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

NCT04627181 | Unknown Phase 4 DMC

• 1 other identifier: 12564 (INTERVEN) 29.01.2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Iron Deficiency Anemia; B12 Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Mean haemoglobin

  Mean haemoglobin measured 30 days after the intervention

  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

  Baseline

• Optimum cutoff for baseline automated red cell indices for the diagnosis of iron deficiency anemia using ROC curve analysis

  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%.

  Baseline

• Sensitivity and specificity of baseline peripheral smear neutrophil hypersegmentation and cell population data for the diagnosis of B12 deficiency.

  Baseline

• Optimum cutoff of cell population data for the diagnosis of B12 deficiency using ROC curve analysis

  Baseline

Other Outcomes (2)

• Exploratory: Sensitivity and specificity of red cell anisochromia on peripheral smear for the diagnosis of iron deficiency anemia

  Baseline

• Optimal cutoff of baseline serum methylmalonic acid for the diagnosis of B12 deficiency

  Baseline

Study Arms (4)

FCM + placebo

EXPERIMENTAL

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

Drug: Ferric carboxymaltose; Drug: Placebo

B12 + placebo

EXPERIMENTAL

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

Drug: Hydroxycobalamin; Drug: Placebo

FCM +B12

EXPERIMENTAL

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

Drug: Ferric carboxymaltose; Drug: Hydroxycobalamin

Placebo + placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ferric carboxymaltose DRUG

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

FCM + placebo; FCM +B12

Hydroxycobalamin DRUG

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

B12 + placebo; FCM +B12

Placebo DRUG

Single dose of 1 ml of distilled water injected intramuscularly in the deltoid of the non-fistula arm immediately following HD

FCM + placebo; Placebo + placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christian Medical College, Vellore, India: lead

Study Sites (1)

Christian Medical College, Vellore

Vellore, Tamil Nadu, 632004, India

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; Hydroxocobalamin

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Vitamin B 12; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Anna T Valson, MD, DM

  Christian Medical College, Vellore, India

  STUDY DIRECTOR

• Rizwan Alam, MD

  Christian Medical College, Vellore, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna T Valson, MD, DM

CONTACT

+91-416-2282683; annavalson@cmcvellore.ac.in

Rizwan Alam, MD

CONTACT

+91-416-2282053; rizwangb0557@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of four arms: IV ferric carboxymaltose + placebo, IM hydroxycobalamin + placebo, IV ferric carboxymaltose + IM hydroxycobalamin, placebo + placebo

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: November 13, 2020
• Study Start: November 18, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: January 29, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately after publication of the results, for an indefinite period
• Access Criteria: IPD will be made available to investigators whose proposed use of the data has been approved by an independent review committee in order to achieve aims in the approved proposal. Proposals should be directed to annavalson@cmcvellore.ac.in. To gain access, data requestors will need to sign a data access agreement. Data will be made available at the third party website.

Locations

IN (1)