Anemia in Chronic Renal DiseasePhase 4NCT00308490
Changes in Iron Markers Following Iron Loading in Hemodialysis Patients
A Phase 4 study testing iron sucrose in people with Anemia in Chronic Renal Disease, run by Papageorgiou General Hospital at 1 site in Greece.
Trial summary
The purpose of this study is to describe alterations of serum ferritin, transferrin saturation, soluble transferrin receptor, % hypochromic erythrocytes, % reticulocytes, reticulocyte hemoglobin content after iron loading in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia in Chronic Renal Disease
- What is being tested?
- iron sucrose
- How many people
- 160 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2005to Jan 2007
- 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
- hemodialysis for three months minimum
- stable epoetin dose for two months minimum
- serum ferritin concentration < 1000 ng/ml
- transferrin saturation < 50%
- parathormone concentration < 800 pg/ml
Who cannot join
- hemoglobin concentration > 13g/dl
- serum ferritin concentration < 20 ng/ml
- vitamin B12 and/or folic deficiency
- other hematologic disease than anemia
- cancer
- hypothyroidism
- infectious disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study of Iron Indices' Kinetics in Hemodialysis Patients
The purpose of this study is to describe alterations of serum ferritin, transferrin saturation, soluble transferrin receptor, % hypochromic erythrocytes, % reticulocytes, reticulocyte hemoglobin content after iron loading in hemodialysis patients.
- Conditions
- Anemia in Chronic Renal Disease
- Being tested
- iron sucrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron sucroseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferritin alterations after iron loading at six and twelve weeks from the beginning of iron loading.
Secondary outcomes (1)
All iron indices' alterations during twelve weeks from the beginning of iron loading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study startSep 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia in Chronic Renal 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Papageorgiou General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Efstathios Mitsopoulos, MD, Principal investigator, Papageorgiou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308490
- Sponsor's protocol ID
- 48/31-1-2005
- Status last verified
- Sep 2006
- First submitted
- 28 Mar 2006
- Last updated
- 13 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Iron Indices' Kinetics in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00308490
- Acronym / sponsor ID
- 48/31-1-2005
- Conditions
- Anemia in Chronic Renal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- Papageorgiou General HospitalUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Jan 2007
- First posted
- 29 Mar 2006 (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 is to describe alterations of serum ferritin, transferrin saturation, soluble transferrin receptor, % hypochromic erythrocytes, % reticulocytes, reticulocyte hemoglobin content after iron loading in hemodialysis patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- hemodialysis for three months minimum
- stable epoetin dose for two months minimum
- serum ferritin concentration < 1000 ng/ml
- transferrin saturation < 50%
- parathormone concentration < 800 pg/ml
Key exclusion criteria (7 listed)
- hemoglobin concentration > 13g/dl
- serum ferritin concentration < 20 ng/ml
- vitamin B12 and/or folic deficiency
- other hematologic disease than anemia
- cancer
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 | Drug | – |
Primary outcome
Ferritin alterations after iron loading at six and twelve weeks from the beginning of iron loading.
1 secondary outcome
All iron indices' alterations during twelve weeks from the beginning of iron loading.
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 13 Mar 2007.
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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.
Efstathios Mitsopoulos, MD principal investigator
Papageorgiou General Hospital
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 in people with Anemia in Chronic Renal 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 7 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 13 Mar 2007. 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?
Ferritin alterations after iron loading at six and twelve weeks from the beginning of iron loading.. 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 13 Mar 2007.