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

Recruiting

• Conditions: Diabetic Kidney Disease; Chronic Kidney Diseases
• Interventions: Biological: Renal Autologous Cell Therapy (REACT)

• Registration Number: NCT05918523
• Lead Sponsor: Prokidney

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-26
• Study Start: 2023-12-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-05
• Primary Completion: 2028-01
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CKD patients previously treated with REACT	Renal Autologous Cell Therapy (REACT)	Participants Exposed to Renal Autologous Cell Therapy from studies RMCL-002, REGEN-003, REGEN-004 (REGEN-008S1).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Boise Kidney & Hypertension Institute; 🇺🇸 Meridian, Idaho, United States