Iron Deficiency AnemiaPhase 4ALOHANCT04627181
Do Iron And Vitamin B12 Injections Given Together, Improve Hemoglobin In Patients On Hemodialysis?
A Phase 4 study testing Ferric carboxymaltose and Hydroxycobalamin in people with Iron Deficiency Anemia and B12 Deficiency Anemia, run by Christian Medical College, Vellore, India at 1 site in India.
Trial summary
A parallel group, quadruple blind, placebo-controlled, randomized control trial with 2x2 factorial design to determine the effect of simultaneous IV ferric carboxymaltose and IM hydroxycobalamin supplementation in anemic Indian HD patients Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Iron Deficiency Anemia, B12 Deficiency Anemia
- What is being tested?
- Ferric carboxymaltose and Hydroxycobalamin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 18 Nov 2020to Mar 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult prevalent HD patients on HD for at least 3 months with hemoglobin < 11 g/dL
Who cannot join
- Blood transfusion, blood loss, infection, surgery or change in haemoglobin by > 1 g/dL in the last 1 month
- Hemoglobinopathy
- Cirrhosis
- Hematological malignancy or myeloproliferative disorder
- HIV, HBV or HCV infection
- Any chronic inflammatory disorder
Show all 14Show fewer
- IV iron or oral/IM B12 received in the last 3 months
- Severe hyperparathyroidism (intact parathyroid hormone > 1,000 pg/mL)
- Pregnancy
- Age < 18 years
- History of asthma or eczema, any history of drug allergy, including allergy to iron preparations
- History of exposure to chemotherapy or cytotoxic drugs - 5-FU, hydroxyurea, hydroxycarbamide, methotrexate, trimethoprim, colchicine, azathioprine
- History of G-CSF use in the last 1 month
- General anaesthesia with nitrous oxide in the last 1 month
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Christian Medical College, Vellore
Vellore, Tamil Nadu, 632004
Anna T Valson, MD, DM, +919894143677, annavalson@cmcvellore.ac.in
Rizwan Alam, MD, +918130560297, rizwangb0557@gmail.com
About this study
Official title: The Role Of IV Iron (Ferric Carboxymaltose) And IM Vitamin B12 (Hydroxycobalamin) Supplementation In The Management Of Anaemic Prevalent Indian Hemodialysis Patients: A Parallel Group, Quadruple Blind, Placebo-Controlled, Pragmatic Randomized Control Trial With 2x2 Factorial Design
A parallel group, quadruple blind, placebo-controlled, randomized control trial with 2x2 factorial design to determine the effect of simultaneous IV ferric carboxymaltose and IM hydroxycobalamin supplementation in anemic Indian HD patients
- Conditions
- Iron Deficiency Anemia, B12 Deficiency Anemia
- Being tested
- Ferric carboxymaltose, Hydroxycobalamin, Placebo
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Single dose of ferric carboxymaltose (Encicarb, Emcure Pharmaceuticals Ltd., Pune, India) 500 mg administered intravenously in 100 ml normal saline over 1 hour via the dialysis blood line immediately following HD
HydroxycobalaminDrug
Single dose of hydroxycobalamine (Trineurosol Hp, Tridoss Laboratories, Mumbai, India) 1000 mcg administered intramuscularly in the deltoid of the non-fistula arm immediately following HD
PlaceboDrug
Single dose of 1 ml of distilled water injected intramuscularly in the deltoid of the non-fistula arm immediately following HD
PlaceboDrug
Single dose of 100 ml normal saline administered intravenously over 1 hour via the dialysis blood line immediately following HD
| Study group | Role | What they receive |
|---|---|---|
| FCM + placebo | Experimental | 1. Ferric carboxymaltose: Single dose, 500 mg
2. Placebo: Single dose Receives: Drug: Ferric carboxymaltose; Drug: Placebo |
| B12 + placebo | Experimental | 1. Hydroxycobalamine: Single dose, 1000 mcg
2. Placebo: Single dose Receives: Drug: Hydroxycobalamin; Drug: Placebo |
| FCM +B12 | Experimental | 1. Ferric carboxymaltose: Single dose, 500 mg
2. Hydroxycobalamine: Single dose, 1000 mcg Receives: Drug: Ferric carboxymaltose; Drug: Hydroxycobalamin |
| Placebo + placebo | Placebo comparator | 1. Placebo: Single dose
2. Placebo: Single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean haemoglobin
Mean haemoglobin measured 30 days after the intervention
Measured: 30 days
Secondary outcomes (6)
Sensitivity and specificity of baseline automated red cell indices, peripheral smear red cell indices, and iron indices for diagnosis of iron deficiency
Sensitivity and specificity of baseline peripheral smear hypochromic RBCs >10%, peripheral smear red blood cell anisocytosis > 10%, percentage hypochromic mature red cells (%HYPOm) >6%, reticulocyte hemoglobin content (CHr) < 30 pg, transferrin saturation (TSAT), and serum ferritin, for the diagnosis of iron deficiency anemia. Iron deficiency anemia is defined by an increase in corrected reticulocyte index (reticulocyte % x hematocrit/40) >1% at 7 days and/or increase in hemoglobin by ≥1 g/dL 30 days after administration of IV FCM in the FCM +placebo arm.
