A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease
• Interventions: Biological: Renal Autologous Cell Therapy (REACT); Procedure: Renal Biopsy

• Registration Number: NCT02836574
• Lead Sponsor: Prokidney

Brief Summary

To assess the safety and efficacy of up to two REACT injections given 6 months (+4 weeks) apart and delivered into the biopsied kidney using a percutaneous approach in participants with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD).

Detailed Description

Study Part 1: Multi-center, prospective, open-label, randomized, double-arm, deferred treatment study whereby eligible subjects will be randomized 1:1 after kidney biopsy to receive up to 2 injections of REACT (made from expanded autologous selected renal cells) into the biopsied kidney beginning as soon as REACT can be prepared, or the same series of up to 2 injections given 6 months (+4 weeks) apart beginning 12 months after renal biopsy. Subjects will be followed through 23 months after the last injection.

Study Part 2: An open-label extension study in which eligible subjects will be followed for an additional 36 months of long-term follow-up. Subjects will be able to roll from Study Part 2 into a Long Term Follow-Up Master protocol for up to 5 years

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-19
• Study Start: 2016-09
• Primary Completion: 2023-12
• Study Completion: 2023-12
• Disposition First Posted: 2024-02-05
• Status Verified: 2024-10
• Disposition First Submitted: 2024-10-17
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Treatment	Renal Autologous Cell Therapy (REACT)	Renal Autologous Cell Therapy (REACT) immediate treatment - Patients who are randomized to receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Immediate Treatment	Renal Biopsy	Renal Autologous Cell Therapy (REACT) immediate treatment - Patients who are randomized to receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Delayed Treatment	Renal Autologous Cell Therapy (REACT)	Renal Autologous Cell Therapy (REACT) delayed treatment - Patients who are randomized to receive standard of care treatment for the first 12 months after REACT product is made available before receiving 2 injections of REACT.
Delayed Treatment	Renal Biopsy	Renal Autologous Cell Therapy (REACT) delayed treatment - Patients who are randomized to receive standard of care treatment for the first 12 months after REACT product is made available before receiving 2 injections of REACT.

Primary Outcome Measures

Name	Time	Method
Change in Renal Function	Through 24 months following last REACT injection for active arm and at least 12 months following last REACT injection for the deferred arm	Serial measurements of estimated glomerular filtration rate (eGFR) obtained pre-randomization and at three-month intervals through 24 months after the last REACT injection in the active treatment group and at least 12 months post last REACT injection in the deferred treatment group.

Secondary Outcome Measures

Name	Time	Method
Treatment emergent adverse events	Through 24 months following last REACT injection for the active arm and at least 12 months following the last REACT injection for the deferred arm	Treatment emergent adverse events, serial safety laboratory results

Trial Locations

Locations (16)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Lehigh Valley Health Network; 🇺🇸 Allentown, Pennsylvania, United States

Renal Associates of Baton Rouge; 🇺🇸 Baton Rouge, Louisiana, United States

Mt. Sinai Hospital; 🇺🇸 New York, New York, United States

Nephrology & Hypertension Associates; 🇺🇸 Tupelo, Mississippi, United States

Paragon Health; 🇺🇸 Kalamazoo, Michigan, United States

Kidney Associates of Colorado; 🇺🇸 Denver, Colorado, United States

Yale Univeristy; 🇺🇸 New Haven, Connecticut, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Boise Kidney and Hypertension Institute; 🇺🇸 Meridian, Idaho, United States

University of North Carolina- Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States