Anemia of Chronic Kidney DiseasePhase 4NCT06556134
Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients
A Phase 4 study testing Intravenous Iron Sucrose and Oral Iron in people with Anemia of Chronic Kidney Disease, run by Centre Hospitalier Hassan II - Fès at 1 site in Morocco.
Trial summary
This study aims to assess the comparative effects of intravenous and liposomal oral iron on hemoglobin levels in non-dialysis CKD patients. Additionally, it seeks to evaluate the rate of hemoglobin correction, iron reserve status during treatment, and therapeutic tolerance to these interventions. 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?
- Intravenous Iron Sucrose and Oral Iron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Jul 2021to 10 Jan 2024
- 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
- Inclusion criteria for the study are age >18 years, eGFR ≤60 mL/min/1.73 m2 (Modification of Diet in Renal Disease equation: MDRD), Hb levels ≤12 g/dL, ferritin levels ≤100 ng/mL, transferrin saturation (TSAT) ≤25%, parathormone (PTH) serum levels between 30 and 300 pg/mL.
Who cannot join
- Exclusion criteria included presence of an inflammatory or infectious disease with a C-reactive protein (CRP) levels ≥6 mg/L at the beginning of the study ,surgical interventions in the last 3 months, hematological disorders including bleeding or blood transfusions in the last 6 months, malignancies, ongoing treatment with immunosuppressive drugs, severe malnutrition (BMI<20Kg/m² ; Albuminemia <32 g/L with normal values of C-reactive protein (CRP); Decrease in weight >5% in 1 month or >7.5% in 3 months), history of major CVD (Myocardial Infarction, Chronic Heart Failure, Stroke), chronic alcohol abuse, known hepatitis B or C infection, pregnant or lactating women, and need to start dialysis.
- Withdrawal from the study occurs in the case of severe anemia needing an urgent blood transfusion or non-adherence and withdrawal of consent.
Trial locations and contacts
1 site in 1 country.
Morocco1 site
Nephrology, Dialysis, and Transplantation, Hassan II University Hospital
Fes, Fès-Meknes, 30050
About this study
Official title: Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients: A Non-Inferiority Study
This study aims to assess the comparative effects of intravenous and liposomal oral iron on hemoglobin levels in non-dialysis CKD patients. Additionally, it seeks to evaluate the rate of hemoglobin correction, iron reserve status during treatment, and therapeutic tolerance to these interventions.
Read the detailed description
The last two and a half decades have seen erythropoiesis-stimulating agents (ESAs) and iron therapy at the forefront of managing anemia in chronic kidney disease (CKD) patients. While ESAs have demonstrated significant efficacy in alleviating anemia in this context, recent large-scale randomized controlled trials in both non-dialysis and dialysis CKD patients have shed light on their limitations. Attempts to normalize hemoglobin (Hb) levels with ESAs have shown no significant cardiovascular benefits but have been associated with increased risks of adverse events such as stroke and venous thromboembolism.
Consequently, there has been a reduction in ESA prescription and an increase in blood transfusions, coupled with a notable rise in the use of iron therapy due to its role in addressing hypo responsiveness to ESAs.
Anemia stands as a common complication in CKD, significantly impacting cardiovascular health and quality of life. While renal erythropoietin production deficit remains a primary cause, iron deficiency plays a pivotal role in CKD-related anemia genesis. Iron deficiency, whether absolute or functional, alongside an inflammatory block, often seen in CKD patients, accounts for the main reasons behind hypo responsiveness to erythropoiesis-stimulating agents.
The recent shift in focus from ESA-centered treatment to iron therapy has prompted debates regarding the ideal route of iron administration, particularly in non-dialysis CKD patients. Despite the benefits of oral iron-cost-effectiveness and ease of administration-its usage remains limited due to poor gastrointestinal absorption and high adverse event rates. Conversely, concerns about IV iron revolve around potential kidney damage, infections, atherosclerosis promotion, and other adverse reactions.
Given these considerations, our study aims to compare the efficacy of oral liposomal iron against IV iron in treating anemia in non-dialysis CKD patients in terms of :
- Martial status under treatment.
- Hemoglobin level and its correction speed.
- Therapeutic tolerance.
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- Intravenous Iron Sucrose, Oral Iron
- Keywords
- hemoglobin, transferrin saturation, ferritin, liposomal iron, intravenous iron sucrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Iron SucroseDrug
Also called Fermed® 100mg
Intravenous iron-hydroxide sucrose complex administered in a dose of 100 mg, diluted in 250 mL of normal saline, and infused weekly for a period of 3 months
Oral IronDrug
Also called Lisofer® 30mg
One oral capsule per day, containing 30 mg of pyrophosphate liposomal iron and 70 mg of ascorbic acid
| Study group | Role | What they receive |
|---|---|---|
| GROUP IV | Active comparator | Group IV received intravenous iron-hydroxide sucrose complex (marketed as Fermed® 100mg), administered in a dose of 100 mg, diluted in 250 mL of normal saline, and infused weekly for a period of 3 month Receives: Drug: Intravenous Iron Sucrose |
| GROUP OS | Active comparator | Group OS received one oral capsule per day, containing 30 mg of pyrophosphate liposomal iron and 70 mg of ascorbic acid (marketed as Lisofer® 30mg), for the same 3-month duration Receives: Drug: Oral Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin elevation and its correction speed
Clinical guidelines define a target hemoglobin range that indicates successful correction. Hemoglobin is measured in g/dL.
