CKDNCT06521216
Different Oral Iron Dosing Regimens in Treatment of Iron Deficency Anemia in Patients With Chronic Kidney Disease
An observational study of CKD, run by Assiut University.
Trial summary
Comparing between the efficacy of alternate day oral iron dose, once daily and thrice daily dose in improving anemia in CKD patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD
- What is being tested?
- Ferrous sulfate
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Aug 2025
- Phase
- Observational
- 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
Study population: All adult patients above 18 years old with CKD stages 2,3 and 4
Who may be able to join
- All adult patients above 18 years old with CKD stages 2,3 and 4
Who cannot join
- CKD stage 5 (eGFR below 15 ).
- Patients with hemolytic anemias.
- Chronic liver diseases .
- Autoimmune diseases.
- Malignancy
- History of blood transfusion last 3 months before the study
- Pregnancy
- Adult polycystic kidney disease ( APCKD)
Trial locations and contacts
No sites are listed yet.
Youmna Refaat, Professor contact
About this study
Official title: Comparing Different Oral Iron Dosing Regimens in Treatment of Iron Deficiency Anemia in Patients With Chronic Kidney Disease
Comparing between the efficacy of alternate day oral iron dose, once daily and thrice daily dose in improving anemia in CKD patients
Read the detailed description
Anemia is common in chronic kidney disease (CKD) and has been associated with impaired quality of life, cardiovascular disease (CVD) and mortality.
Iron deficiency is common in patients with CKD and an important modifiable factor in treatment of anemia.
In particular, the Kidney Disease: Improving Global Outcomes (KDIGO) anemia work group guidelines define anemia in CKD as a hemoglobin concentration of <13.0 g/dL in men and <12.0 g/dL in women. The current guidelines recommend trial of iron supplementation in CKD when increase in hemoglobin concentration or decrease in erythropoietin dose is desired and investigations reveal percentage transferrin saturation (%TSAT) ≤ 30% and serum ferritin ≤ 500 ng/ml.
The absorption of iron from gastro-intestinal tract and release of iron from reticuloendothelial cells for erythropoiesis are tightly regulated through hepcidin-ferroportin axis. Hepcidin concentrations increase in response to iron excess and inflammation. CKD is associated with elevated hepcidin and ferritin concentrations due to underlying inflammation, independent of iron status.
Iron-deficiency anemia in individuals with CKD may result from functional iron deficiency, absolute iron deficiency, or both. The factors contributing to functional iron deficiency are chronic inflammation and poor hepcidin clearance seen in CKD, whereas absolute iron deficiency includes poor gastrointestinal (GI) dietary iron absorption and blood loss.
In patients with CKD who are not on dialysis, oral route may be preferred as initial mode of iron supplementation. Oral iron is inexpensive, self-administered, convenient and easily available.
Three different oral iron supplement strategies-once daily, multidose per day, and alternate-day dose-improve hemoglobin (Hgb) and iron indices in patients with iron deficiency anemia and chronic kidney disease (CKD).
Study showed that daily doses of oral iron reduced its absorption by increasing serum hepcidin levels. This study also found that administration of oral iron on alternate days as single doses improved iron absorption.
Theoretically, using lower doses and increasing time interval between consecutive doses might reduce the amount of unabsorbed iron in the gastrointestinal tract resulting in lesser gastrointestinal side effects. However, the major concern with alternate day dosing is that only half the total amount of iron is supplemented per unit time compared to daily dosing.
More recent data suggest that lower doses and infrequent administration may be as effective as the traditional regimen while probably associated with lower rates of adverse effects.
Investigators will investigate the effect of every other day, once daily and three times a day dosing of oral iron formulation on measures of iron sufficiency in patients with stages 2,3 and 4 CKD through a randomized controlled trial.
- Conditions
- CKD
- Being tested
- Ferrous sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulfateDrug
all patients will receive 200 mg elemental iron (ferrous sulphate)
| Study group | Role | What they receive |
|---|---|---|
| patients will receive oral iron in alternate day regimen | 50 patients will receive oral ferrous sulphate in alternate day regimen Receives: Drug: Ferrous sulfate | |
| patients will receive oral iron in single daily dose regimen | 50 patients will receive oral ferrous sulphate in single daily dose regimen Receives: Drug: Ferrous sulfate | |
| patients will receive oral iron in thrice daily dose regimen | 50 patients will receive oral ferrous sulphate in thrice daily dose regimen Receives: Drug: Ferrous sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin level by gm/dl
Follow up Hemoglobin level in 3 groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CKDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farrag Sayed Mohamed, Assiut University
- Investigators
- Farrag S Mohamed, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521216
- Sponsor's protocol ID
- Oral iron in CKD patients
- Status last verified
- Jul 2024
- First submitted
- 1 Jun 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stoffel NU, Cercamondi CI, Brittenham G, Zeder C, Geurts-Moespot AJ, Swinkels DW, Moretti D, Zimmermann MB. Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials. Lancet Haematol. 2017 Nov;4(11):e524-e533. doi: 10.1016/S2352-3026(17)30182-5. Epub 2017 Oct 9.
