Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the long-term safety of up to two gelatin-hydrogel formulation REACT injections given 3 to 6 months apart and delivered percutaneously into same kidney on renal function in participants with chronic kidney disease (CKD).
This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 80 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (RMCL-002, REGEN-003, REGEN-004) will be monitored for up to five years with alternating in clinic and phone visits.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD patients previously treated with REACT | Participants Exposed to Renal Autologous Cell Therapy from studies RMCL-002, REGEN-003, REGEN-004 (REGEN-008S1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Autologous Cell Therapy (REACT) | Biological | No interventions in this trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint: Long-term safety of REACT | Evaluation of the long-term safety of REACT will be assessed via:
| 60 months from completion of parent protocol EOS Visit |
| Measure | Description | Time Frame |
|---|---|---|
| First Secondary Endpoint: Time from first injection to eGFR <15 mL/min/1.73m² | Time from first injection to eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation. | 60 months from completion of parent protocol EOS Visit |
| Second Secondary Endpoint: Time from first injection to chronic dialysis. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
patients with CKD
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beth Hilburger | Contact | 336-999-7031 | info@prokidney.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Prokidney | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boise Kidney & Hypertension Institute | Recruiting | Meridian | Idaho | 83642 | United States |
Not provided
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Research samples (serum/plasma and/or urine) will be collected, frozen, and stored for the future research. Participating participants can opt out of long-term storage of their unused specimens during the informed consent process or at any time during the study.
Time from first injection to chronic dialysis. |
| 60 months from completion of parent protocol EOS Visit |
| Third Secondary Endpoint: Time from first injection to renal transplant. | Time from first injection to renal transplant. | 60 months from completion of parent protocol EOS Visit |
| 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 |