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Clinical Trial Details

Trial ID: L1437
Source ID: NCT04491916
Associated Drug: Irone Sucrose
Title: Iron Therapy in Patients With End-Stage Renal Disease
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: End-stage Renal Disease|Anemia|Cardiovascular Risk Factor|Inflammation
Interventions: DRUG: irone sucrose
Outcome Measures: Primary: Mortality, the death events following up until 2022, 2 years|coronary artery disease, new onset coronary artery disease diagnosed with electrocardiogram (ST-segment changes, T inversion and Q wave appearance), 2 years|coronary artery disease, Progression of coronary artery disease (SCCT grading increase : 0% = no visible stenosis, 1-24% = minimal stenosis, 25-49% = mild stenosis, 50-69% = moderate stenosis, 70-99% = severe stenosis, 100% = occlusion), 2 years|coronary artery disease, new onset coronary artery disease diagnosed with cardiac enzyme (\>troponins I upper limit 99%), 2 years|congestive heart failure, new onset congestive heart failure diagnosed with sonocardiogram (HF-REF, heart failure with reduced EF≦ 35%), 2 years|congestive heart failure, Progression of congestive heart failure (increase of NYHA classification), 2 years|congestive heart failure, new onset congestive heart failure with symptoms (Framingham's clinical criteria: orthopnea, pulmonary rales, S3, paroxysmal nocturnal dyspnea, cough, dyspnea on ordinary exertion, pleural effusion, hepatomegaly, tachycardia with a heart rate over 120 beats/min, bilateral leg edema, and weight loss under 4.5 kg in five days) diagnosed by cardiologists, 2 years|congestive heart failure, new onset congestive heart failure (brain natriuretic peptide\> 400pg/ml), 2 yearts | Secondary: diabetes, fasting blood sugar, 2 years|diabetes, postprandial blood sugar, 2 years|diabetes, glycated hemoglobin, 2 years|anemia, 1. serum hemoglobin level 2. serum hematocrit, 2 years|calcium, serum total calcium level, 2 years|phospate, serum phosphate level, 2 years|nutrition status, serum albumin level, 2 years|liver function, serum AST/ALT level, 2 years|liver function, abdominal sonography with Child classification of liver cirrhosis, 2 years|sodium, serum sodium level, 2 years|potassium, serum potassium level, 2 years|parathyroid function, serum parathyroid level, 2 years
Sponsor/Collaborators: Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 200
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-04-01
Completion Date: 2022-12-31
Results First Posted:
Last Update Posted: 2020-07-30
Locations: Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
URL: https://clinicaltrials.gov/show/NCT04491916