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Clinical Trial Details

Trial ID: L0151
Source ID: NCT05745883
Associated Drug: Disc-0974
Title: Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants with CKD and Anemia
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases|Anemia of Chronic Kidney Disease
Interventions: DRUG: DISC-0974|DRUG: Placebo
Outcome Measures: Primary: Incidence of treatment-emergent adverse events, up to 145 days|Incidence of clinically abnormal vital signs, up to 145 days|Incidence of abnormal laboratory test results, up to 145 days|Incidence of clinically abnormal physical exam, up to 145 days|Incidence of clinically abnormal electrocardiograms, up to 145 days | Secondary: Change from baseline in concentration of iron laboratory parameter, up to 145 days|Change from baseline in concentration of hematologic laboratory parameters, up to 145 days|Cmax-Maximum drug concentration measured in plasma, up to 145 days|Tmax-Time of maximum drug concentration, up to 145 days|AUC-Area under the drug concentration time curve, up to 145 days|T½ - Elimination half life of the drug, up to 145 days|CL/F-Apparent drug clearance (only for single-dose portion), up to 57 days|Vz/F; Vss/F -Apparent volume of distribution of the drug (only for single-dose portion), up to 57 days
Sponsor/Collaborators: Sponsor: Disc Medicine, Inc
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 50
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-04-04
Completion Date: 2026-05
Results First Posted:
Last Update Posted: 2024-11-15
Locations: Rocky Mountain Kidney Care - Lone Tree, Lone Tree, Colorado, 80124, United States|Accel Research, DeLand, Florida, 32720, United States|Total Research Group, Miami, Florida, 33126, United States|Flourish Research, Winter Park, Florida, 32789, United States|Nephrology and Hypertension Specialists, PC-Dalton, Dalton, Georgia, 30720, United States|Boise Kidney & Hypertension PLLC, Nampa, Idaho, 83687, United States|Center for Advanced Kidney Research PLC, Saint Clair Shores, Michigan, 48081, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|Centricity Research, Columbus, Ohio, 43213, United States|Clinical Advancement Center, PLLC, San Antonio, Texas, 78212, United States|Endeavor Clinical Trials, San Antonio, Texas, 78240, United States|Washington Nephrology Associates, LLP, Alexandria, Virginia, 22304, United States
URL: https://clinicaltrials.gov/show/NCT05745883

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress