Iron Therapy in Patients With End-Stage Renal Disease

Not Applicable

• Conditions: End-stage Renal Disease; Anemia; Cardiovascular Risk Factor; Inflammation
• Interventions: Drug: irone sucrose

• Registration Number: NCT04491916
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-09
• Study Start: 2020-04-01
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-30
• Last Update Posted: 2020-07-30
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• patients receiving maintenance dialysis

Exclusion Criteria

• less than 20 year-old, oncological patients undergoing chemotherapy, abnormal liver function, infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iron Treatment	irone sucrose	Treatment with iron sucrose with orginal guideline from ferritin\>500ng/ml, or TSAT\>20% to ferritin\>800ng/ml, or TSAT\>50%.

Primary Outcome Measures

Name	Time	Method
Mortality	2 years	the death events following up until 2022
coronary artery disease	2 years	new onset coronary artery disease diagnosed with cardiac enzyme (\>troponins I upper limit 99%)
congestive heart failure	2 yearts	new onset congestive heart failure (brain natriuretic peptide\> 400pg/ml)

Secondary Outcome Measures

Name	Time	Method
liver function	2 years	abdominal sonography with Child classification of liver cirrhosis
phospate	2 years	serum phosphate level
calcium	2 years	serum total calcium level
potassium	2 years	serum potassium level
diabetes	2 years	glycated hemoglobin
nutrition status	2 years	serum albumin level
anemia	2 years	1. serum hemoglobin level; 2. serum hematocrit
sodium	2 years	serum sodium level
parathyroid function	2 years	serum parathyroid level

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan