| Trial ID: | L0554 |
| Source ID: | NCT06556134
|
| Associated Drug: |
Intravenous Iron Sucrose
|
| Title: |
Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia of Chronic Kidney Disease
|
| Interventions: |
DRUG: Intravenous Iron Sucrose|DRUG: Oral Iron
|
| Outcome Measures: |
Primary: Hemoglobin elevation and its correction speed, Clinical guidelines define a target hemoglobin range that indicates successful correction. Hemoglobin is measured in g/dL., Assessments were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5) | Secondary: Ferritin serum levels, Ferritin levels, measured in ng/mL, serve as a reliable indicator of the body's iron reserves, reflecting overall iron storage., Assessments of ferritin levels were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5)|Transferrin saturation, Transferrin saturation, expressed as a percentage (%), is a reliable indicator of iron availability in the body. The combination of ferritin levels (ng/mL) and transferrin saturation (%) provides the most reliable assessment of the body's iron status, offering a comprehensive view of both iron storage and availability., Assessments of transferrin saturation were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5)
|
| Sponsor/Collaborators: |
Sponsor: Centre Hospitalier Hassan II - Fès
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
27
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
|
| Start Date: |
2021-07-01
|
| Completion Date: |
2024-01-10
|
| Results First Posted: |
|
| Last Update Posted: |
2024-08-15
|
| Locations: |
Nephrology, Dialysis, and Transplantation, Hassan II University Hospital, Fès, Fès-Meknes, 30050, Morocco
|
| URL: |
https://clinicaltrials.gov/show/NCT06556134
|
