Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the USA / NCT06790498
Enrolling by invitation Observational

Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product

NCT06790498 · tracked via the Priya Life Science USA tracker
Sponsor
Prokidney
Phase
Observational
Started
2023-11-23
Last updated
2026-09-17

Condition(s) studied

Diabetic Kidney DiseaseChronic Kidney Disease

Investigational drug(s) / intervention(s)

Renal Autologous Cell Therapy (REACT)

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

Study summary

The purpose of this study is to evaluate the long-term safety, efficacy, and durability in participants with chronic kidney disease (CKD) who received up to four REACT injections, delivered percutaneously into either the same or bilateral kidneys in previous studies.

Eligibility

Sex
ALL
Min age
30 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * The participant must have received REACT in a previous trial (REGEN-006, REGEN- 007, and REGEN-015) for the treatment of chronic kidney disease and completed an end of study visit in their previous trial per protocol. * The participant is willing and able to cooperate with all aspects of the protocol. * The participant is willing and able to provide signed informed consent. Exclusion Criteria: • Participant did not receive REACT in a previous trial for the treatment of chronic kidney disease

Primary outcome measure(s)

  • Long-term safety of REACT follow-up after completing their enrollment in the investigational clinical studies. — 60 months from completion of parent protocol EOS Visit
    Evaluation of the long-term safety of REACT will be assessed via: * Incidence of delayed serious adverse events (SAEs) obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. * Incidence of delayed biopsy-related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. * Incidence of delayed injection procedure related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. * 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)

FacilityCityRegionStatus
Boise Kidney & Hypertension Institute Meridian Idaho

More Prokidney trials in the USA

Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease Active, not recruiting
A Long-Term Follow-Up Study of Participants Exposed to REACT Recruiting

Other trials for the same condition

A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria Active, not recruiting
A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria Recruiting
A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease Recruiting
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis Recruiting
Renal Impairment Study for Oral EC5026 Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06790498 on ClinicalTrials.gov ↗ ← All trials in the USA