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A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT).

NCT ID: NCT04115345

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-13

Study Completion Date

2023-01-31

Brief Summary

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A phase 1, open-label safety, tolerability and early efficacy study of a Renal Autologous Cell Therapy (REACT) in patients with Chronic Kidney Disease from Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) (REGEN-004)

Detailed Description

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It is anticipated that all subjects will receive two planned Renal Autologous Cell Therapy (REACT) injections to allow dose-finding and evaluate the duration of effects. The scientific rationale, based on non-clinical studies, is that the biologically active component of REACT (homologous, autologous, SRC) delays progression of experimental models of Chronic Kidney Disease (CKD) by augmenting renal structure and function. As a result, the more cells that can be infused, the greater the potential improvement in renal function.

Conditions

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Chronic Kidney Disease Congenital Anomalies of Kidney and Urinary Tract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal Autologous Cell Therapy (REACT)

The volume of REACT to be administered will be determined by pre-procedure MRI volumetric 3D evaluation or ellipsoid formula. The participant will receive a second injection 6 months after the first injection into the same kidney.

Group Type EXPERIMENTAL

Renal Autologous Cell Therapy (REACT)

Intervention Type BIOLOGICAL

Autologous selected renal cells (SRC)

Interventions

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Renal Autologous Cell Therapy (REACT)

Autologous selected renal cells (SRC)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. The patient is male or female, 18 to 65 years of age on the date of informed consent.
2. The patient has a documented history of a corrected abnormality of the kidney and/or urinary tract (CAKUT) leading to renal dysfunction.
3. The patient has an established diagnosis of Stage III/IV CKD not requiring renal dialysis.
4. The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s).

Exclusion Criteria

1. The patient has a history of renal transplantation.
2. The patient has a diagnosis of hydronephrosis, SFU Grade 4 or 5.
3. The patient has an uncorrected VUR Grade 5.
4. The patient has a diffuse cortical thickness throughout the kidney measuring \< 5 mm on MRI that prevents safe cortical biopsy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CTI Clinical Trial and Consulting Services

OTHER

Sponsor Role collaborator

Prokidney

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Prokidney

Locations

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Emory University Hospital

Atlanta, Georgia, United States

Site Status

Boise Kidney & Hypertension Institute

Meridian, Idaho, United States

Site Status

Hackensack Meridian Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Site Status

Mt. Sinai Hospital

New York, New York, United States

Site Status

University of North Carolina- Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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Stavas J, Diaz-Gonzalez de Ferris M, Johns A, Jain D, Bertram T. Protocol and Baseline Data on Renal Autologous Cell Therapy Injection in Adults with Chronic Kidney Disease Secondary to Congenital Anomalies of the Kidney and Urinary Tract. Blood Purif. 2021;50(4-5):678-683. doi: 10.1159/000512586. Epub 2021 Mar 1.

Reference Type DERIVED
PMID: 33647913 (View on PubMed)

Other Identifiers

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REGEN-004

Identifier Type: -

Identifier Source: org_study_id