Measured: Assessments were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5)
Secondary outcomes (2)
Ferritin serum levels
Ferritin levels, measured in ng/mL, serve as a reliable indicator of the body's iron reserves, reflecting overall iron storage.
Measured: Assessments of ferritin levels were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5)
Transferrin saturation
Transferrin saturation, expressed as a percentage (%), is a reliable indicator of iron availability in the body. The combination of ferritin levels (ng/mL) and transferrin saturation (%) provides the most reliable assessment of the body's iron status, offering a comprehensive view of both iron storage and availability.
Measured: Assessments of transferrin saturation were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Jul 2021
- Primary completion1 Jul 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Hassan II - Fès
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tariq Sqalli Houssaini, MD, Study director, Laboratory of Epidemiology and Health Science Research, Sidi Mohammed Ben Abdellah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556134
- Sponsor's protocol ID
- PREFER
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) often won't be shared with other researchers to protect participants' privacy and confidentiality. Sharing IPD could risk revealing personal information, even if anonymized, which might lead to re-identification. Additionally, there are ethical or legal obligations, informed consent restrictions, and concerns about misuse or misinterpretation of the data that necessitate keeping it restricted.
Publications
Pisani A, Riccio E, Sabbatini M, Andreucci M, Del Rio A, Visciano B. Effect of oral liposomal iron versus intravenous iron for treatment of iron deficiency anaemia in CKD patients: a randomized trial. Nephrol Dial Transplant. 2015 Apr;30(4):645-52. doi: 10.1093/ndt/gfu357. Epub 2014 Nov 13.
PubMed 25395392Agrawal S, Sonawane S, Kumar S, Acharya S, Gaidhane SA, Wanjari A, Kabra R, Phate N, Ahuja A. Efficacy of Oral Versus Injectable Iron in Patients With Chronic Kidney Disease: A Two-Year Cross-Sectional Study Conducted at a Rural Teaching Hospital. Cureus. 2022 Jul 31;14(7):e27529. doi: 10.7759/cureus.27529. eCollection 2022 Jul.
PubMed 36060352Macdougall IC, Bock AH, Carrera F, Eckardt KU, Gaillard C, Van Wyck D, Roubert B, Nolen JG, Roger SD; FIND-CKD Study Investigators. FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia. Nephrol Dial Transplant. 2014 Nov;29(11):2075-84. doi: 10.1093/ndt/gfu201. Epub 2014 Jun 2.
PubMed 24891437
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients: A Non-Inferiority Study
- ClinicalTrials.gov ID
- NCT06556134
- Acronym / sponsor ID
- PREFER
- Conditions
- Anemia of Chronic Kidney Disease
- Keywords
- hemoglobin, transferrin saturation, ferritin, liposomal iron, intravenous iron sucrose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centre Hospitalier Hassan II - FèsUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 15 Aug 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.
This study aims to assess the comparative effects of intravenous and liposomal oral iron on hemoglobin levels in non-dialysis CKD patients. Additionally, it seeks to evaluate the rate of hemoglobin correction, iron reserve status during treatment, and therapeutic tolerance to these interventions.
Detailed description
The last two and a half decades have seen erythropoiesis-stimulating agents (ESAs) and iron therapy at the forefront of managing anemia in chronic kidney disease (CKD) patients. While ESAs have demonstrated significant efficacy in alleviating anemia in this context, recent large-scale randomized controlled trials in both non-dialysis and dialysis CKD patients have shed light on their limitations. Attempts to normalize hemoglobin (Hb) levels with ESAs have shown no significant cardiovascular benefits but have been associated with increased risks of adverse events such as stroke and venous thromboembolism.
Consequently, there has been a reduction in ESA prescription and an increase in blood transfusions, coupled with a notable rise in the use of iron therapy due to its role in addressing hypo responsiveness to ESAs.
Anemia stands as a common complication in CKD, significantly impacting cardiovascular health and quality of life. While renal erythropoietin production deficit remains a primary cause, iron deficiency plays a pivotal role in CKD-related anemia genesis. Iron deficiency, whether absolute or functional, alongside an inflammatory block, often seen in CKD patients, accounts for the main reasons behind hypo responsiveness to erythropoiesis-stimulating agents.
The recent shift in focus from ESA-centered treatment to iron therapy has prompted debates regarding the ideal route of iron administration, particularly in non-dialysis CKD patients. Despite the benefits of oral iron-cost-effectiveness and ease of administration-its usage remains limited due to poor gastrointestinal absorption and high adverse event rates. Conversely, concerns about IV iron revolve around potential kidney damage, infections, atherosclerosis promotion, and other adverse reactions.
