% reduction in eGFR, sustained for 30 days, OR
  • eGFR <15 mL/min/1.73m² with corresponding two-sided 95% CI, sustained for 30 days and/or chronic dialysis, and/or kidney transplant OR
  • Renal or cardiovascular death
From date of first injection until the date of first event: 40% reduction in eGFR, eGFR < 15 mL/min/1.73m² and/or chronic dialysis, and or renal transplant or date of renal or cardiovascular death, whichever came first, assessed up to 94 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Endpoint: Time from first injection to at least a 40% reduction in eGFR sustained for 30 days.
Time Frame: From date of first injection until the date of 40% reduction in eGFR assessed up to 94 months.
• Time from first injection to at least a 40% reduction in eGFR sustained for 30 days.
From date of first injection until the date of 40% reduction in eGFR assessed up to 94 months.
Secondary Endpoint: Time from first injection to eGFR < 15 mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or kidney transplant.
Time Frame: From date of first injection until the date of eGFR < 15 mL/min/1.73m² assessed up to 94 months.
• Time from first injection to eGFR < 15 mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or kidney transplant.
From date of first injection until the date of eGFR < 15 mL/min/1.73m² assessed up to 94 months.
Secondary Endpoint: All-cause mortality.
Time Frame: From date of first injection to all-cause mortality assessed up to 94 months.
The time from first injection to all-cause mortality.
From date of first injection to all-cause mortality assessed up to 94 months.
Secondary Endpoint: Kidney Disease Quality of Life Changes
Time Frame: Week 52

• Changes from Baseline in patient-reported outcome from the Burden of Kidney Disease domain at Week 52 from the Kidney Disease Quality of Life (KDQOL) Questionnaire.

The survey is used to assess the burden, symptoms/problems, and effects of kidney disease on a patient's quality of life.
Week 52
Secondary Endpoint: Quality of Life
Time Frame: Week 52

Changes from Baseline in patient-reported outcome EuroQol 5-Dimension 5-Level (EQ5D-5L) at Week 52.

The descriptive system is divided into 5 levels of perceived problems with level 1 (indicating no problem) and level 5 (indicating extreme problems).
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prokidney

Collaborators

PPD
IQVIA Pty Ltd

Investigators

  • Study Director: Study Director, Prokidney

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

January 5, 2022

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REGEN-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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