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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 |
Contact
Tel: 404-252-3744 Fax: 404-252-1489
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