Anemia of Chronic Kidney DiseasePhase 4NCT02787824
Periodic Versus Continuous IV Iron Supplementation in HD Patients
A Phase 4 study testing Iron Sucrose Supplement in people with Anemia of Chronic Kidney Disease, run by Papageorgiou General Hospital at 1 site in Greece.
Trial summary
The purpose of this study was to compare the efficacy of two regimens of intravenous iron sucrose [continuous (in every hemodialysis session) versus intermittent (every 1-4 weeks)] on the response of rHuEPO in the maintenance phase of its administration in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia of Chronic Kidney Disease
- What is being tested?
- Iron Sucrose Supplement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteGreece
- Study dates
- May 2016to Oct 2016
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Constant rHu-EPO and iron dose for at least 2 months before starting the study
- Hemoglobin ≥ 8,5g/dl and <12,5 g/dl
- Ferritin < 1000 mg/dl
- TSAT < 50%
- CRP < 5 mg/dl
Who cannot join
- Malignant tumor disease
- Oral iron supplementation
- Active bleeding issues
- Surgical intervention within the last 8 weeks before study inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periodic Versus Continuous (at Every Session of Hemodialysis) iv Iron Supplementation in Chronic HD Patients
The purpose of this study was to compare the efficacy of two regimens of intravenous iron sucrose [continuous (in every hemodialysis session) versus intermittent (every 1-4 weeks)] on the response of rHuEPO in the maintenance phase of its administration in hemodialysis patients.
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- Iron Sucrose Supplement
- Keywords
- iron deficiency, hemodialysis
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Sucrose SupplementDrug
| Study group | Role | What they receive |
|---|---|---|
| continuous iv administration of iron sucrose | Experimental | Prior to the study, all our patients were receiving intravenous iron sucrose in an intermittent mode (every 1-4 weeks).Patients on this arm will receive the same previous dose of iron glucose but in a continuous mode (smaller doses of iron sucrose in every session). Receives: Drug: Iron Sucrose Supplement |
| intermittent iv administration of iron sucrose | Active comparator | Patients on this arm will continue to receive the same previous intermittent mode of iron sucrose. Receives: Drug: Iron Sucrose Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum hemoglobin level (g/dl)
Measured: Month 0, 1, 2, 3, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papageorgiou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efstathios Mitsopoulos, Papageorgiou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787824
- Sponsor's protocol ID
- 637/13.7
- Status last verified
- May 2016
- First submitted
- 24 May 2016
- Last updated
- 20 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodic Versus Continuous (at Every Session of Hemodialysis) iv Iron Supplementation in Chronic HD Patients
- ClinicalTrials.gov ID
- NCT02787824
- Acronym / sponsor ID
- 637/13.7
- Conditions
- Anemia of Chronic Kidney Disease
- Keywords
- iron deficiency, hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Papageorgiou General HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Jun 2016 (estimated)
- 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.
The purpose of this study was to compare the efficacy of two regimens of intravenous iron sucrose [continuous (in every hemodialysis session) versus intermittent (every 1-4 weeks)] on the response of rHuEPO in the maintenance phase of its administration in hemodialysis patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous iv administration of iron sucrose | Experimental | Drug: Iron Sucrose SupplementPrior to the study, all our patients were receiving intravenous iron sucrose in an intermittent mode (every 1-4 weeks).Patients on this arm will receive the same previous dose of iron glucose but in a continuous mode (smaller doses of iron sucrose in every session). |
| intermittent iv administration of iron sucrose | Active comparator | Drug: Iron Sucrose SupplementPatients on this arm will continue to receive the same previous intermittent mode of iron sucrose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Constant rHu-EPO and iron dose for at least 2 months before starting the study
- Hemoglobin ≥ 8,5g/dl and <12,5 g/dl
- Ferritin < 1000 mg/dl
- TSAT < 50%
- CRP < 5 mg/dl
Key exclusion criteria (4 listed)
- Malignant tumor disease
- Oral iron supplementation
- Active bleeding issues
- Surgical intervention within the last 8 weeks before study inclusion
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 |
|---|---|---|
| Iron Sucrose Supplement | Drug | continuous iv administration of iron sucrose, intermittent iv administration of iron sucrose |
Primary outcome
Change of serum hemoglobin level (g/dl)
Time frame: Month 0, 1, 2, 3, 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
Related trials for Anemia of Chronic Kidney Disease
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Not yet recruitingPhase 1
Study of CTX001 in Adults With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease
Chronic Kidney Disease, Anemia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron Sucrose Supplement in people with Anemia of Chronic Kidney Disease, run by Papageorgiou General Hospital at 1 site in Greece.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 20 Sep 2017. 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 Greece. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum hemoglobin level (g/dl) (time frame: Month 0, 1, 2, 3, 4). 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 20 Sep 2017.