Clinical Trial: A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Subjects with Type 2 Diabetes and Chronic Kidney Disease (REGEN-006)

Enrollment Criteria

• Male or female 30 to 80 years of age on the date of informed consent.
• Documented diagnosis of type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) as the underlying cause of kidney disease (diagnosis does not have to be confirmed by renal biopsy).
• Serum glycosylated hemoglobin (HbA1c) of 9.5% or lower.
• An eGFR of at least 20 to < 30 mL/min/1.73m2, not requiring renal dialysis. The urinary albumin-to-creatinine ratio (UACR) level cannot exceed 5000 mg/g or an eGFR of 30 to ≤ 35 mL/min/1.73m2 and UACR of 300 to ≤ 5000 mg/g. 

Sponsor: ProKidney

Institution: University of Florida | Division of Nephrology
PI: Dr. Mark Segal, MD, PhD

Contact for Enrollment
Nicole Davila Torres, BS, Clinical Research Coordinator I
nephclinialtrial@medicine.ufl.edu | 352-273-5661

Clinical Trial: Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients with Chronic Kidney Disease (CKD) 

ClinicalTrials.gov Identifier: NCT06752577

Brief Summary: The purpose of this treatment protocol is to treat an intermediate-sized population with chronic kidney disease (CKD). Protocol includes a single treatment with intravenously-delivered allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) infusion. Individuals will have subsequent follow up for safety evaluations.

Treatment: Allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs)

Locations:
Mayo Clinic Florida, Jacksonville, Florida, United States, 32224

Principal Investigator: LaTonya Hickson MD

Contacts:
Donna Lawson 507-255-7975 Email
CT.gov

Website:  Study Details | Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients with Chronic Kidney Disease (CKD) | ClinicalTrials.gov

Name or Title of Research Study: A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Subjects with Type 2 Diabetes and Chronic Kidney Disease (REGEN-006)

Enrollment Criteria:
Male or female, 30 to 80 years of age on the date of informed consent. Has a clinical diagnosis of Type 2 Diabetes and diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy) in their health record. Serum glycosylated hemoglobin (HbA1c) less than 9.5% and an eGFR of 20 to 35 mL/min/1.73m², not requiring renal dialysis. Has a urinary albumin-to-creatinine ratio (UACR) less than or equal to 5,000 mg/g.

Treatment: Renal Autologous Cell Therapy (REACT) Injection v. Placebo

Sponsor: ProKidney

Location:  Mayo Clinic, Jacksonville, Florida, United States, 32224

Site Principal Investigator: Dr. LaTonya Hickson

Contact:  Trinity Hooks, Coordinator Email

Enrollment Criteria
Male or female, 30 to 80 years of age on the date of informed consent. Has a clinical diagnosis of Type 2 Diabetes and diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy) in their health record. Serum glycosylated hemoglobin (HbA1c) less than 10% and an eGFR greater than or equal to 20 and less than or equal to 50 mL/min/1.73m², not requiring renal dialysis. Has a urinary albumin-to-creatinine ratio (UACR) of greater than or equal to 300 and less than or equal to 5,000 mg/g.

Treatment: Renal Autologous Cell Therapy (REACT) Injection v. Placebo\

Sponsor: ProKidney

Institution: University of Florida Nephrology
PI: Dr. Mark Segal
Contact for Enrollment
Nicole Davila Torres, BS, Coordinator I
Nicole.davilatorres@medicine.ufl.edu | 352-273-5647

Name or Title of Research Study

Randomized parallel group double-blind placebo-controlled clinical trial of EMPAgliflozin once daily in patients with chronic KIDNEY disease

Enrollment Criteria: Male or female, 18+ years of age and has type 2 diabetes mellitus (T2DM) and pre-existing chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) between 20 and 90 mL/min/1.73m2 

Treatment: Empagliflozin v. Placebo

Institution: UF Nephrology

Contact for Enrollment
Sherry Brown, BSN, RN, Clinical Trials Manager
sherry.brown@medicine.ufl.edu | 352-273-5661