Recruiting

REACT

Sponsor:

Prokidney

Code:

NCT05918523

Conditions

Diabetic Kidney Disease

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Renal Autologous Cell Therapy (REACT)

Study Details

Brief 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).

Conditions

Diabetic Kidney Disease

Chronic Kidney Diseases

Study ID

NCT05918523

Start date

Dec 11, 2023

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

CKD patients previously treated with REACT

Participants Exposed to Renal Autologous Cell Therapy from studies RMCL-002, REGEN-003, REGEN-004 (REGEN-008S1).

Interventions

Renal Autologous Cell Therapy (REACT)

No interventions in this trial

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Beth Hilburger

336-999-7031info@prokidney.com

Locations

Boise Kidney & Hypertension Institute

Recruiting

Meridian, Idaho, United States, 83642

Principal Investigator:

Arnold Silva, MD

More Information

Sponsor

Prokidney

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • REACT
  • DKD
  • CKD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Prokidney on 2026-09-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.