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Type 2 Diabetes MellitusPhase 2NCT02836574

A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease

A Phase 2 study testing Renal Autologous Cell Therapy (REACT) and Renal Biopsy in people with Type 2 Diabetes Mellitus and Chronic Kidney Disease, run by Prokidney at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the safety and efficacy of up to two REACT injections given 6 months (+4 weeks) apart and delivered into the biopsied kidney using a percutaneous approach in participants with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD). Read more about this study

Who is it for?
Ages 30 to 80 years
What is being tested?
Renal Autologous Cell Therapy (REACT) and Renal Biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
16 sitesUnited States
Study dates
Sep 2016to Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject is male or female, 30 to 80 years of age on the date of informed consent.
  • The subject has an established diagnosis of Type 2 Diabetes Mellitus.
  • The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
  • The subject has an established diagnosis of Chronic Kidney Disease not requiring renal dialysis, defined as having an Estimated Glomerular Filtration Rate (eGFR) between 20 and 50 mL/min/1.73m².
  • The subject has blood pressure less than 150/90 at the Screening Visit.
  • The subject has stable blood pressure and is maintained on a stable anti-hypertensive medication regimen.
Show all 9Show fewer
  • A minimum of 2 measurements of Estimated Glomerular Filtration Rate (eGFR) or serum creatine ratio (sCr) should be obtained at least 3 months apart prior to the Screening Visit or within the previous 18 months to define the rate of progression of Chronic Kidney Disease (CKD).
  • The subject is willing and able to provide signed informed consent.
  • The subject was enrolled into Part 1 of the study and received at least one Renal Autologous Cell Therapy (REACT) injection.

Who cannot join

  • The subject has a history of type 1 diabetes mellitus.
  • The subject has a history of renal transplantation.
  • The subject has a serum Hemoglobin A1c (HbA1c) level greater than 10% at the Screening Visit.
  • The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
  • The subject has hemoglobin levels less than 9 g/dL prior to each Renal Autologous Cell Therapy (REACT) injection.
  • 1. The subject is currently receiving renal dialysis.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Renal Associates of Baton Rouge

    Baton Rouge, Louisiana, 70808

  • University of North Carolina- Chapel Hill

    Chapel Hill, North Carolina, 27599

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Kidney Associates of Colorado

    Denver, Colorado, 80210

  • University of Florida

    Gainesville, Florida, 32610

  • Paragon Health

    Kalamazoo, Michigan, 49007

  • University of Louisville

    Louisville, Kentucky, 40202

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53705

  • Boise Kidney and Hypertension Institute

    Meridian, Idaho, 83642

  • Vanderbilt University

    Nashville, Tennessee, 37212

  • Yale Univeristy

    New Haven, Connecticut, 06520

  • Mt. Sinai Hospital

    New York, New York, 45246

  • University of Arizona

    Tucson, Arizona, 85724

  • Nephrology & Hypertension Associates

    Tupelo, Mississippi, 38801

Other trials in United States

About this study

Official title: A Phase 2 Prospective, Randomized, Double-Arm, Deferred Treatment, Open Label, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease

To assess the safety and efficacy of up to two REACT injections given 6 months (+4 weeks) apart and delivered into the biopsied kidney using a percutaneous approach in participants with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD).

Read the detailed description

Study Part 1: Multi-center, prospective, open-label, randomized, double-arm, deferred treatment study whereby eligible subjects will be randomized 1:1 after kidney biopsy to receive up to 2 injections of REACT (made from expanded autologous selected renal cells) into the biopsied kidney beginning as soon as REACT can be prepared, or the same series of up to 2 injections given 6 months (+4 weeks) apart beginning 12 months after renal biopsy. Subjects will be followed through 23 months after the last injection.

Study Part 2: An open-label extension study in which eligible subjects will be followed for an additional 36 months of long-term follow-up. Subjects will be able to roll from Study Part 2 into a Long Term Follow-Up Master protocol for up to 5 years

Being tested
Renal Autologous Cell Therapy (REACT), Renal Biopsy
Keywords
Rilparencel
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Renal Autologous Cell Therapy (REACT)Biological

    Also called Rilparencel

    Autologous selected renal cells (SRC).

  • Renal BiopsyProcedure or surgery

    Also called Kidney Biopsy

    a procedure in which a small sample of kidney tissue is removed

Study groups in NCT02836574
Study groupRoleWhat they receive
Active TreatmentExperimentalRenal Autologous Cell Therapy (REACT) immediate treatment - Patients who are randomized to receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Receives: Biological: Renal Autologous Cell Therapy (REACT); Procedure: Renal Biopsy
Deferred TreatmentActive comparatorRenal Autologous Cell Therapy (REACT) delayed treatment - Patients who are randomized to receive standard of care treatment for the first 12 months after REACT product is made available before receiving 2 injections of REACT.
Receives: Biological: Renal Autologous Cell Therapy (REACT); Procedure: Renal Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Renal Function

    Serial measurements of estimated glomerular filtration rate (eGFR) obtained pre-randomization and at three-month intervals through 24 months after the last REACT injection in the active treatment group and at least 12 months post last REACT injection in the deferred treatment group.

    Measured: Through 24 months following last REACT injection for active arm and at least 12 months following last REACT injection for the deferred arm

Secondary outcomes (1)

  1. Treatment emergent adverse events

    Treatment emergent adverse events, serial safety laboratory results

    Measured: Through 24 months following last REACT injection for the active arm and at least 12 months following the last REACT injection for the deferred arm

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionDec 2023
  4. Study completionDec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02836574
Sponsor's protocol ID
RMCL-002
Status last verified
Oct 2024
First submitted
22 Jun 2016
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Stavas J, Gerber D, Coca SG, Silva AL, Johns A, Jain D, Bertram T, Diaz-Gonzalez de Ferris M, Bakris G. Novel Renal Autologous Cell Therapy for Type 2 Diabetes Mellitus Chronic Diabetic Kidney Disease: Clinical Trial Design. Am J Nephrol. 2022;53(1):50-58. doi: 10.1159/000520231. Epub 2022 Jan 14.

    PubMed 35034024

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Renal Autologous Cell Therapy (REACT) and Renal Biopsy in people with Type 2 Diabetes Mellitus and Chronic Kidney Disease, run by Prokidney at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Renal Function (time frame: Through 24 months following last REACT injection for active arm and at least 12 months following last REACT injection for the deferred arm). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02836574, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.

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