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

Phase 1

Recruiting

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

• Registration Number: NCT05694169
• Lead Sponsor: Prokidney

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-23
• Study Start: 2023-07-11
• Status Verified: 2023-08
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-21
• Primary Completion: 2025-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal Autologous Cell Therapy (REACT)	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.

Primary Outcome Measures

Name	Time	Method
Primary Endpoints is as follows:	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.

Secondary Outcome Measures

Name	Time	Method
First Secondary Endpoint	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)
Second Secondary Endpoint	12 months after the last supplemental injection	Percent of participants who have the same or reduced 2-year risk of ESRD

Trial Locations

Locations (1)

Boise kidney and Hypertension Institute; 🇺🇸 Boise, Idaho, United States