Measured: Baseline
Optimum cutoff for baseline automated red cell indices for the diagnosis of iron deficiency anemia using ROC curve analysis
Optimum cutoff of baseline %HYPOm and CHr for the diagnosis of iron deficiency anemia using ROC curve analysis. Iron deficiency anemia is defined by an increase in corrected reticulocyte index (reticulocyte % x hematocrit/40) >1% at 7 days and/or increase in hemoglobin by ≥1 g/dL 30 days after administration of IV FCM in the FCM +placebo arm.
Measured: Baseline
Sensitivity and specificity of baseline peripheral blood smear hypochromia, peripheral blood smear anisocytosis and automated red cell indices for the diagnosis of iron deficiency anemia in participants with TSAT < 30% and TSAT > =30%.
Sensitivity and specificity of > 10% hypochromic red blood cells on peripheral blood smear, >10% red blood cell anisocytosis on peripheral blood smear, %HYPOm > 6%, and CHr < 30 pg measured at baseline, for the diagnosis of iron deficiency anemia in participants with baseline TSAT < 30% and TSAT > 30% respectively. Iron deficiency anemia is defined by an increase in corrected reticulocyte index (reticulocyte % x hematocrit/40) >1% at 7 days and/or increase in hemoglobin by ≥1 g/dL 30 days after administration of IV FCM in the FCM +placebo arm.
Measured: Baseline
Sensitivity and specificity of baseline peripheral smear neutrophil hypersegmentation and cell population data for the diagnosis of B12 deficiency.
Sensitivity and specificity of baseline peripheral smear neutrophil hypersegmentation (>3 percent of neutrophils with ≥5 lobes or ≥1 neutrophil with ≥6 lobes per 100 neutrophils) and cell population data [mean neutrophil volume > 145 fl or mean monocyte volume > 168 fl] for the diagnosis of B12 deficiency. B12 deficiency is defined as an increase in corrected reticulocyte index > 1% (reticulocyte % x hematocrit/40) at 7 days and/or increase in hemoglobin by ≥1 g/dL 30 days after administration of IM hydroxycobalamin in the B12 + placebo group.
Measured: Baseline
Optimum cutoff of cell population data for the diagnosis of B12 deficiency using ROC curve analysis
Optimum cutoff of baseline mean neutrophil volume and mean monocyte volume for the diagnosis of B12 deficiency using ROC curve analysis. B12 deficiency is defined as an increase in corrected reticulocyte index > 1% (reticulocyte % x hematocrit/40) at 7 days and/or increase in hemoglobin by ≥1 g/dL 30 days after administration of IM hydroxycobalamin in the B12 + placebo group.
Measured: Baseline
Adverse effects of IV ferric carboxymaltose and IM hydroxycobalamin therapy
Any adverse events attributable to the use of IV ferric carboxymaltoise and/or IM hydroxycobalamin
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start18 Nov 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants will be randomized to one of four arms: IV ferric carboxymaltose + placebo, IM hydroxycobalamin + placebo, IV ferric carboxymaltose + IM hydroxycobalamin, placebo + placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Medical College, Vellore, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna T Valson, MD, DM, Study director, Christian Medical College, Vellore, IndiaRizwan Alam, MD, Principal investigator, Christian Medical College, Vellore, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627181
- Sponsor's protocol ID
- 12564 (INTERVEN) 29.01.2020
- Acronym
- ALOHA
- Status last verified
- Nov 2020
- First submitted
- 8 Nov 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (including data dictionaries) will be made available immediately after publication of the trial results for an indefinite time period.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Of IV Iron (Ferric Carboxymaltose) And IM Vitamin B12 (Hydroxycobalamin) Supplementation In The Management Of Anaemic Prevalent Indian Hemodialysis Patients: A Parallel Group, Quadruple Blind, Placebo-Controlled, Pragmatic Randomized Control Trial With 2x2 Factorial Design
- ClinicalTrials.gov ID
- NCT04627181
- Acronym / sponsor ID
- ALOHA / 12564 (INTERVEN) 29.01.2020
- Conditions
- Iron Deficiency Anemia, B12 Deficiency Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Christian Medical College, Vellore, IndiaUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 13 Nov 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.
