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A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease

Primary Purpose

Type 2 Diabetes Mellitus, Chronic Kidney Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Renal Autologous Cell Therapy (REACT)

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The subject is male or female, 30 to 65 years of age on the date of informed consent.
The subject has an established diagnosis of T2DM.
The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
The subject has an established diagnosis of CKD not requiring renal dialysis, defined as having an eGFR between 14 and 20 mL/min/1.73m² inclusive at the Screening Visit and prior to REACT injection.
The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s). Note BP should not be significantly below the previously recorded stable pressure.
A minimum of 3 measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit or within the previous 24 months to define the rate of progression of CKD. The subject should have adequate, historical clinical data to provide a reasonable estimate of the rate of progression of CKD. The Medical Monitor may be consulted to ensure there is sufficient data.

Exclusion Criteria:

The subject has a history of type 1 diabetes mellitus.
The subject has a history of renal transplantation.
The subject has a serum HbA1c level greater than 10% at the Screening Visit.
The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.

Sites / Locations

University of Arizona [WITHDRAWN]
Boise Kidney & Hypertension Institute
University of North Carolina- Chapel Hill
Vanderbilt University [WITHDRAWN]

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal Autologous Cell Therapy (REACT)

Arm Description

Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.

Outcomes

Primary Outcome Measures

Procedure and/or product related adverse events

Incidence (percentage of subjects) with procedure and/or product related adverse events by System Order Class and Preferred Term

Secondary Outcome Measures

Renal specific adverse events

Incidence (percentage of subjects) with renal-specific adverse events by System Order Class and Preferred Term

Full Information

NCT ID

NCT03270956

First Posted

August 25, 2017

Last Updated

January 6, 2023

Sponsor

Prokidney

Collaborators

CTI Clinical Trial and Consulting Services

1. Study Identification

Unique Protocol Identification Number

NCT03270956

Brief Title

A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease

Official Title

A Phase II, Open-Label Safety and Tolerability Study of an Renal Autologous Cell Therapy (REACT) in Patients With Type 2 Diabetes and Chronic Kidney Disease (REGEN-003)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

April 25, 2018 (Actual)

Primary Completion Date

November 17, 2022 (Actual)

Study Completion Date

November 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Prokidney

Collaborators

CTI Clinical Trial and Consulting Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum).

Detailed Description

All subjects enrolled will receive REACT. Subjects will receive their first REACT injection as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Chronic Kidney Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

Open label

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Renal Autologous Cell Therapy (REACT)

Arm Type

Experimental

Arm Description

Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.

Intervention Type

Biological

Intervention Name(s)

Renal Autologous Cell Therapy (REACT)

Intervention Description

Autologous selected renal cells (SRC)

Primary Outcome Measure Information:

Title

Procedure and/or product related adverse events

Description

Incidence (percentage of subjects) with procedure and/or product related adverse events by System Order Class and Preferred Term

Time Frame

Through 24 months following last REACT injection

Secondary Outcome Measure Information:

Title

Renal specific adverse events

Description

Incidence (percentage of subjects) with renal-specific adverse events by System Order Class and Preferred Term

Time Frame

Through 24 months following last REACT injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The subject is male or female, 30 to 65 years of age on the date of informed consent. The subject has an established diagnosis of T2DM. The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease. The subject has an established diagnosis of CKD not requiring renal dialysis, defined as having an eGFR between 14 and 20 mL/min/1.73m² inclusive at the Screening Visit and prior to REACT injection. The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s). Note BP should not be significantly below the previously recorded stable pressure. A minimum of 3 measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit or within the previous 24 months to define the rate of progression of CKD. The subject should have adequate, historical clinical data to provide a reasonable estimate of the rate of progression of CKD. The Medical Monitor may be consulted to ensure there is sufficient data. Exclusion Criteria: The subject has a history of type 1 diabetes mellitus. The subject has a history of renal transplantation. The subject has a serum HbA1c level greater than 10% at the Screening Visit. The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator). The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ashley Johns

Organizational Affiliation

Prokidney

Official's Role

Study Director

Facility Information:

Facility Name

University of Arizona [WITHDRAWN]

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Boise Kidney & Hypertension Institute

City

Boise

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

University of North Carolina- Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Vanderbilt University [WITHDRAWN]

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease

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