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

Prokidney

Status and phase: Terminated; Phase 1

Conditions: Chronic Kidney Diseases; CAKUT; Diabetic Kidney Disease

Treatments: Biological: Renal Autologous Cell Therapy (REACT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05694169

REGEN-015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Renal Autologous Cell Therapy (REACT)

Experimental group

Description:

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

Treatment:

Biological: Renal Autologous Cell Therapy (REACT)