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NCT05694169 | Recruiting | Diabetic Kidney Disease

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

Condition or disease

Diabetic Kidney Disease

target

Chronic Kidney Diseases

Intervention/treatment

Renal Autologous Cell Therapy (REACT)

Phase

Phase 1

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
Estimated Enrollment : 10 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : A Phase 1, Open-label, Supplemental Dosing Study of Participants With Chronic Kidney Disease Previously Treated With REACT (REGEN-015)
Actual Study Start Date : July 11, 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : June 2025
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)
Ages Eligible for Study: 30 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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.
A Study of Participants With Chronic Kidney Disease Previously Treated With REACT

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, Idaho

Boise kidney and Hypertension Institute

Boise, Idaho, United States, 83642