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

NCT05918523 | Recruiting DMC FDA Drug

• 1 other identifier: REGEN-008S1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

REACT; DKD; CKD

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint: Long-term safety of REACT

  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.

  60 months from completion of parent protocol EOS Visit

Secondary Outcomes (3)

• First Secondary Endpoint: Time from first injection to eGFR <15 mL/min/1.73m²

  60 months from completion of parent protocol EOS Visit

• Second Secondary Endpoint: Time from first injection to chronic dialysis.

  60 months from completion of parent protocol EOS Visit

• Third Secondary Endpoint: Time from first injection to renal transplant.

  60 months from completion of parent protocol EOS Visit

Study Arms (1)

CKD patients previously treated with REACT

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

Biological: Renal Autologous Cell Therapy (REACT)

Interventions

Renal Autologous Cell Therapy (REACT) BIOLOGICAL

No interventions in this trial

CKD patients previously treated with REACT

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with CKD

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Prokidney: lead

Study Sites (1)

Boise Kidney & Hypertension Institute

Meridian, Idaho, 83642, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Research samples (serum/plasma and/or urine) will be collected, frozen, and stored for the future research. Participating participants can opt out of long-term storage of their unused specimens during the informed consent process or at any time during the study.

MeSH Terms

Conditions

Diabetic Nephropathies; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director

  Prokidney

  STUDY DIRECTOR

Central Study Contacts

Beth Hilburger

CONTACT

336-999-7031; info@prokidney.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: December 11, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

US (1)