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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05918523

Enrollment

Registered

2023-06-26

Start date

2023-12-11

Completion date

2028-03-01

Last updated

2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Diabetic Kidney Disease

Keywords

REACT, DKD, CKD

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).

Detailed description

This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 80 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (RMCL-002, REGEN-003, REGEN-004) will be monitored for up to five years with alternating in clinic and phone visits.

Interventions

BIOLOGICALRenal Autologous Cell Therapy (REACT)

No interventions in this trial

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
First Secondary Endpoint: Time from first injection to eGFR <15 mL/min/1.73m²	60 months from completion of parent protocol EOS Visit	Time from first injection to eGFR \<15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation.
Second Secondary Endpoint: Time from first injection to chronic dialysis.	60 months from completion of parent protocol EOS Visit	Time from first injection to chronic dialysis.
Third Secondary Endpoint: Time from first injection to renal transplant.	60 months from completion of parent protocol EOS Visit	Time from first injection to renal transplant.

Countries

United States

Contacts

CONTACTBeth Hilburger

info@prokidney.com336-999-7031

STUDY_DIRECTORStudy Director

Prokidney

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026