Effect of Adding Lactoferrin on Oral Iron on Anemia in Chronic Kidney Disease Patients

NCT05900635 | Unknown Phase 4

• 1 other identifier: 0107174
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effects of adding lactoferrin to the every-other-day oral iron supplementation in iron deficiency anemia and chronic kidney disease patients.

Conditions

Anemia of Chronic Kidney Disease

Keywords

Lactoferrin; Anemia; Chronic Kidney Disease; Oral iron

Outcome Measures

Primary Outcomes (5)

• Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD

  Mean change in the level of Hemoglobin measured in gm/dl

  3 months

• Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD

  Mean change in the level of serum Iron measured in ug/mL

  3 months

• Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD

  Mean change in total iron binding capacity (TIBC) measured in ug/mL

  3 months

• Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD

  Mean change in serum transferrin saturation (TSAT) measured in %

  3 months

• Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD

  Mean change in serum hepcidin measured in ng/ml

  3 months

Secondary Outcomes (1)

• Evaluation of tolerability and gastrointestinal adverse events

  3 months

Study Arms (2)

Control

EXPERIMENTAL

Patients in this group will initiate treatment with oral ferrous glycine sulfate (100mg) every other day for 3 months

Drug: Ferrous Glycine Sulfate

Intervention

ACTIVE COMPARATOR

Patients in this group will initiate treatment with oral lactoferrin (one sachet that contains 100mg) with oral ferrous glycine sulfate (100mg) every other day for 3 months

Drug: Lactoferrin; Drug: Ferrous Glycine Sulfate

Interventions

Lactoferrin DRUG

Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients

Intervention

Ferrous Glycine Sulfate DRUG

Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients

Control; Intervention

Eligibility Criteria

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

You may qualify if:

• Males and Females aged ≥ 18 years old
• Patients with eGFR ≥30 and ≤60 mL/min/1.73m2.
• Absolute iron deficiency anemia (Hgb \<10g/dL, serum ferritin \<300ng/ml and Transferrin Saturation \< 30% )

You may not qualify if:

• Patients on intermittent hemodialysis (IHD)
• Patients with any known cause of anemia other than iron deficiency or CKD (e.g., sickle cell anemia)
• Patients who received EPO 4 weeks ago
• Patients who received IV Iron 8 weeks ago
• Patients who received blood Transfusion 8 weeks ago
• Current history of GI bleeding
• Malignancy history
• Pregnancy or lactation in female participants
• Patients non-adherent to at least 80% of the regimen

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Kidney and Urology Center

Alexandria, 21548, Egypt

RECRUITING

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

Lactoferrin; ferroglycine sulfate

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• Ahmed F Elkoraie, Prof

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Magda A Elmassik, Prof

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Noha A Hamdy, PhD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Engy M Emam, PharmD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Engy M Emam, Pharm D

CONTACT

01223534690; engyemam2005@gmail.com

Noha A Hamdy, PhD

CONTACT

01005182151; nohaalaaeldine@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open labeled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, open-labeled, parallel, randomised controlled trial

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: June 12, 2023
• Study Start: October 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)