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

Inclusion Criteria1

  • 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 Criteria1

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

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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