UnknownPhase 4

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

Egypt60 participantsStarted 2022-10-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 3 months

Trial details

NCT IDNCT05900635

SponsorAlexandria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06

Contact for this trial

Engy M Emam, Pharm D

01223534690 engyemam2005@gmail.com

View on ClinicalTrials.gov More Anemia of Chronic Kidney Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 3 months