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Could a kidney cell injection slow Diabetes-Related kidney failure?

NCT ID NCT05018416

Disease control Sponsor: Prokidney Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental cell therapy called REACT (rilparencel) in 53 adults with type 1 or 2 diabetes and chronic kidney disease. The therapy involves injecting a person's own kidney cells into their kidneys to see if it can slow the loss of kidney function. The goal is to improve safety and delay the need for dialysis or transplant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

53 people

The number who actually took part.

Started

Jul 2021

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed. 2. Clinical diagnosis of Type1 Diabetes Mellitus or Type2 Diabetes Mellitus, controlled per institutional standard of care. 3. The subject has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy). 4. The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit. 5. The subject has a documented clinical diagnosis of an eGFR between 20 and 50 mL/min/1.73m² inclusive not requiring renal dialysis. Exclusion Criteria: 1. The subject has a history of renal transplantation. 2. The subject has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening. Subjects with blood pressure outside of this range prior to biopsy/injection may continue if approved by the Medical Monitor. 3. The subject has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for Chronic Kidney Disease-related anemia prior to randomization.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome type 1 diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney diseases Type 1 diabetes mellitus Type 2 diabetes mellitus

Contacts and locations

Locations

  • Boise Kidney and Hypertension Institute - Frenova

    Nampa, Idaho, 83687, United States

  • Kidney Associates of Colorado, P.C. - Frenova

    Denver, Colorado, 80210-5073, United States

  • Nephrology Associates

    Newark, Delaware, 19713, United States

  • Nephrology and Hypertension Associates Ltd - Frenova

    Tupelo, Mississippi, 38801-6560, United States

  • Paragon Health, PC d/b/a Nephrology Center, PC - Frenova

    Kalamazoo, Michigan, 49007-3889, United States

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