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Long-Term Safety of REACT for Diabetic and Chronic Kidney Disease

This study is looking at the long-term safety of Renal Autologous Cell Therapy (REACT) in people with chronic kidney disease (CKD), including those with diabetic kidney disease. REACT is a treatment that involves two injections given into the kidney. You can join this study if you are between 30 and 80 years old and have already received REACT in a previous study (RMCL-002, REGEN-003, or REGEN-004). The main goal is to see how safe REACT is up to five years after your last treatment in the previous study. The study is currently unclear on its recruitment status.

Study design
This is an observational study involving up to 80 participants. It is a multi-center study, meaning it takes place at several locations.
What's involved
You will be monitored for up to five years with alternating in-clinic and phone visits.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 60 months (5 years) from the completion of their parent study's end-of-study visit.

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NCT05918523

A Long-Term Follow-Up Study of Participants Exposed to REACT

Recruiting
Not specifiedAges 30–80Observational
Prokidney
~80 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:Renal Autologous Cell Therapy (REACT)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Endpoint: Long-term safety of REACT
Measured over 60 months from completion of parent protocol EOS Visit

Conditions

Diabetic Kidney Disease
Chronic Kidney Diseases

Explore related trials

Chronic Kidney DiseaseDiabetic Nephropathy

Where it's being run

1 sites across 1 states
Idaho1

Study leadership

  • Study Director · STUDY_DIRECTOR · Prokidney

Who to contact

Beth Hilburger
[email protected]
336-999-7031
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

The participant must have received gelatin-hydrogel formulation REACT in a previous trial (RMCL-002, REGEN-003, REGEN-004) for the treatment of chronic kidney disease and completed an end of study visit in their parent trial per protocol.

Exclusion

The participant did not receive REACT in a previous trial for the treatment of chronic kidney disease.

What this trial measures

  • Primary Endpoint: Long-term safety of REACT60 months from completion of parent protocol EOS Visit

    Evaluation of the long-term safety of REACT will be assessed via: 1. Incidence of delayed serious adverse events (SAEs) obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. 2. Incidence of delayed biopsy-related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. 3. Incidence of delayed injection procedure related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. 4. Incidence of delayed investigational product related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.