End-stage Renal DiseaseNCT04491916
Iron Therapy in Patients With End-Stage Renal Disease
A study testing irone sucrose in people with End-stage Renal Disease and Anemia, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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%. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- End-stage Renal Disease, Anemia, Cardiovascular Risk Factor
- What is being tested?
- irone sucrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients receiving maintenance dialysis
Who cannot join
- less than 20 year-old, oncological patients undergoing chemotherapy, abnormal liver function, infection
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City
Hugo Y Lin, MD,PhD, 886-7-2911101 ext. 8737, yukenlin@gmail.com
About this study
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
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%.
Read the 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.
- Being tested
- irone sucrose
- Keywords
- iron, End-Stage Renal Disease, Anemia
- Medical subject headings
- Kidney Failure, Chronic, Anemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irone sucroseDrug
drug ingredient: Ferric Hydroxide in complex with sucrose drug dosage form: 270injection/100mg/5ml/Amp
| Study group | Role | What they receive |
|---|---|---|
| Iron Treatment | Experimental | Treatment with iron sucrose with orginal guideline from ferritin>500ng/ml, or TSAT>20% to ferritin>800ng/ml, or TSAT>50%. Receives: Drug: irone sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
the death events following up until 2022
Measured: 2 years
coronary artery disease
new onset coronary artery disease diagnosed with electrocardiogram (ST-segment changes, T inversion and Q wave appearance)
Measured: 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)
Measured: 2 years
coronary artery disease
new onset coronary artery disease diagnosed with cardiac enzyme (>troponins I upper limit 99%)
Measured: 2 years
congestive heart failure
new onset congestive heart failure diagnosed with sonocardiogram (HF-REF, heart failure with reduced EF≦ 35%)
Measured: 2 years
congestive heart failure
Progression of congestive heart failure (increase of NYHA classification)
Measured: 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
Measured: 2 years
congestive heart failure
new onset congestive heart failure (brain natriuretic peptide> 400pg/ml)
Measured: 2 yearts
Secondary outcomes (12)
diabetes
fasting blood sugar
Measured: 2 years
diabetes
postprandial blood sugar
Measured: 2 years
diabetes
glycated hemoglobin
Measured: 2 years
anemia
- serum hemoglobin level
- serum hematocrit
Measured: 2 years
calcium
serum total calcium level
Measured: 2 years
phospate
serum phosphate level
Measured: 2 years
nutrition status
serum albumin level
Measured: 2 years
liver function
serum AST/ALT level
Measured: 2 years
liver function
abdominal sonography with Child classification of liver cirrhosis
Measured: 2 years
sodium
serum sodium level
Measured: 2 years
potassium
serum potassium level
Measured: 2 years
parathyroid function
serum parathyroid level
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Apr 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugo Y Lin, MD,PhD, Principal investigator, Kaohsiung Medical UniversityHugo Y Lin, MD,PhD, Principal investigator, Kaohsiung Municipal Ta-Tung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491916
- Sponsor's protocol ID
- KMUHIRB-F(I)-20190110
- Status last verified
- Sep 2019
- First submitted
- 9 Apr 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04491916
- Acronym / sponsor ID
- KMUHIRB-F(I)-20190110
- Keywords
- iron, End-Stage Renal Disease, Anemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron Treatment | Experimental | Drug: irone sucroseTreatment with iron sucrose with orginal guideline from ferritin>500ng/ml, or TSAT>20% to ferritin>800ng/ml, or TSAT>50%. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients receiving maintenance dialysis
Key exclusion criteria (1 listed)
- less than 20 year-old, oncological patients undergoing chemotherapy, abnormal liver function, infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| irone sucrosedrug ingredient: Ferric Hydroxide in complex with sucrose drug dosage form: 270injection/100mg/5ml/Amp | Drug | Iron Treatment |
Primary outcome
Mortality
Time frame: 2 years
the death events following up until 2022
coronary artery disease
Time frame: 2 years
new onset coronary artery disease diagnosed with electrocardiogram (ST-segment changes, T inversion and Q wave appearance)
coronary artery disease
Time frame: 2 years
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
Time frame: 2 years
new onset coronary artery disease diagnosed with cardiac enzyme (>troponins I upper limit 99%)
congestive heart failure
Time frame: 2 years
new onset congestive heart failure diagnosed with sonocardiogram (HF-REF, heart failure with reduced EF≦ 35%)
congestive heart failure
Time frame: 2 years
Progression of congestive heart failure (increase of NYHA classification)
congestive heart failure
Time frame: 2 years
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
Time frame: 2 yearts
new onset congestive heart failure (brain natriuretic peptide> 400pg/ml)
12 secondary outcomes
diabetes
Time frame: 2 years
diabetes
Time frame: 2 years
diabetes
Time frame: 2 years
anemia
Time frame: 2 years
calcium
Time frame: 2 years
phospate
Time frame: 2 years
nutrition status
Time frame: 2 years
liver function
Time frame: 2 years
liver function
Time frame: 2 years
sodium
Time frame: 2 years
potassium
Time frame: 2 years
parathyroid function
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo Y Lin, MD,PhD principal investigator
Kaohsiung Medical University
Hugo Y Lin, MD,PhD principal investigator
Kaohsiung Municipal Ta-Tung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing irone sucrose in people with End-stage Renal Disease and Anemia, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hugo Y Lin, MD, PhD (886-7-2911101 ext. 8737, yukenlin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.