NCT05018416CompletedPhase 2
Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)
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)
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 53 (actual)
- First submitted
- 17 Aug 2021
- Start date
- 27 Jul 2021
- Primary completion date
- 20 May 2025
- Lead sponsor
- Prokidney
- NCT number
- NCT05018416
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 53
- From 27 Jul 2021 to the primary completion date, 20 May 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- The subject has a history of renal transplantation.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 30 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kidney Associates of Colorado, P.C. - Frenova Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Paragon Health, PC d/b/a Nephrology Center, PC - Frenova Coordinator of this site? Confirm its status | Kalamazoo | United States | Unknown status |
| Boise Kidney and Hypertension Institute - Frenova Coordinator of this site? Confirm its status | Nampa | United States | Unknown status |
| Nephrology Associates Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Nephrology and Hypertension Associates Ltd - Frenova Coordinator of this site? Confirm its status | Tupelo | United States | Unknown status |
Related publications
- A Randomized Clinical Trial of Kidney Autologous Cell Therapy in Diabetic Kidney Disease.Clin J Am Soc Nephrol · 2026 · PMID 41481370
This page is information, not medical advice. Discuss any trial with your doctor.