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

Part of paid clinical trials in Meridian, Idaho.

Sponsor
Prokidney
Study ID
NCT05918523
Status
Recruiting
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Conditions

  • Chronic Kidney Diseases
  • Diabetic Kidney Disease

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Renal Autologous Cell Therapy (REACT) — BIOLOGICAL
    No interventions in this trial

Study Details

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).

Key Dates

Start date
Dec 11, 2023
Status verified
May 2025
Primary completion
Jan 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: CKD patients previously treated with REACT
    Participants Exposed to Renal Autologous Cell Therapy from studies RMCL-002, REGEN-003, REGEN-004 (REGEN-008S1).

Primary Outcome Measure

Primary Endpoint: Long-term safety of REACT [ Time Frame: 60 months from completion of parent protocol EOS Visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boise Kidney & Hypertension InstituteMeridianIdaho83642
Arnold Silva, MD (PRINCIPAL_INVESTIGATOR)

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Boise Kidney & Hypertension Institute· Meridian, ID

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