Do Iron And Vitamin B12 Injections Given Together, Improve Hemoglobin In Patients On Hemodialysis?
NCT ID: NCT04627181
Last Updated: 2021-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2020-11-18
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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FCM + placebo
1. Ferric carboxymaltose: Single dose, 500 mg
2. Placebo: Single dose
Ferric carboxymaltose
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
Placebo
Single dose of 1 ml of distilled water injected intramuscularly in the deltoid of the non-fistula arm immediately following HD
B12 + placebo
1. Hydroxycobalamine: Single dose, 1000 mcg
2. Placebo: Single dose
Hydroxycobalamin
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
Placebo
Single dose of 100 ml normal saline administered intravenously over 1 hour via the dialysis blood line immediately following HD
FCM +B12
1. Ferric carboxymaltose: Single dose, 500 mg
2. Hydroxycobalamine: Single dose, 1000 mcg
Ferric carboxymaltose
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
Hydroxycobalamin
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
Placebo + placebo
1. Placebo: Single dose
2. Placebo: Single dose
Placebo
Single dose of 1 ml of distilled water injected intramuscularly in the deltoid of the non-fistula arm immediately following HD
Placebo
Single dose of 100 ml normal saline administered intravenously over 1 hour via the dialysis blood line immediately following HD
Interventions
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Ferric carboxymaltose
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
Hydroxycobalamin
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
Placebo
Single dose of 1 ml of distilled water injected intramuscularly in the deltoid of the non-fistula arm immediately following HD
Placebo
Single dose of 100 ml normal saline administered intravenously over 1 hour via the dialysis blood line immediately following HD
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Hemoglobinopathy
* Cirrhosis
* Hematological malignancy or myeloproliferative disorder
* HIV, HBV or HCV infection
* Any chronic inflammatory disorder
* 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
18 Years
90 Years
ALL
No
Sponsors
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Christian Medical College, Vellore, India
OTHER
Responsible Party
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Principal Investigators
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Anna T Valson, MD, DM
Role: STUDY_DIRECTOR
Christian Medical College, Vellore, India
Rizwan Alam, MD
Role: PRINCIPAL_INVESTIGATOR
Christian Medical College, Vellore, India
Locations
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Christian Medical College, Vellore
Vellore, Tamil Nadu, India
Countries
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Central Contacts
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Facility Contacts
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Anna T Valson, MD, DM
Role: primary
Rizwan Alam, MD
Role: backup
Other Identifiers
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12564 (INTERVEN) 29.01.2020
Identifier Type: -
Identifier Source: org_study_id