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

Condition(s) studied

Investigational drug(s) / intervention(s)

Renal Autologous Cell Therapy (REACT): No interventions in this trial

Study 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

Primary outcome measure(s)

• Primary Endpoint: Long-term safety of REACT — 60 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.

Trial sites (1)

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