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

NCT05694169 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: REGEN-015
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Kidney Disease; CAKUT; Chronic Kidney Diseases

Keywords

REACT; CAKUT; DKD

Outcome Measures

Primary Outcomes (1)

• Primary Endpoints is as follows:

  Procedure and investigational product-related treatment-emergent adverse events (TEAE) will be assessed via: 1. Biopsy Related SAEs 2. Injection Procedure Related SAEs 3. Investigational Product Related SAEs 4. Treatment-Emergent SAEs.

  through 12 months after last supplemental injection

Secondary Outcomes (2)

• First Secondary Endpoint

  12 months after the last supplemental injection

• Second Secondary Endpoint

  12 months after the last supplemental injection

Study Arms (1)

Renal Autologous Cell Therapy (REACT)

EXPERIMENTAL

Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.

Biological: Renal Autologous Cell Therapy (REACT)

Interventions

Renal Autologous Cell Therapy (REACT) BIOLOGICAL

Autologous selected renal cells (SRC)

Renal Autologous Cell Therapy (REACT)

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant has received REACT in a previous trial for treatment of chronic kidney disease and completed their parent protocol follow up period.
• The participant is male or female, 30 to 80 years of age on the date of informed consent.
• 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.
• The participant has stable blood pressure and is maintained on a stable antihypertensive medication regimen if treatment for hypertension is necessary.

You may not qualify if:

• The participant has a history of renal transplantation.
• The participant has received dialysis for more than 30 days.
• The participant has received any other investigational products after completion of REACT injections within 3 months of screening.
• The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than 5,000 mg/g.
• 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.

Sponsors & Collaborators

• Prokidney: lead

Study Sites (1)

Boise kidney and Hypertension Institute

Boise, Idaho, 83642, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Cakut; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Study Director

  Prokidney

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 23, 2023
• Study Start: July 11, 2023
• Primary Completion: March 19, 2024
• Study Completion: May 13, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

US (1)