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NCT06790498

Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product

Enrolling by Invitation
Not specifiedAges 30–80Observational
Prokidney
~50 participants
Updated 2025-01-24 on ClinicalTrials.gov
What's tested:Renal Autologous Cell Therapy (REACT)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Long-term safety of REACT follow-up after completing their enrollment in the investigational clinical studies.
Measured over 60 months from completion of parent protocol EOS Visit

Conditions

Diabetic Kidney Disease
Chronic Kidney Disease

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

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

The participant must have received REACT in a previous trial (REGEN-006, REGEN- 007, and REGEN-015) for the treatment of chronic kidney disease and completed an end of study visit in their previous trial per protocol.
The participant is willing and able to cooperate with all aspects of the protocol.
The participant is willing and able to provide signed informed consent.

What this trial measures

  • Long-term safety of REACT follow-up after completing their enrollment in the investigational clinical studies.60 months from completion of parent protocol EOS Visit

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