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

No Placebo-Only Group

Summary

This trial tests a new treatment that uses a patient's own kidney cells to help repair their kidneys. It targets patients with a specific type of chronic kidney disease that doesn't respond well to usual treatments. The goal is to slow down the disease and improve kidney function.

Eligible Conditions

Chronic Kidney Disease
Kidney and Urinary Tract Anomalies

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months following last react injection

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Number of subjects with renal-specific adverse events over a 18-month period following injection of Renal Autologous Cell Therapy (REACT).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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