Trials / Withdrawn
WithdrawnNCT05286853
A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease
A Phase 3 Randomized Controlled Study of REACT in Participants With Type 2 Diabetes and Chronic Kidney Disease (REGEN-016)
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Prokidney · Industry
- Sex
- All
- Age
- 30 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.
Detailed description
Randomized multi-center, blinded intervention, two cohort , study whereby eligible participants will be randomized 1:1, prior to kidney biopsy, to 1 of 2 cohorts. Cohort 1 participants will undergo sham procedures and be followed for 5 years post last simulated injection.. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed for 5 years post last injection of the investigational product.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Renal Autologous Cell Therapy (REACT) | Participants receiving institutional standard of care will have a kidney biopsy followed by 2 REACT injections into biopsied and non-biopsied contralateral kidneys 3 months (+30 days) apart and will be followed for 5 years (60 months) since last REACT injection. |
| PROCEDURE | Sham Comparator | Participants receiving institutional standard of care will have 2 sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The second sham procedure will occur 3 months (+30 days) after the first sham procedure. Participants will be followed for 5 years (60 months) since last sham REACT injection. |
Timeline
- Start date
- 2024-07-17
- Primary completion
- 2024-09-03
- Completion
- 2024-09-03
- First posted
- 2022-03-18
- Last updated
- 2024-09-25
Locations
3 sites across 1 country: Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05286853. Inclusion in this directory is not an endorsement.