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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04491916
Enrollment
200
Registered
2020-07-30
Start date
2020-04-01
Completion date
2022-12-31
Last updated
2020-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Cardiovascular Risk Factor, End-stage Renal Disease, Inflammation

Keywords

iron, End-Stage Renal Disease, Anemia

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.

Interventions

DRUGirone sucrose

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

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* patients receiving maintenance dialysis

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality2 yearsthe death events following up until 2022
coronary artery disease2 yearsnew onset coronary artery disease diagnosed with electrocardiogram (ST-segment changes, T inversion and Q wave appearance)
congestive heart failure2 yearsnew onset congestive heart failure diagnosed with sonocardiogram (HF-REF, heart failure with reduced EF≦ 35%)

Secondary

MeasureTime frameDescription
phospate2 yearsserum phosphate level
nutrition status2 yearsserum albumin level
liver function2 yearsserum AST/ALT level
diabetes2 yearsfasting blood sugar
potassium2 yearsserum potassium level
parathyroid function2 yearsserum parathyroid level
sodium2 yearsserum sodium level
anemia2 years1. serum hemoglobin level 2. serum hematocrit
calcium2 yearsserum total calcium level

Countries

Taiwan

Contacts

Primary ContactHugo Y Lin, MD, PhD
yukenlin@gmail.com886-7-2911101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026