Given these considerations, our study aims to compare the efficacy of oral liposomal iron against IV iron in treating anemia in non-dialysis CKD patients in terms of :
- Martial status under treatment.
- Hemoglobin level and its correction speed.
- Therapeutic tolerance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP IV | Active comparator | Drug: Intravenous Iron SucroseGroup IV received intravenous iron-hydroxide sucrose complex (marketed as Fermed® 100mg), administered in a dose of 100 mg, diluted in 250 mL of normal saline, and infused weekly for a period of 3 month |
| GROUP OS | Active comparator | Drug: Oral IronGroup OS received one oral capsule per day, containing 30 mg of pyrophosphate liposomal iron and 70 mg of ascorbic acid (marketed as Lisofer® 30mg), for the same 3-month duration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria for the study are age >18 years, eGFR ≤60 mL/min/1.73 m2 (Modification of Diet in Renal Disease equation: MDRD), Hb levels ≤12 g/dL, ferritin levels ≤100 ng/mL, transferrin saturation (TSAT) ≤25%, parathormone (PTH) serum levels between 30 and 300 pg/mL.
Key exclusion criteria (2 listed)
- Exclusion criteria included presence of an inflammatory or infectious disease with a C-reactive protein (CRP) levels ≥6 mg/L at the beginning of the study ,surgical interventions in the last 3 months, hematological disorders including bleeding or blood transfusions in the last 6 months, malignancies, ongoing treatment with immunosuppressive drugs, severe malnutrition (BMI<20Kg/m² ; Albuminemia <32 g/L with normal values of C-reactive protein (CRP); Decrease in weight >5% in 1 month or >7.5% in 3 months), history of major CVD (Myocardial Infarction, Chronic Heart Failure, Stroke), chronic alcohol abuse, known hepatitis B or C infection, pregnant or lactating women, and need to start dialysis.
- Withdrawal from the study occurs in the case of severe anemia needing an urgent blood transfusion or non-adherence and withdrawal of consent.
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 |
|---|---|---|
| Intravenous Iron SucroseAlso: Fermed® 100mgIntravenous iron-hydroxide sucrose complex administered in a dose of 100 mg, diluted in 250 mL of normal saline, and infused weekly for a period of 3 months | Drug | GROUP IV |
| Oral IronAlso: Lisofer® 30mgOne oral capsule per day, containing 30 mg of pyrophosphate liposomal iron and 70 mg of ascorbic acid | Drug | GROUP OS |
Primary outcome
Hemoglobin elevation and its correction speed
Time frame: Assessments were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5)
Clinical guidelines define a target hemoglobin range that indicates successful correction. Hemoglobin is measured in g/dL.
2 secondary outcomes
Ferritin serum levels
Time frame: Assessments of ferritin levels were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5)
Transferrin saturation
Time frame: Assessments of transferrin saturation were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5)
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 15 Aug 2024.
- Results publication: PubMed 25395392Pisani A, Riccio E, Sabbatini M, Andreucci M, Del Rio A, Visciano B. Effect of oral liposomal iron versus intravenous iron for treatment of iron deficiency anaemia in CKD patients: a randomized trial. Nephrol Dial Transplant. 2015 Apr;30(4):645-52. doi: 10.1093/ndt/gfu357. Epub 2014 Nov 13.
- Results publication: PubMed 36060352Agrawal S, Sonawane S, Kumar S, Acharya S, Gaidhane SA, Wanjari A, Kabra R, Phate N, Ahuja A. Efficacy of Oral Versus Injectable Iron in Patients With Chronic Kidney Disease: A Two-Year Cross-Sectional Study Conducted at a Rural Teaching Hospital. Cureus. 2022 Jul 31;14(7):e27529. doi: 10.7759/cureus.27529. eCollection 2022 Jul.
- Results publication: PubMed 24891437Macdougall IC, Bock AH, Carrera F, Eckardt KU, Gaillard C, Van Wyck D, Roubert B, Nolen JG, Roger SD; FIND-CKD Study Investigators. FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia. Nephrol Dial Transplant. 2014 Nov;29(11):2075-84. doi: 10.1093/ndt/gfu201. Epub 2014 Jun 2.
- Individual participant dataSharing planned: No. Individual participant data (IPD) often won't be shared with other researchers to protect participants' privacy and confidentiality. Sharing IPD could risk revealing personal information, even if anonymized, which might lead to re-identification. Additionally, there are ethical or legal obligations, informed consent restrictions, and concerns about misuse or misinterpretation of the data that necessitate keeping it restricted.
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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.
Tariq Sqalli Houssaini, MD study director
Laboratory of Epidemiology and Health Science Research, Sidi Mohammed Ben Abdellah University
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 Intravenous Iron Sucrose and Oral Iron in people with Anemia of Chronic Kidney Disease, run by Centre Hospitalier Hassan II - Fès at 1 site in Morocco.
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 2 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 15 Aug 2024. 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 Morocco. 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?
Hemoglobin elevation and its correction speed (time frame: Assessments were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5)). 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 NCT06556134, which also lists 3 linked publications.
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 15 Aug 2024.