A Study of Participants With Chronic Kidney Disease Previously Treated With REACT
Stopped early · Phase 1
Conditions studied: Diabetic Kidney Disease, CAKUT, Chronic Kidney Diseases
In brief
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.
Key facts
- Study ID
- NCT05694169
- Run by
- Prokidney
- People needed
- 1
- Starts
- 2023-07-11
- Expected to finish
- 2024-05-13
- Last updated by the study team
- 2025-02-28
Who can join
Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Boise kidney and Hypertension Institute — Boise, Idaho, United States
Full record on ClinicalTrials.gov
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