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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).
The objective 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):
Both cohorts will be followed for 18 months after the final REACT/ rilparencel injection. If a Cohort 2 subject does not meet a trigger, the subject will be followed for at least 18 months after the first injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 Renal Autologous Cell Therapy (REACT)/ rilparencel injections | Experimental | Cohort 1 subjects will receive 2 REACT/ rilparencel injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days). |
|
| 1 Renal Autologous Cell Therapy (REACT)/ rilparencel Injection | Experimental | Cohort 2 subjects will receive 1 REACT / rilparencel injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT/ rilparencel injection into the contralateral kidney. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Autologous Cell Therapy (REACT) | Biological | Autologous selected renal cells (SRC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in renal function progression rate as indicated by the change from pre-injection baseline value in total (acute + chronic) slope of estimated glomerular filtration rate (eGFR) using the CKD-EPI 2009 equation | Screening thru month 28 | |
| Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 18 months after the last REACT injection. | Screening thru 18 months after the last injection of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Taylor | Prokidney | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kidney Associates of Colorado, P.C. - Frenova | Denver | Colorado | 80210-5073 | United States | ||
| Nephrology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41481370 | Derived | Cizman B, Butler EL, Stavas J, Prakash R, Saad T, Silva A, Wooldridge T, Aqeel A, Yan H, Barysauskas CM, Culleton B. A Randomized Clinical Trial of Kidney Autologous Cell Therapy in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Jan 2;21(5):744-53. doi: 10.2215/CJN.0000000969. Online ahead of print. |
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|
| Newark |
| Delaware |
| 19713 |
| United States |
| Boise Kidney and Hypertension Institute - Frenova | Nampa | Idaho | 83687 | United States |
| Paragon Health, PC d/b/a Nephrology Center, PC - Frenova | Kalamazoo | Michigan | 49007-3889 | United States |
| Nephrology and Hypertension Associates Ltd - Frenova | Tupelo | Mississippi | 38801-6560 | United States |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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