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The purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment.
A Phase 1, Open-label trial where up to 10 participants will enroll in the trial after parent REACT protocol EOS visit completion. Participants may undergo a biopsy to manufacture REACT if additional biopsy tissue is required. Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Autologous Cell Therapy (REACT) | Experimental | Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Autologous Cell Therapy (REACT) | Biological | Autologous selected renal cells (SRC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoints is as follows: | Procedure and investigational product-related treatment-emergent adverse events (TEAE) will be assessed via:
| through 12 months after last supplemental injection |
| Measure | Description | Time Frame |
|---|---|---|
| First Secondary Endpoint | Percent of participants who have the same or reduced 5-year risk of end stage renal disease (ESRD) | 12 months after the last supplemental injection |
| Second Secondary Endpoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Prokidney | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boise kidney and Hypertension Institute | Boise | Idaho | 83642 | United States |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| C566906 | Cakut |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Percent of participants who have the same or reduced 2-year risk of ESRD
| 12 months after the last supplemental injection |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |