Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-02 @ 5:08 AM
Study NCT ID:
NCT05900635
Status:
UNKNOWN
Last Update Posted:
2023-06-12
First Post:
2023-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Adding Lactoferrin on Oral Iron on Anemia in Chronic Kidney Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007781', 'term': 'Lactoferrin'}, {'id': 'C030676', 'term': 'ferroglycine sulfate'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061250', 'term': 'Transferrins'}, {'id': 'D033862', 'term': 'Iron-Binding Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007782', 'term': 'Lactoglobulins'}, {'id': 'D000067816', 'term': 'Whey Proteins'}, {'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D008667', 'term': 'Metalloproteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'open labeled'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, open-labeled, parallel, randomised controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-10', 'studyFirstSubmitDate': '2023-02-04', 'studyFirstSubmitQcDate': '2023-06-10', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'description': 'Mean change in the level of Hemoglobin measured in gm/dl'}, {'measure': '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', 'description': 'Mean change in the level of serum Iron measured in ug/mL'}, {'measure': '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', 'description': 'Mean change in total iron binding capacity (TIBC) measured in ug/mL'}, {'measure': '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', 'description': 'Mean change in serum transferrin saturation (TSAT) measured in %'}, {'measure': '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', 'description': 'Mean change in serum hepcidin measured in ng/ml'}], 'secondaryOutcomes': [{'measure': 'Evaluation of tolerability and gastrointestinal adverse events', 'timeFrame': '3 months', 'description': 'The subjects will be contacted to be questioned about medications adherence and adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lactoferrin', 'Anemia', 'Chronic Kidney Disease', 'Oral iron'], 'conditions': ['Anemia of Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '1. Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University.\n2. All participants should agree to take part in this clinical study and will provide informed consent.\n3. 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).\n\n The 60 participants will be randomly assigned into 2 arms.\n\n Control arm (n=30): will be treated with oral ferrous glycine sulfate (100mg) every other day for 3 months\n\n 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.\n4. All patients will be subjected directly at time of enrollment to the following; Complete history taking and demographic data (age, sex, …)\n5. 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.\n6. All patients will be followed up and treated during the study time. All relevant routine investigations and medications will be recorded.\n7. At each visit, the subjects will be questioned about study compliance (diet and medications), concomitant medications, and adverse events.\n8. The results obtained from the work will be tabulated and statistically analyzed using the appropriate statistical methods.\n9. The findings will be discussed in view of the achievement of the aim, their significance and their comparison with other available works and information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and Females aged ≥ 18 years old\n2. Patients with eGFR ≥30 and ≤60 mL/min/1.73m2.\n3. Absolute iron deficiency anemia (Hgb \\<10g/dL, serum ferritin \\<300ng/ml and Transferrin Saturation \\< 30% )\n\nExclusion Criteria:\n\n1. Patients on intermittent hemodialysis (IHD)\n2. Patients with any known cause of anemia other than iron deficiency or CKD (e.g., sickle cell anemia)\n3. Patients who received EPO 4 weeks ago\n4. Patients who received IV Iron 8 weeks ago\n5. Patients who received blood Transfusion 8 weeks ago\n6. Current history of GI bleeding\n7. Malignancy history\n8. Pregnancy or lactation in female participants\n9. Patients non-adherent to at least 80% of the regimen'}, 'identificationModule': {'nctId': 'NCT05900635', 'briefTitle': 'Effect of Adding Lactoferrin on Oral Iron on Anemia in Chronic Kidney Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effect of Adding Lactoferrin to Oral Iron Supplementation for the Treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients', 'orgStudyIdInfo': {'id': '0107174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Patients in this group will initiate treatment with oral ferrous glycine sulfate (100mg) every other day for 3 months', 'interventionNames': ['Drug: Ferrous Glycine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', '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', 'interventionNames': ['Drug: Lactoferrin', 'Drug: Ferrous Glycine Sulfate']}], 'interventions': [{'name': 'Lactoferrin', 'type': 'DRUG', 'description': 'Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients', 'armGroupLabels': ['Intervention']}, {'name': 'Ferrous Glycine Sulfate', 'type': 'DRUG', 'description': 'Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21548', 'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed F El Koraie, PhD', 'role': 'CONTACT', 'email': 'drahmed@hotmail.com', 'phone': '01000304563'}, {'name': 'Engy m Emam, PharmD', 'role': 'CONTACT', 'email': 'engyemam2005@gmail.com', 'phone': '01223534690'}, {'name': 'Magda A El-Massik, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ahmed F El Koraie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Noha A Hamdy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Engy M Emam, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kidney and Urology Center', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Engy M Emam, Pharm D', 'role': 'CONTACT', 'email': 'engyemam2005@gmail.com', 'phone': '01223534690'}, {'name': 'Noha A Hamdy, PhD', 'role': 'CONTACT', 'email': 'nohaalaaeldine@yahoo.com', 'phone': '01005182151'}], 'overallOfficials': [{'name': 'Ahmed F Elkoraie, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}, {'name': 'Magda A Elmassik, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}, {'name': 'Noha A Hamdy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}, {'name': 'Engy M Emam, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}