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

Sponsors

Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Source 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.

Overall Status Recruiting
Start Date April 1, 2020
Completion Date December 31, 2022
Primary Completion Date December 31, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Mortality 2 years
coronary artery disease 2 years
coronary artery disease 2 years
coronary artery disease 2 years
congestive heart failure 2 years
congestive heart failure 2 years
congestive heart failure 2 years
congestive heart failure 2 yearts
Secondary Outcome
Measure Time Frame
diabetes 2 years
diabetes 2 years
diabetes 2 years
anemia 2 years
calcium 2 years
phospate 2 years
nutrition status 2 years
liver function 2 years
liver function 2 years
sodium 2 years
potassium 2 years
parathyroid function 2 years
Enrollment 200
Condition
Intervention

Intervention Type: Drug

Intervention Name: irone sucrose

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

Arm Group Label: Iron Treatment

Eligibility

Criteria:

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

Gender: All

Minimum Age: 20 Years

Maximum Age: 99 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Hugo Y Lin, MD, PhD

Phone: 886-7-2911101

Phone Ext.: 8737

Email: [email protected]

Location
Facility: Status: Contact: Kaohsiung Medical University Hospital Hugo Y Lin, MD,PhD 886-7-2911101 8737 [email protected]
Location Countries

Taiwan

Verification Date

September 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Iron Treatment

Type: Experimental

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

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov