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Cell Therapy

Renal Autologous Cell Therapy (REACT) for Chronic Kidney Disease

Phase 1
Waitlist Available
Research Sponsored by Prokidney
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months following last react injection
Awards & highlights

Study Summary

This trial is studying the safety and early effectiveness of a cell therapy in people with kidney disease from birth defects.

Eligible Conditions
  • Chronic Kidney Disease
  • Kidney and Urinary Tract Anomalies

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months following last react injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months following last react injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess change in eGFR and observe incidence of renal-specific procedure and/or product related adverse events (AEs) through 18 months following two Renal Autologous Cell Therapy (REACT) injections [Safety].
Secondary outcome measures
Number of subjects with renal-specific adverse events over a 18-month period following injection of Renal Autologous Cell Therapy (REACT).

Trial Design

1Treatment groups
Experimental Treatment
Group I: Renal Autologous Cell Therapy (REACT)Experimental Treatment1 Intervention
The volume of REACT to be administered will be determined by pre-procedure MRI volumetric 3D evaluation or ellipsoid formula. The participant will receive a second injection 6 months after the first injection into the same kidney.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Renal Autologous Cell Therapy (REACT)
2016
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

ProkidneyLead Sponsor
8 Previous Clinical Trials
1,437 Total Patients Enrolled
CTI Clinical Trial and Consulting ServicesOTHER
34 Previous Clinical Trials
3,729 Total Patients Enrolled
Study DirectorStudy DirectorProkidney
1,221 Previous Clinical Trials
499,968 Total Patients Enrolled
~1 spots leftby Jun 2025
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