Patients who meet certain criteria volunteer to participate in carefully conducted investigations that discover better ways to treat, prevent, diagnose, and understand human disease – including Chronic Kidney Disease. Here at Frenova Baton Rouge, we specialize in Renal research.
Our team is focused on supporting our research patients while advancing renal care. All research studies are approved by the FDA and are continuously monitored by the IRB - a group unconnected to the research team that reviews each study to ensure patient rights, safety standards and protocol. Not only do participants help us improve and advance kidney treatment, they often become more knowledgeable and engaged in their own kidney care.
Frenova, part of Fresenius Medical Care North America (FMCNA), is a team of renal research experts that operate at the convergence of clinical research and renal patient care. No other clinical development services provider works with a more intimate understanding of patients affected by kidney disease and its comorbid conditions than we do. Frenova provides access to the largest renal research site network in the world.
Our Baton Rouge site is led by Principal Investigator Dr. Michael Roppolo, who explains that “By allowing Frenova to direct the clinical research staff and trial operations, we can enroll more patients into studies and ultimately help patients by introducing new advances and treatments to the market.”
Frenova Baton Rouge is a member of the Frenova F1RST Up alliance, a highly select group of sites chosen for their expertise in renal research and track record of rapid patient recruitment and retention.
Since Frenova has partnered with Renal Associates, we have tripled in size, in staff and research studies that are offered. We look forward to benefitting our patients in the years to come!
Humacyte V007 – Vascular Access NCT03183245
A phase 3 study to compare the efficacy and safety of Humacyte’s Human Acellular Vessel with that of an autologous arteriovenous fistula in subjects with end-stage renal disease receiving dialysis via dialysis catheter.
Sanifit 06 – Calciphylaxis: NCT04195906
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SNF472 When Added to Background Care for the Treatment of Calciphylaxis in dialysis patients.
FibroGen DENALI – Anemia: NCT 04410198
This is a phase 3b multicenter, open-label single arm study of oral Roxadustat in Dialysis patients with anemia. Patients can either convert from ESA therapy or can be ESA-naive.
inRegen RMCL-002 Neo-Kidney Augment (NKA) – Type 2 Diabetes: NCT02836574
Multi-center, prospective, open label, randomized, double-arm, deferred treatment study where by eligible subjects will be randomized 1:1 after a kidney biopsy to receive up to 2 injections of NKA (made from expanded autologous selected renal cells) into the biopsied kidney beginning as soon as NKA can be prepared, or the same series of up to 2 injections given 6 months (+4 weeks) apart beginning 12 months after renal biopsy.
Vertex VX19-147-101 – FSGS: NCT04340362
Phase 2, open-label, single-arm study to evaluate the ability of oral VX-147 to reduce proteinuria via modulation of the APOL1 pathway in patients with APOL1 mediated FSGS. Genotyping provided by sponsor.
Vertex VX19-NEN-801 – APOL1 - FSGS
Genetic study of the prevalence of APOL1 alleles in adults with FSGS who are of recent African ancestry or geographic origin. No study drug will be administered. A blood sample will be collected.
inRegen RMCL-004 (Neo-Kidney Augment) – Chronic Kidney Disease from Congenital Anomalies of the Kidney and Urinary Tract (CAKUT): NCT 04115345
Multi-center, prospective, open-label, single-group study. All subjects will be treated with two NKA injections 6 months (+4 weeks) apart after biopsy.
Reata 402-C-1808 – Bardoxolone methyl – ADPKD: NTC03918447
A Phase 3 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients with ADPKD who are not on Tolvaptan
GSK 200808 – Anemia: NCT02876835
A Phase 3, Randomized, open-label (sponsor-blind), active controlled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.