PubMed 29032957
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Different Oral Iron Dosing Regimens in Treatment of Iron Deficiency Anemia in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06521216
- Acronym / sponsor ID
- Oral iron in CKD patients
- Conditions
- CKD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 25 Jul 2024 (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.
Comparing between the efficacy of alternate day oral iron dose, once daily and thrice daily dose in improving anemia in CKD patients
Detailed description
Anemia is common in chronic kidney disease (CKD) and has been associated with impaired quality of life, cardiovascular disease (CVD) and mortality.
Iron deficiency is common in patients with CKD and an important modifiable factor in treatment of anemia.
In particular, the Kidney Disease: Improving Global Outcomes (KDIGO) anemia work group guidelines define anemia in CKD as a hemoglobin concentration of <13.0 g/dL in men and <12.0 g/dL in women. The current guidelines recommend trial of iron supplementation in CKD when increase in hemoglobin concentration or decrease in erythropoietin dose is desired and investigations reveal percentage transferrin saturation (%TSAT) ≤ 30% and serum ferritin ≤ 500 ng/ml.
The absorption of iron from gastro-intestinal tract and release of iron from reticuloendothelial cells for erythropoiesis are tightly regulated through hepcidin-ferroportin axis. Hepcidin concentrations increase in response to iron excess and inflammation. CKD is associated with elevated hepcidin and ferritin concentrations due to underlying inflammation, independent of iron status.
Iron-deficiency anemia in individuals with CKD may result from functional iron deficiency, absolute iron deficiency, or both. The factors contributing to functional iron deficiency are chronic inflammation and poor hepcidin clearance seen in CKD, whereas absolute iron deficiency includes poor gastrointestinal (GI) dietary iron absorption and blood loss.
In patients with CKD who are not on dialysis, oral route may be preferred as initial mode of iron supplementation. Oral iron is inexpensive, self-administered, convenient and easily available.
Three different oral iron supplement strategies-once daily, multidose per day, and alternate-day dose-improve hemoglobin (Hgb) and iron indices in patients with iron deficiency anemia and chronic kidney disease (CKD).
Study showed that daily doses of oral iron reduced its absorption by increasing serum hepcidin levels. This study also found that administration of oral iron on alternate days as single doses improved iron absorption.
Theoretically, using lower doses and increasing time interval between consecutive doses might reduce the amount of unabsorbed iron in the gastrointestinal tract resulting in lesser gastrointestinal side effects. However, the major concern with alternate day dosing is that only half the total amount of iron is supplemented per unit time compared to daily dosing.
More recent data suggest that lower doses and infrequent administration may be as effective as the traditional regimen while probably associated with lower rates of adverse effects.
Investigators will investigate the effect of every other day, once daily and three times a day dosing of oral iron formulation on measures of iron sufficiency in patients with stages 2,3 and 4 CKD through a randomized controlled trial.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients will receive oral iron in alternate day regimen | – | Drug: Ferrous sulfate50 patients will receive oral ferrous sulphate in alternate day regimen |
| patients will receive oral iron in single daily dose regimen | – | Drug: Ferrous sulfate50 patients will receive oral ferrous sulphate in single daily dose regimen |
| patients will receive oral iron in thrice daily dose regimen | – | Drug: Ferrous sulfate50 patients will receive oral ferrous sulphate in thrice daily dose regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients above 18 years old with CKD stages 2,3 and 4
Key inclusion criteria (1 listed)
- All adult patients above 18 years old with CKD stages 2,3 and 4
Key exclusion criteria (8 listed)
- CKD stage 5 (eGFR below 15 ).
- Patients with hemolytic anemias.
- Chronic liver diseases .
- Autoimmune diseases.
- Malignancy
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 |
|---|---|---|
| Ferrous sulfateall patients will receive 200 mg elemental iron (ferrous sulphate) | Drug | patients will receive oral iron in alternate day regimen, patients will receive oral iron in single daily dose regimen, patients will receive oral iron in thrice daily dose regimen |
Primary outcome
Change in Hemoglobin level by gm/dl
Time frame: 6 months
Follow up Hemoglobin level in 3 groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Background: PubMed 29032957Stoffel NU, Cercamondi CI, Brittenham G, Zeder C, Geurts-Moespot AJ, Swinkels DW, Moretti D, Zimmermann MB. Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials. Lancet Haematol. 2017 Nov;4(11):e524-e533. doi: 10.1016/S2352-3026(17)30182-5. Epub 2017 Oct 9.
- Sood, V., Kamboj, K., Bhatia, P. et al. A randomized trial of once daily versus twice daily dosing of oral iron in CKD. Sci Rep 13, 141 (2023). https://doi.org/10.1038/s41598-022-26589-xLink provided by the sponsor.
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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.
Youmna Refaat, Professor contact
Farrag S Mohamed study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of CKD, run by Assiut University.
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 8 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 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Farrag S Mohamed, MD (0201064274671, faragsayed99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin level by gm/dl (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06521216, which also lists 1 linked publication.
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 25 Jul 2024.