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Cell Therapy

REACT for Chronic Kidney Disease

Phase 1
Recruiting
Research Sponsored by Prokidney
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 is male or female, 30 to 80 years of age on the date of informed consent.
Must not have
The participant has received dialysis for more than 30 days.
The participant has a history of renal transplantation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after the last supplemental injection
Awards & highlights

Summary

This trial will test if a kidney disease treatment is safe for people who have already had it. #CKD

Who is the study for?
This trial is for adults aged 30-80 with chronic kidney disease who've had REACT treatment before. They must have stable blood pressure, possibly managed by medication, and not need dialysis yet. People can't join if they've been on dialysis over 30 days, tried other new treatments recently, have very high protein in their urine, a past kidney transplant or low hemoglobin unresponsive to anemia treatment.Check my eligibility
What is being tested?
The study tests the safety of additional REACT injections in people with chronic kidney disease who previously received this therapy. It aims to see how well patients tolerate more doses of the same treatment they had earlier.See study design
What are the potential side effects?
While specific side effects are not listed here, generally such interventions could lead to injection site reactions, potential worsening of kidney function or issues related to immune response depending on individual patient conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is low but I don't need dialysis.
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I am between 30 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been on dialysis for over a month.
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I have had a kidney transplant.
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My hemoglobin is below 10 g/dL and treatments for anemia due to kidney disease haven't worked.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after the last supplemental injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after the last supplemental 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
Primary Endpoints is as follows
Secondary outcome measures
First Secondary Endpoint
Second Secondary Endpoint

Trial Design

1Treatment groups
Experimental Treatment
Group I: Renal Autologous Cell Therapy (REACT)Experimental Treatment1 Intervention
Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.
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
1,433 Total Patients Enrolled
Study DirectorStudy DirectorProkidney
1,230 Previous Clinical Trials
501,080 Total Patients Enrolled
Ashley Johns, MSHSStudy DirectorProkidney
2 Previous Clinical Trials
81 Total Patients Enrolled

Media Library

REACT (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05694169 — Phase 1
Diabetic Kidney Disease Research Study Groups: Renal Autologous Cell Therapy (REACT)
Diabetic Kidney Disease Clinical Trial 2023: REACT Highlights & Side Effects. Trial Name: NCT05694169 — Phase 1
REACT (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05694169 — Phase 1
~4 spots leftby Mar 2025
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