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

Completed · Phase 2

Conditions studied: Chronic Kidney Diseases, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

In brief

The purpose of this study is to assess the safety, efficacy, and durability of up to two Renal Autologous Cell Therapy (REACT) / rilparencel injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with Type1 Diabetes Mellitus (T1DM) or Type2 Diabetes Mellitus(T2DM) and Chronic Kidney Disease (CKD).

Key facts

Study ID

NCT05018416

Run by

Prokidney

People needed

53

Starts

2021-07-27

Expected to finish

2025-05-20

Last updated by the study team

2026-03-13

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.
• Clinical diagnosis of Type1 Diabetes Mellitus or Type2 Diabetes Mellitus, 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.

You may not qualify if…

• 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 Chronic Kidney Disease-related anemia prior to randomization.

Where it is running

• Kidney Associates of Colorado, P.C. - Frenova — Denver, Colorado, United States
• Nephrology Associates — Newark, Delaware, United States
• Boise Kidney and Hypertension Institute - Frenova — Nampa, Idaho, United States
• Paragon Health, PC d/b/a Nephrology Center, PC - Frenova — Kalamazoo, Michigan, United States
• Nephrology and Hypertension Associates Ltd - Frenova — Tupelo, Mississippi, United States

Full record on ClinicalTrials.gov

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