A parallel group, quadruple blind, placebo-controlled, randomized control trial with 2x2 factorial design to determine the effect of simultaneous IV ferric carboxymaltose and IM hydroxycobalamin supplementation in anemic Indian HD patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomized to one of four arms: IV ferric carboxymaltose + placebo, IM hydroxycobalamin + placebo, IV ferric carboxymaltose + IM hydroxycobalamin, placebo + placebo
| Arm | Type | Receives |
|---|---|---|
| FCM + placebo | Experimental | Drug: Ferric carboxymaltose, Drug: Placebo1. Ferric carboxymaltose: Single dose, 500 mg 2. Placebo: Single dose |
| B12 + placebo | Experimental | Drug: Hydroxycobalamin, Drug: Placebo1. Hydroxycobalamine: Single dose, 1000 mcg 2. Placebo: Single dose |
| FCM +B12 | Experimental | Drug: Ferric carboxymaltose, Drug: Hydroxycobalamin1. Ferric carboxymaltose: Single dose, 500 mg 2. Hydroxycobalamine: Single dose, 1000 mcg |
| Placebo + placebo | Placebo comparator | Drug: Placebo1. Placebo: Single dose 2. Placebo: Single dose |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult prevalent HD patients on HD for at least 3 months with hemoglobin < 11 g/dL
Key exclusion criteria (14 listed)
- Blood transfusion, blood loss, infection, surgery or change in haemoglobin by > 1 g/dL in the last 1 month
- Hemoglobinopathy
- Cirrhosis
- Hematological malignancy or myeloproliferative disorder
- HIV, HBV or HCV 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 |
|---|---|---|
| Ferric carboxymaltoseSingle dose of ferric carboxymaltose (Encicarb, Emcure Pharmaceuticals Ltd., Pune, India) 500 mg administered intravenously in 100 ml normal saline over 1 hour via the dialysis blood line immediately following HD | Drug | FCM + placebo, FCM +B12 |
| HydroxycobalaminSingle dose of hydroxycobalamine (Trineurosol Hp, Tridoss Laboratories, Mumbai, India) 1000 mcg administered intramuscularly in the deltoid of the non-fistula arm immediately following HD | Drug | B12 + placebo, FCM +B12 |
| PlaceboSingle dose of 1 ml of distilled water injected intramuscularly in the deltoid of the non-fistula arm immediately following HD | Drug | FCM + placebo, Placebo + placebo |
| PlaceboSingle dose of 100 ml normal saline administered intravenously over 1 hour via the dialysis blood line immediately following HD | Drug | B12 + placebo, Placebo + placebo |
Primary outcome
Mean haemoglobin
Time frame: 30 days
Mean haemoglobin measured 30 days after the intervention
6 secondary outcomes
Sensitivity and specificity of baseline automated red cell indices, peripheral smear red cell indices, and iron indices for diagnosis of iron deficiency
Time frame: Baseline
Optimum cutoff for baseline automated red cell indices for the diagnosis of iron deficiency anemia using ROC curve analysis
Time frame: Baseline
Sensitivity and specificity of baseline peripheral blood smear hypochromia, peripheral blood smear anisocytosis and automated red cell indices for the diagnosis of iron deficiency anemia in participants with TSAT < 30% and TSAT > =30%.
Time frame: Baseline
Sensitivity and specificity of baseline peripheral smear neutrophil hypersegmentation and cell population data for the diagnosis of B12 deficiency.
Time frame: Baseline
Optimum cutoff of cell population data for the diagnosis of B12 deficiency using ROC curve analysis
Time frame: Baseline
Adverse effects of IV ferric carboxymaltose and IM hydroxycobalamin therapy
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: Yes. All individual participant data (including data dictionaries) will be made available immediately after publication of the trial results for an indefinite time period.
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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.
Anna T Valson, MD, DM study director
Christian Medical College, Vellore, India
Rizwan Alam, MD principal investigator
Christian Medical College, Vellore, India
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 Ferric carboxymaltose and Hydroxycobalamin in people with Iron Deficiency Anemia and B12 Deficiency Anemia, run by Christian Medical College, Vellore, India at 1 site in India.
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 14 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 29 Jan 2021. 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 India. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna T Valson, MD, DM (+91-416-2282683, annavalson@cmcvellore.ac.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean haemoglobin (time frame: 30 days). 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 29 Jan 2021.