Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05918523

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boise Kidney & Hypertension Institute

Meridian, Idaho, 83642, United States

Location status: Recruiting

Location contact

Arnold Silva, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Renal Autologous Cell Therapy (REACT)

Biological

No interventions in this trial

Primary outcomes

  1. Primary Endpoint: Long-term safety of REACT

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 60 months from completion of parent protocol EOS Visit

    Time from first injection to chronic dialysis.

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

    Time frame: 60 months from completion of parent protocol EOS Visit

    Time from first injection to renal transplant.

Study contacts

Contact information is provided by the study sponsor or research team.

Beth Hilburger

CONTACT

[email protected]

336-999-7031

Sponsors and collaborators

Lead sponsor

Prokidney

Industry

Registry information

Official study title

A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies RMCL-002, REGEN-003, REGEN-004

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2023
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.