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Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

Primary Purpose

Chronic Kidney Diseases, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Status

Active

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 Chronic Kidney Diseases focused on measuring Kidney Biopsy, REACT

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.
Clinical diagnosis of T1DM or T2DM, controlled per institutional standard of care.
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).
The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit.
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:

The subject has a history of renal transplantation.
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.
The subject has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.

Sites / Locations

Kidney Associates of Colorado, P.C. - Frenova
Nephrology Associates
Boise Kidney and Hypertension Institute - Frenova
Paragon Health, PC d/b/a Nephrology Center, PC - Frenova
Nephrology and Hypertension Associates Ltd - Frenova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

2 REACT injections

1 REACT Injection

Arm Description

Cohort 1 subjects will receive 2 REACT injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days).

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.

Outcomes

Primary Outcome Measures

Improvement in renal function progression rate as indicated by the change from pre-injection baseline value in total (acute + chronic) slope of estimated glomerular filtration rate (eGFR) using the CKD-EPI 2009 equation

Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 18 months after the last REACT injection.

Secondary Outcome Measures

Full Information

NCT ID

NCT05018416

First Posted

August 17, 2021

Last Updated

May 2, 2023

Sponsor

Prokidney

1. Study Identification

Unique Protocol Identification Number

NCT05018416

Brief Title

Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

Official Title

A Phase 2, Randomized, Open-Labeled, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 27, 2021 (Actual)

Primary Completion Date

May 20, 2025 (Anticipated)

Study Completion Date

May 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Prokidney

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to assess the safety, efficacy, and durability of up to two REACT injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD.

Detailed Description

The objective of this study is to assess the safety, efficacy, and durability of up to two REACT injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD: Cohort 1: Two scheduled REACT injections given 3 months (+60 days) with at least 18- month follow-up Cohort 2: One scheduled REACT injection with a possible second REACT injection, no less than 3 months after the first one, within 30 days (+30 days) of meeting a renal function redose trigger (triggered up to 15 months following the first REACT injection). Both cohorts will be followed for 18 months after the final REACT injection. If a Cohort 2 subject does not meet a trigger, the subject will be followed for at least 18 months after the first injection.

6. Conditions and Keywords

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

Chronic Kidney Diseases, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Keywords

Kidney Biopsy, REACT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2 REACT injections

Arm Type

Experimental

Arm Description

Cohort 1 subjects will receive 2 REACT injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days).

Arm Title

1 REACT Injection

Arm Type

Experimental

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

Renal Autologous Cell Therapy (REACT)

Intervention Description

Autologous selected renal cells (SRC)

Primary Outcome Measure Information:

Title

Time Frame

Screening thru month 28

Title

Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 18 months after the last REACT injection.

Time Frame

Screening thru 18 months after the last injection of study drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed. Clinical diagnosis of T1DM or T2DM, controlled per institutional standard of care. 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). The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit. 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: The subject has a history of renal transplantation. 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. The subject has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ashley Johns

Organizational Affiliation

Prokidney

Official's Role

Study Director

Facility Information:

Facility Name

Kidney Associates of Colorado, P.C. - Frenova

City

Denver

State/Province

Colorado

ZIP/Postal Code

80210-5073

Country

United States

Facility Name

Nephrology Associates

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Facility Name

Boise Kidney and Hypertension Institute - Frenova

City

Nampa

State/Province

Idaho

ZIP/Postal Code

83687

Country

United States

Facility Name

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

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49007-3889

Country

United States

Facility Name

Nephrology and Hypertension Associates Ltd - Frenova

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801-6560

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

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