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Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT05099770•Prokidney

View on ClinicalTrials.gov

Summary

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.

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.

Eligibility

Age

30 - 80 years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

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.
+3 more criteria

Locations (86)

University of Arizona

Tucson, Arizona, United States

Amicis Research Center

Beverly Hills, California, United States

Paradise Clinical Research Group LLC

Glendora, California, United States

Kidney Consultants Medical Group

Granada Hills, California, United States

IMD Clinical Trials

Huntington Park, California, United States

Advanced Medical Research, LLC

Lakewood, California, United States

Medicine and Nephrology Associates

Los Alamitos, California, United States

Academic Medical Research Institute

Los Angeles, California, United States

Southern California Hospital

Los Angeles, California, United States

Allameh Medical Corporation

Mission Viejo, California, United States

Key Dates

Start Date

January 5, 2022

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2027

Last Updated

January 13, 2026

Enrollment

685

ESTIMATED participants

Conditions

Type 2 Diabetes MellitusChronic Kidney Diseases

Interventions

Renal Autologous Cell Therapy (REACT)

BIOLOGICAL

Sham Comparator

PROCEDURE

Contacts

Elizabeth Lotz

CONTACT

919-294-4521 info@prokidney.com

Catherine Taylor

CONTACT

919-294-4521 info@prokidney.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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