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FIDES CLINICAL RESEARCH

Research Studies

Current Studies

Title
Participants Diagnosis
Descriptions
Phase
Cerium ACTH-PMN-301
PMN
Comparing the safety and efficacy of SNP-ACTH (1-39) Gel compared to Rituximab and FDA approved biosimilars in adults with primary membranous nephropathy (PMN) in a Two-Phase Adaptive Trial Design
Phase 3 Superiority Study
Chinook CHK01-03
IgAN on SGLT2i
Study of Atrasentan in subjects with IgA Nephropathy on Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i)
Randomized, Double-Blind, Placebo-Controlled, Crossover
Eli Lilly J1I-MC-GZBO
Atherosclerotic Cardiovascular Disease, Chronic Kidney Disease
Investigate the effect of retatrutide on the incidence of major adverse cardiovascular events and the decline in kidney function in participants with body mass index >= 27 kg/m^2 and atherosclerotic cardiovascular disease and/or chronic kidney disease
Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven
Novartis CVAY736K12301
SIRIUS-LN
Evaluate the efficacy, safety, and tolerability of ianalumab on top of standard-of-care therapy in participants with active lupus nephritis (SIRIUS-LN)
Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Phase 3
Otsuka 417-201-00007
IgAN
Evaluate the efficacy and safety of Sibeprenlimab administered subcutaneously in subjects with Immunoglobulin A Nephropathy
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled
Pathalys PP3002
PATH-1
Evaluating the efficacy and safety of dose-titrated PLS240 in the treatment of secondary hyperparathyroidism in individuals with end stage kidney disease on hemodialysis (PATH-1) with an open-label extension
Phase 3 Randomized, Double-Blind, Placebo-Controlled
Vertex VX21-147-301
APOL1
Evaluate the efficacy and safety of VX-147 in adult and pediatric subjects with APOL1-mediated Proteinuric Kidney Disease
Phase ⅔ Adaptive, Double-blind, Placebo-Controlled

Previous Studies

Sponsor
Description
Phase
Gilead
Evaluating the Efficacy and Safety of Selonsertib in Subjects with Moderate to Advanced Diabetic Kidney Disease
Phase 2b, Randomized, Double-Blind, Placebo- Controlled, Parallel Group, Multicenter Study
Tricida
Evaluate the Efficacy and Safety of TRC101 In Subjects with Chronic Kidney Disease and Metabolic Acidosis
Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study
Ironwood
Evaluate the Safety and Efficacy Of IW-1973 In Patients with Type 2 Diabetes with Albuminuria Treated with Renin-Angiotensin System Inhibitors
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study
Pharmacosmos A/S
Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside (Monofer) And Iron Sucrose in Subjects with Iron Deficiency Anemia and Non-Dialysis-Dependent Chronic Kidney Disease
Phase III, Randomized, Open-Label
Akebia Therapeutics
Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)
Phase 3, Randomized, Open-Label, Active-Controlled Study
Akebia Therapeutics
Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INO2VATE-CONVERSION)
Phase 3, Randomized, Open-Label, Active-Controlled Study
Akebia Therapeutics
Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD(PRO2TECT-CORRECTION)
Phase 3, Randomized, Open-Label, Active-Controlled Study
GlaxoSmithKline
Dialysis Subjects with Anemia Associated with Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Recombinant Human Erythropoietin, Following A Switch from Erythropoietin-Stimulating Agents
Phase 3 Randomized, Open-Label (Sponsor-Blind), Active-Controlled, Parallel-Group, Multi-Center, Event Driven Study
GlaxoSmithKline
Non-Dialysis Subjects with Anemia Associated with Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa
Phase 3 Randomized, Open-Label (Sponsor-Blind), Active-Controlled, Parallel-Group, Multi-Center, Event Driven Study
Bayer
Investigate the Efficacy and Safety of Finerenone, In Addition to Standard of Care, On the Progression of Kidney Disease in Subjects with Type 2 Diabetes Mellitus and The Clinical Diagnosis of Diabetic Kidney Disease
Randomized, Double-Blind, Place-Controlled, Parallel-Group, Multicenter, Event-Driven Phase III Study
Bayer
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Event-Driven Phase III Study to Investigate the Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects with Type 2 Diabetes Mellitus and The Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care
3
Astrazeneca
Evaluating the Safety and Efficacy of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
Ablynx
Evaluate the Safety and Efficacy Of ALX-0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus
Phase 2, Multicenter, Randomized, Double-Blind, Placebo Controlled, Dose-Range Finding Study
Takeda
Evaluate the Efficacy and Safety of Febuxostat 40mg XR, 80mg XR, 40mg IR and 80mg IR In Subjects with Gout
Phase 3, Randomized, Double-Blind, Multicenter, Placebo Controlled Study
Pfizer
Evaluate the Efficacy and Safety of Once-Daily Administration of a Chemokine CCR2/5 Receptor Antagonist PF-04634817In Adults with Type 2 Diabetes and Overt Nephropathy
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study
Amgen
START-CKD: Strategies Using Darbepoetin Alfa To Avoid Transfusions in Chronic Kidney Disease
N/A
Mallinckrodt
Safety and Efficacy Study Of H.P Acthar® Gel (Acthar) In Patients with Diabetic Nephropathy and Proteinuria
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adaptive Design Pilot
GlaxoSmithKline
Evaluate the Efficacy and Safety of Belimumab Plus Standard of Care Versus Placebo Plus Standard of Care in Adult Subjects with Active Lupus Nephritis
Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
Reata Pharmaceuticals, Inc.
Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: The Occurrence of Renal Events, (BEACON)
N/A
Amgen
Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT)
N/A
Hoffmann-La Roche
Assess the Efficacy and Safety of Mycophenolate Mofetil (MMF) In Inducing Response and Maintaining Remission in Subjects with Lupus Nephritis
Prospective, Randomized, Active Controlled, Parallel Group, Multi-Center Trial
Abbott
Evaluate the Survival Benefits of Zemplar Relative to Calcijex in Subjects with Stage V Chronic Kidney Disease on Hemodialysis
Phase 4, Prospective, Randomized, Active-Controlled, Double-Blind, Double-Dummy, Multi-Center Study
Pfizer
Linezolid vs. Vancomycin/Cefazolin in The Treatment of Hemodialysis Patients with Catheter Related Gram-Positive Bloodstream Infections
N/A

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