Iron Therapy in Patients With End-Stage Renal Disease

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04491916
• Other study ID #: KMUHIRB-F(I)-20190110
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2019
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Hugo Y Lin, MD, PhD
• Phone: 886-7-2911101
• Email: yukenlin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

Inclusion Criteria:

• patients receiving maintenance dialysis

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anemia
• Cardiovascular Risk Factor
• End-stage Renal Disease
• Inflammation
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• irone sucrose
drug ingredient: Ferric Hydroxide in complex with sucrose drug dosage form: 270injection/100mg/5ml/Amp

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	the death events following up until 2022	2 years
Primary	coronary artery disease	new onset coronary artery disease diagnosed with electrocardiogram (ST-segment changes, T inversion and Q wave appearance)	2 years
Primary	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
Primary	coronary artery disease	new onset coronary artery disease diagnosed with cardiac enzyme (>troponins I upper limit 99%)	2 years
Primary	congestive heart failure	new onset congestive heart failure diagnosed with sonocardiogram (HF-REF, heart failure with reduced EF? 35%)	2 years
Primary	congestive heart failure	Progression of congestive heart failure (increase of NYHA classification)	2 years
Primary	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
Primary	congestive heart failure	new onset congestive heart failure (brain natriuretic peptide> 400pg/ml)	2 yearts
Secondary	diabetes	fasting blood sugar	2 years
Secondary	diabetes	postprandial blood sugar	2 years
Secondary	diabetes	glycated hemoglobin	2 years
Secondary	anemia	serum hemoglobin level; serum hematocrit	2 years
Secondary	calcium	serum total calcium level	2 years
Secondary	phospate	serum phosphate level	2 years
Secondary	nutrition status	serum albumin level	2 years
Secondary	liver function	serum AST/ALT level	2 years
Secondary	liver function	abdominal sonography with Child classification of liver cirrhosis	2 years
Secondary	sodium	serum sodium level	2 years
Secondary	potassium	serum potassium level	2 years
Secondary	parathyroid function	serum parathyroid level	2 years