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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months after the last supplemental injection

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

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

Primary study objectives

Primary Endpoints is as follows

Secondary study objectives

First Secondary Endpoint

Second Secondary Endpoint

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

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

0 / 5Eligibility criteria met