Iron Therapy in Patients With End-Stage Renal Disease

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

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%.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Anemia; Cardiovascular Risk Factor; End-stage Renal Disease
• Intervention / Treatment: Drug: irone sucrose

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hugo Y Lin, MD, PhD; Phone Number: 8737 886-7-2911101; Email: yukenlin@gmail.com

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Recruiting
    • Kaohsiung Medical University Hospital
    • Contact: Hugo Y Lin, MD,PhD; Phone Number: 8737 886-7-2911101; Email: yukenlin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients receiving maintenance dialysis

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: Hugo Y Lin, MD,PhD, Kaohsiung Medical University; Principal Investigator: Hugo Y Lin, MD,PhD, Kaohsiung Municipal Ta-Tung Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (ACTUAL): July 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Anemia; iron; End-Stage Renal Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Inflammation; Kidney Failure, Chronic
• Other Study ID Numbers: KMUHIRB-F(I)-20190110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No