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Iron Therapy in Patients With End-Stage Renal Disease

Primary Purpose

End-stage Renal Disease, Anemia, Cardiovascular Risk Factor

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
irone sucrose
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease focused on measuring iron, End-Stage Renal Disease, Anemia

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients receiving maintenance dialysis

Exclusion Criteria:

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

Sites / Locations

  • Kaohsiung Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iron Treatment

Arm Description

Treatment with iron sucrose with orginal guideline from ferritin>500ng/ml, or TSAT>20% to ferritin>800ng/ml, or TSAT>50%.

Outcomes

Primary Outcome Measures

Mortality
the death events following up until 2022
coronary artery disease
new onset coronary artery disease diagnosed with electrocardiogram (ST-segment changes, T inversion and Q wave appearance)
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)
coronary artery disease
new onset coronary artery disease diagnosed with cardiac enzyme (>troponins I upper limit 99%)
congestive heart failure
new onset congestive heart failure diagnosed with sonocardiogram (HF-REF, heart failure with reduced EF≦ 35%)
congestive heart failure
Progression of congestive heart failure (increase of NYHA classification)
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
congestive heart failure
new onset congestive heart failure (brain natriuretic peptide> 400pg/ml)

Secondary Outcome Measures

diabetes
fasting blood sugar
diabetes
postprandial blood sugar
diabetes
glycated hemoglobin
anemia
serum hemoglobin level serum hematocrit
calcium
serum total calcium level
phospate
serum phosphate level
nutrition status
serum albumin level
liver function
serum AST/ALT level
liver function
abdominal sonography with Child classification of liver cirrhosis
sodium
serum sodium level
potassium
serum potassium level
parathyroid function
serum parathyroid level

Full Information

First Posted
April 9, 2020
Last Updated
July 27, 2020
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04491916
Brief Title
Iron Therapy in Patients With End-Stage Renal Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease, Anemia, Cardiovascular Risk Factor, Inflammation
Keywords
iron, End-Stage Renal Disease, Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iron Treatment
Arm Type
Experimental
Arm Description
Treatment with iron sucrose with orginal guideline from ferritin>500ng/ml, or TSAT>20% to ferritin>800ng/ml, or TSAT>50%.
Intervention Type
Drug
Intervention Name(s)
irone sucrose
Intervention Description
drug ingredient: Ferric Hydroxide in complex with sucrose drug dosage form: 270injection/100mg/5ml/Amp
Primary Outcome Measure Information:
Title
Mortality
Description
the death events following up until 2022
Time Frame
2 years
Title
coronary artery disease
Description
new onset coronary artery disease diagnosed with electrocardiogram (ST-segment changes, T inversion and Q wave appearance)
Time Frame
2 years
Title
coronary artery disease
Description
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)
Time Frame
2 years
Title
coronary artery disease
Description
new onset coronary artery disease diagnosed with cardiac enzyme (>troponins I upper limit 99%)
Time Frame
2 years
Title
congestive heart failure
Description
new onset congestive heart failure diagnosed with sonocardiogram (HF-REF, heart failure with reduced EF≦ 35%)
Time Frame
2 years
Title
congestive heart failure
Description
Progression of congestive heart failure (increase of NYHA classification)
Time Frame
2 years
Title
congestive heart failure
Description
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
Time Frame
2 years
Title
congestive heart failure
Description
new onset congestive heart failure (brain natriuretic peptide> 400pg/ml)
Time Frame
2 yearts
Secondary Outcome Measure Information:
Title
diabetes
Description
fasting blood sugar
Time Frame
2 years
Title
diabetes
Description
postprandial blood sugar
Time Frame
2 years
Title
diabetes
Description
glycated hemoglobin
Time Frame
2 years
Title
anemia
Description
serum hemoglobin level serum hematocrit
Time Frame
2 years
Title
calcium
Description
serum total calcium level
Time Frame
2 years
Title
phospate
Description
serum phosphate level
Time Frame
2 years
Title
nutrition status
Description
serum albumin level
Time Frame
2 years
Title
liver function
Description
serum AST/ALT level
Time Frame
2 years
Title
liver function
Description
abdominal sonography with Child classification of liver cirrhosis
Time Frame
2 years
Title
sodium
Description
serum sodium level
Time Frame
2 years
Title
potassium
Description
serum potassium level
Time Frame
2 years
Title
parathyroid function
Description
serum parathyroid level
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients receiving maintenance dialysis Exclusion Criteria: less than 20 year-old, oncological patients undergoing chemotherapy, abnormal liver function, infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hugo Y Lin, MD, PhD
Phone
886-7-2911101
Ext
8737
Email
yukenlin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo Y Lin, MD,PhD
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hugo Y Lin, MD,PhD
Organizational Affiliation
Kaohsiung Municipal Ta-Tung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Y Lin, MD,PhD
Phone
886-7-2911101
Ext
8737
Email
yukenlin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Iron Therapy in Patients With End-Stage Renal Disease

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