NCT06556134CompletedPhase 4
Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients
Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients: A Non-Inferiority Study
Source: ClinicalTrials.gov · Last updated 15 Aug 2024
Brief summary (registry, in English)
This study aims to assess the comparative effects of intravenous and liposomal oral iron on hemoglobin levels in non-dialysis CKD patients. Additionally, it seeks to evaluate the rate of hemoglobin correction, iron reserve status during treatment, and therapeutic tolerance to these interventions.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 10 Aug 2024
- Start date
- 1 Jul 2021
- Primary completion date
- 1 Jul 2023
- Lead sponsor
- Centre Hospitalier Hassan II - Fès
- Diseases
- Chronic kidney disease
- NCT number
- NCT06556134
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 27
- From 1 Jul 2021 to the primary completion date, 1 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Exclusion criteria included presence of an inflammatory or infectious disease with a C-reactive protein (CRP) levels ≥6 mg/L at the beginning of the study ,surgical interventions in the last 3 months, hematological disorders including bleeding or blood transfusions in the last 6 months, malignancies, ongoing treatment with immunosuppressive drugs, severe malnutrition (BMI\<20Kg/m² ; Albuminemia \<32 g/L with normal values of C-reactive protein (CRP); Decrease in weight \>5% in 1 month or \>7.5% in 3 months), history of major CVD (Myocardial Infarction, Chronic Heart Failure, Stroke), chronic alcohol abuse, known hepatitis B or C infection, pregnant or lactating women, and need to start dialysis.
- Withdrawal from the study occurs in the case of severe anemia needing an urgent blood transfusion or non-adherence and withdrawal of consent.
Who the study is looking for
- Inclusion criteria for the study are age \>18 years, eGFR ≤60 mL/min/1.73 m2 (Modification of Diet in Renal Disease equation: MDRD), Hb levels ≤12 g/dL, ferritin levels ≤100 ng/mL, transferrin saturation (TSAT) ≤25%, parathormone (PTH) serum levels between 30 and 300 pg/mL.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nephrology, Dialysis, and Transplantation, Hassan II University Hospital Coordinator of this site? Confirm its status | Fes | Morocco | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.