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

Phase 1TerminatedNCT05694169

Prokidney1 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Kidney Disease CAKUT Chronic Kidney Diseases

Interventions

Renal Autologous Cell Therapy (REACT)BIOLOGICAL

Autologous selected renal cells (SRC)

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Boise kidney and Hypertension Institute

Boise, Idaho, United States

Outcomes

Primary Outcomes

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.

Time frame: through 12 months after last supplemental injection

Secondary Outcomes

First Secondary Endpoint

Percent of participants who have the same or reduced 5-year risk of end stage renal disease (ESRD)

Time frame: 12 months after the last supplemental injection

Second Secondary Endpoint

Percent of participants who have the same or reduced 2-year risk of ESRD

Time frame: 12 months after the last supplemental injection

Data from ClinicalTrials.gov

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