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Cell Therapy

REACT for Chronic Kidney Disease in Diabetics

Phase 2
Waitlist Available
Research Sponsored by Prokidney
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject has a documented clinical diagnosis of an eGFR between 20 and 50 mL/min/1.73m² inclusive not requiring renal dialysis.
Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up thru month 34
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new way to inject medication into the kidneys to see if it can help improve kidney function in people with diabetes.

Who is the study for?
This trial is for men and women aged 30-80 with Type 1 or Type 2 Diabetes and Chronic Kidney Disease (CKD). Participants should have diabetic nephropathy, an eGFR of 20-50 mL/min/1.73m² without needing dialysis, controlled diabetes, and HbA1c levels below 10%. Excluded are those with renal transplants, uncontrolled blood pressure despite medication, or hemoglobin levels under 10 g/dL not improved by standard treatments.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Renal Autologous Cell Therapy (REACT), which involves up to two injections into the kidneys. It aims to see if this can slow down kidney function decline in people with either Type 1 or Type 2 Diabetes who also have CKD.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include reactions at the injection site like pain or swelling, potential infection risk from injections, allergic responses to therapy components, and unforeseen impacts on kidney function.

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.
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I have been diagnosed with type 1 or type 2 diabetes and it is under control.
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My kidney problems are due to diabetes.
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My kidney function is low but I don't need dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~thru month 34
This trial's timeline: 3 weeks for screening, Varies for treatment, and thru month 34 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute Coryza
Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 18 months after the last REACT injection.
Secondary outcome measures
Changes from Baseline in serial measurements of UACR
Changes from Baseline in serial measurements of blood urea nitrogen
Changes from Baseline in serial measurements of cystatin C
+22 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2 REACT injectionsExperimental Treatment1 Intervention
Cohort 1 subjects will receive 2 REACT injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days).
Group II: 1 REACT InjectionExperimental Treatment1 Intervention
Cohort 2 subjects will receive 1 REACT injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT injection into the contralateral 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
1,390 Total Patients Enrolled
Ashley JohnsStudy ChairProkidney
5 Previous Clinical Trials
1,299 Total Patients Enrolled

Media Library

REACT® (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05018416 — Phase 2
Chronic Kidney Disease Research Study Groups: 2 REACT injections, 1 REACT Injection
Chronic Kidney Disease Clinical Trial 2023: REACT® Highlights & Side Effects. Trial Name: NCT05018416 — Phase 2
REACT® (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05018416 — Phase 2

Frequently Asked Questions

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

Are there any vacancies available for the current clinical trial?

"Yes, according to clinicaltrials.gov this trial is actively seeking enrolment. It was first posted on the 27th of July 2021 and underwent a recent update on October 25 2022. The study requires 50 participants from 5 different sites for its completion."

Answered by AI

Could you provide information on the potential risks of Renal Autologous Cell Therapy (REACT®) for patients?

"With its Phase 2 trial, Renal Autologous Cell Therapy (REACT®) has some evidence of safety- hence the score of 2. Unfortunately, there are currently no data sets attesting to its efficacy."

Answered by AI

What is the cumulative enrollment for this trial?

"Correct. Per the clinicaltrials.gov page, this medical trial is in full swing and has been since it was first posted on July 27th 2021. The study needs to recruit 50 people from 5 clinics before its completion date of October 25th 2022."

Answered by AI

How prevalent is this trial across the city's healthcare centers?

"There are 5 recruiting sites for this scientific study, including the Boise Kidney and Hypertension Institute - Frenova in Nampa, Paragon Health, PC d/b/a Nephrology Center-Frenova in Kalamazoo, and Kidney Associates of Colorado P.C.-Frenova in Denver; two additional locations also offer enrollment opportunities."

Answered by AI

Is it possible for me to join this scientific research project?

"Applicants for this clinical trial must have type 2 diabetes mellitus, be between 30 and 80 years old, and the study is able to accept 50 individuals."

Answered by AI

Does the age requirement for this trial extend below 30 years of age?

"According to the qualifying parameters, those eligible for this trial must be over 30 years of age and no older than 80."

Answered by AI

Who else is applying?

What state do they live in?
Washington
How old are they?
18 - 65
What site did they apply to?
Boise Kidney and Hypertension Institute - Frenova
What portion of applicants met pre-screening criteria?
Met criteria
~25 spots leftby Jun 2026