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

Primary Purpose

Anemia of Chronic Kidney Disease

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Lactoferrin
Ferrous Glycine Sulfate
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia of Chronic Kidney Disease focused on measuring Lactoferrin, Anemia, Chronic Kidney Disease, Oral iron

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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% ) Exclusion Criteria: 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

Sites / Locations

  • Kidney and Urology CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Control

Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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
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 %
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

Secondary Outcome Measures

Evaluation of tolerability and gastrointestinal adverse events
The subjects will be contacted to be questioned about medications adherence and adverse events

Full Information

First Posted
February 4, 2023
Last Updated
June 10, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05900635
Brief Title
Effect of Adding Lactoferrin on Oral Iron on Anemia in Chronic Kidney Disease Patients
Official Title
Effect of Adding Lactoferrin to Oral Iron Supplementation for the Treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University. All participants should agree to take part in this clinical study and will provide informed consent. Sixty chronic kidney disease patients with iron defficiency anemia,will be recruited from the Kidney and Urology Center (KUC) and Alexandria main university hospital (AMUH). The 60 participants will be randomly assigned into 2 arms. Control arm (n=30): will be treated with oral ferrous glycine sulfate (100mg) every other day for 3 months Intervention arm (n=40): will be treated with oral lactoferrin (one sachet that contains 100mg) with oral ferrous glycine sulfate (100mg) every other day for 3 months. All patients will be subjected directly at time of enrollment to the following; Complete history taking and demographic data (age, sex, …) Blood samples will be drawn to measure the initial values of hemoglobin, hematocrit, serum iron, TIBC, Serum Transferrin Saturation (TSAT), and Hepcidin as primary outcome. All patients will be followed up and treated during the study time. All relevant routine investigations and medications will be recorded. At each visit, the subjects will be questioned about study compliance (diet and medications), concomitant medications, and adverse events. The results obtained from the work will be tabulated and statistically analyzed using the appropriate statistical methods. The findings will be discussed in view of the achievement of the aim, their significance and their comparison with other available works and information.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Chronic Kidney Disease
Keywords
Lactoferrin, Anemia, Chronic Kidney Disease, Oral iron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective, open-labeled, parallel, randomised controlled trial
Masking
None (Open Label)
Masking Description
open labeled
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
Patients in this group will initiate treatment with oral ferrous glycine sulfate (100mg) every other day for 3 months
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Lactoferrin
Intervention Description
Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients
Intervention Type
Drug
Intervention Name(s)
Ferrous Glycine Sulfate
Intervention Description
Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients
Primary Outcome Measure Information:
Title
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
Description
Mean change in the level of Hemoglobin measured in gm/dl
Time Frame
3 months
Title
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
Description
Mean change in the level of serum Iron measured in ug/mL
Time Frame
3 months
Title
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
Description
Mean change in total iron binding capacity (TIBC) measured in ug/mL
Time Frame
3 months
Title
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
Description
Mean change in serum transferrin saturation (TSAT) measured in %
Time Frame
3 months
Title
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
Description
Mean change in serum hepcidin measured in ng/ml
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Evaluation of tolerability and gastrointestinal adverse events
Description
The subjects will be contacted to be questioned about medications adherence and adverse events
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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% ) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Engy M Emam, Pharm D
Phone
01223534690
Email
engyemam2005@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Noha A Hamdy, PhD
Phone
01005182151
Email
nohaalaaeldine@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed F Elkoraie, Prof
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Magda A Elmassik, Prof
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Noha A Hamdy, PhD
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Engy M Emam, PharmD
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kidney and Urology Center
City
Alexandria
ZIP/Postal Code
21548
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed F El Koraie, PhD
Phone
01000304563
Email
drahmed@hotmail.com
First Name & Middle Initial & Last Name & Degree
Engy m Emam, PharmD
Phone
01223534690
Email
engyemam2005@gmail.com
First Name & Middle Initial & Last Name & Degree
Magda A El-Massik, PhD
First Name & Middle Initial & Last Name & Degree
Ahmed F El Koraie, PhD
First Name & Middle Initial & Last Name & Degree
Noha A Hamdy, PhD
First Name & Middle Initial & Last Name & Degree
Engy M Emam, PharmD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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