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

December 19, 2023 updated by: Prokidney

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Idaho
      • Boise, Idaho, United States, 83642
        • Recruiting
        • Boise Kidney and Hypertension Institute
        • Contact:
          • Arnold Silva, MD
          • Phone Number: 208-846-8335

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal Autologous Cell Therapy (REACT)
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)
Autologous selected renal cells (SRC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Endpoints is as follows:
Time Frame: through 12 months after last supplemental injection

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Secondary Endpoint
Time Frame: 12 months after the last supplemental injection
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
Second Secondary Endpoint
Time Frame: 12 months after the last supplemental injection
Percent of participants who have the same or reduced 2-year risk of ESRD
12 months after the last supplemental injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prokidney

Investigators

  • Study Director: Study Director, Prokidney

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

December 27, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REGEN-015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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