RecruitingNCT05918523

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

A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies RMCL-002, REGEN-003, REGEN-004


Sponsor

Prokidney

Enrollment

80 participants

Start Date

Dec 11, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to evaluate the long-term safety of up to two gelatin-hydrogel formulation REACT injections given 3 to 6 months apart and delivered percutaneously into same kidney on renal function in participants with chronic kidney disease (CKD).


Eligibility

Min Age: 30 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This long-term follow-up study is tracking the health of people who previously received a treatment called REACT — an experimental kidney therapy made from a gelatin-hydrogel formulation — as part of an earlier clinical trial for chronic kidney disease. The goal is to monitor participants' long-term health and safety outcomes years after receiving that treatment. There are no new treatments involved; this is purely an observational follow-up to ensure the long-term safety of those who participated before. **You may be eligible if:** - You previously received the REACT treatment in one of three specific earlier clinical trials: RMCL-002, REGEN-003, or REGEN-004 - Those trials were for the treatment of chronic kidney disease - You completed the required final study visit in your original trial according to the protocol **You may NOT be eligible if:** - You did not actually receive the REACT treatment in a prior clinical trial (for example, if you were in a control group that did not receive it) - You did not complete the required end-of-study visit in your original trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRenal Autologous Cell Therapy (REACT)

No interventions in this trial


Locations(1)

Boise Kidney & Hypertension Institute

Meridian, Idaho, United States

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NCT05918523


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