Do Iron And Vitamin B12 Injections Given Together, Improve Hemoglobin In Patients On Hemodialysis? (ALOHA)

Christian Medical College, Vellore, India

Status and phase: Unknown; Phase 4

Conditions: Iron Deficiency Anemia; B12 Deficiency Anemia

Treatments: Drug: Ferric carboxymaltose; Drug: Placebo; Drug: Hydroxycobalamin

Study type: Interventional

Funder types: Other

Identifiers

NCT04627181

12564 (INTERVEN) 29.01.2020

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All adult prevalent HD patients on HD for at least 3 months with hemoglobin < 11 g/dL

Exclusion criteria

• 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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups, including a placebo group

FCM + placebo

Experimental group

Description:

1. Ferric carboxymaltose: Single dose, 500 mg 2. Placebo: Single dose

Treatment:

Drug: Ferric carboxymaltose

Drug: Placebo

Drug: Placebo

B12 + placebo

Experimental group

Description:

1. Hydroxycobalamine: Single dose, 1000 mcg 2. Placebo: Single dose

Treatment:

Drug: Hydroxycobalamin

Drug: Placebo

Drug: Placebo

FCM +B12

Experimental group

Description:

1. Ferric carboxymaltose: Single dose, 500 mg 2. Hydroxycobalamine: Single dose, 1000 mcg

Treatment:

Drug: Ferric carboxymaltose

Drug: Hydroxycobalamin

Placebo + placebo

Placebo Comparator group

Description:

1. Placebo: Single dose 2. Placebo: Single dose

Treatment:

Drug: Placebo

Drug: Placebo