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 range18 Years

SexALL

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

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 range18 Years

SexALL

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