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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 stable blood pressure and is maintained on a stable antihypertensive medication regimen if treatment for hypertension is necessary.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 12 months after last supplemental injection
Awards & highlights

Study 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 blood pressure is stable, and if I take medication for it, the dose hasn't changed recently.
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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.

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
1,206 Previous Clinical Trials
489,644 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can Renal Autologous Cell Therapy (REACT) be considered a risk factor for individuals?

"Due to REACT being in its initial testing period, with a dearth of information on safety and efficacy, our team has assigned it the lowest score according to this scale: 1."

Answered by AI

What is the maximum size of enrollees for this particular research program?

"Affirmative. Data hosted on clinicaltrials.gov corroborates that this medical study, which was initially posted on July 11th 2023, is actively searching for patients to enrol in the trial. There are 10 positions available at a single site of investigation."

Answered by AI

Is there currently an opportunity for participants to join this research initiative?

"Per the data available on clinicaltrials.gov, this medical trial is recruiting patients; it was initially posted on July 11th and last updated August 16th of 2023."

Answered by AI

Are individuals of all ages, up to 85 years old, eligible for participation in this experiment?

"In order to meet the requirements for this clinical trial, all potential participants must be between 30 and 80 years of age. There are 46 studies specifically targeting minors and 498 trials dedicated to those over 65."

Answered by AI

Who is qualified to register for this scientific experiment?

"This medical trial is recruiting 10 individuals with diabetic kidney disease aged between 30 and 80. Eligibility requires a history of REACT treatment, no need for renal dialysis, stable blood pressure maintained by antihypertensive medication if necessary, and eGFR values within the range 14-50 mL/min/1.73m2."

Answered by AI
~5 spots leftby Mar 2025