Trials / Completed
CompletedNCT02836574
A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
A Phase 2 Prospective, Randomized, Double-Arm, Deferred Treatment, Open Label, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 83 (actual)
- Sponsor
- Prokidney · Industry
- Sex
- All
- Age
- 30 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Renal Autologous Cell Therapy (REACT) | Autologous selected renal cells (SRC). |
| PROCEDURE | Renal Biopsy | a procedure in which a small sample of kidney tissue is removed |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2023-12-01
- Completion
- 2023-12-01
- First posted
- 2016-07-19
- Last updated
- 2025-08-24
Locations
16 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02836574. Inclusion in this directory is not an endorsement.