| Chronic Kidney Disease | Name 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.
- 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.
Treatment: Renal Autologous Cell Therapy (REACT) Injection v. Placebo
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 | | | Uremic pruritis ( itching) in ckd | Name or Title of Research Study Uremic pruritis ( itching) in ckd | Link to Trial Information https://clinicaltrials.gov/study/NCT05978063?cond=difelikefalin&rank=6 | Institution
CFLKS and NCCF.r
Contact for Enrollment
Arvind Madan, MD
amadan@cflks.com
(407) 230-5269
Cflks.com | | | Type 2 Diabetes and Chronic Kidney Disease
| 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 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
|
APOL1-mediated Proteinuric Kidney Disease
| Title of Research Study: A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 12 Years and Older with APOL1-mediated Proteinuric Kidney Disease (Vertex)
| Enrollment Criteria
Male or female who is between 12 and 65 years of age, has an APOL1 genotype of G1/G1, G2/G2, or G1/G2, and has Proteinuric kidney disease.
| Treatment: VX-147 v. Placebo
Sponsor: Vertex Pharmaceuticals
| Institution: University of Florida Nephrology PI: Dr. Wai Lang Lau Contact for Enrollment
Nicole Davila Torres, BS, Coordinator I
Nicole.davilatorres@medicine.ufl.edu | 352-273-5647
| | |
MCD, IgA, FSGS, MN
| Title of Research Study: NEPTUNE: The Nephrotic Syndrome Study Network
| | PI: Dr. Fornoni, Dr.Contreras, Dr. Lenz | | Sponsor: NIH-Office of Rare Kidney Disease-NIDDK, DHHS-NephCure Kidney International, The University of Michigan | | Active/Enrolled/InScreening: 4/51/1 | Institution: UM Nephrology
Contact for Enrollment:
Jacqueline Vassallo, CCRP.
jvassall@med.miami.edu
Tel: 305-243-4691 |
MCD, IgA, FSGS, MN
| Title of Research Study: CureGN: Cure Glomerulonephropathy Network
| | PI: Dr. Fornoni, Dr.Contreras, Dr. Lenz | | Sponsor: NIH-NIDDK-NephCure Kidney International | | Active/Enrolled/InScreening: 7/10/0 | Institution: UM Nephrology
Contact for Enrollment:
Jacqueline Vassallo, CCRP.
jvassall@med.miami.edu
Tel: 305-243-4691 |
|
Florida Women in Nephrology Chair
FSN President
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