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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05918523
• Other study ID #: REGEN-008S1
• Status: Recruiting
• Start date: December 11, 2023
• Est. completion date: March 2028

Study information

• Verified date: February 2024
• Source: Prokidney
• Contact: Beth Hilburger
• Phone: 336-999-7031
• Email: info[@]prokidney.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Boise Kidney & Hypertension Institute	Meridian	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
Prokidney

Country where clinical trial is conducted

United States, 

Outcome

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