Iron Therapy in Patients With End-Stage Renal Disease

Study Overview
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Brief Summary
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This study will compare the clinical outcome of patients with maintenance dialysis room after changing the iron treatment guidelines from original upper limit with ferritin>500ng/ml, or TSAT>20% to Ferritin> 800ng / ml, or TSAT> 50%.

Detailed Description
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After two years of treatments, we will compare the incidence of clinical events, monthly blood, and biochemical examination data for the two years before and after the change.

Official Title
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A Cross-over Trial to Evaluate the Efficacy and Safety Between Increasing the Dose of Iron and Original Iron Dosage in Patients With Maintenance Hemodialysis

Conditions
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End-stage Renal Disease, Anemia, Cardiovascular Risk Factor, Inflammation

Intervention / Treatment
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* Drug: irone sucrose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients receiving maintenance dialysis Exclusion Criteria: less than 20 year-old, oncological patients undergoing chemotherapy, abnormal liver function, infection

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron Treatment<br>Treatment with iron sucrose with orginal guideline from ferritin>500ng/ml, or TSAT>20% to ferritin>800ng/ml, or TSAT>50%. | Drug: irone sucrose<br>* drug ingredient: Ferric Hydroxide in complex with sucrose drug dosage form: 270injection/100mg/5ml/Amp<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diabetes | fasting blood sugar | 2 years | 
| diabetes | postprandial blood sugar | 2 years | 
| diabetes | glycated hemoglobin | 2 years | 
| anemia | serum hemoglobin level 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron, End-Stage Renal Disease, Anemia