A Study of Participants With Chronic Kidney Disease Previously Treated With REACT

Chronic Kidney Diseases Clinical Trial

Official title:

A Phase 1, Open-label, Supplemental Dosing Study of Participants With Chronic Kidney Disease Previously Treated With REACT (REGEN-015)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05694169
• Other study ID #: REGEN-015
• Status: Recruiting
• Phase: Phase 1
• Start date: July 11, 2023
• Est. completion date: June 2025

Study information

• Verified date: August 2023
• Source: Prokidney
• Contact: Julie Lopez
• Phone: +1 919 788 3124
• Email: julie.lopez[@]iconplc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment.

Description:

A Phase 1, Open-label trial where up to 10 participants will enroll in the trial after parent REACT protocol EOS visit completion. Participants may undergo a biopsy to manufacture REACT if additional biopsy tissue is required. Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The participant has received REACT in a previous trial for treatment of chronic kidney disease and completed their parent protocol follow up period.

2. The participant is male or female, 30 to 80 years of age on the date of informed consent.

3. The participant has a documented clinical diagnosis of an eGFR greater than or equal to 14 and less than or equal to 50 mL/min/1.73m2, not requiring renal dialysis.

4. The participant has stable blood pressure and is maintained on a stable antihypertensive medication regimen if treatment for hypertension is necessary.

Exclusion Criteria:

1. The participant has a history of renal transplantation.

2. The participant has received dialysis for more than 30 days.

3. The participant has received any other investigational products after completion of REACT injections within 3 months of screening.

4. The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than 5,000 mg/g.

5. The participant has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to screening.

Related Conditions & MeSH terms

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

Intervention

Biological:
• Renal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC)

Locations

Country	Name	City	State
United States	Boise kidney and Hypertension Institute	Boise	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 Endpoints is as follows:	Procedure and investigational product-related treatment-emergent adverse events (TEAE) will be assessed via: Biopsy Related SAEs; Injection Procedure Related SAEs; Investigational Product Related SAEs; Treatment-Emergent SAEs.	through 12 months after last supplemental injection
Secondary	First Secondary Endpoint	Percent of participants who have the same or reduced 5-year risk of end stage renal disease (ESRD)	12 months after the last supplemental injection
Secondary	Second Secondary Endpoint	Percent of participants who have the same or reduced 2-year risk of ESRD	12 months after the last supplemental injection