Anemia
Conditions
Brief summary
Anemia is a common disorder in CKD patients. It is largely attributed to decreased erythropoietin (EPO) production and iron deficiency. Therefore, besides EPO, therapy includes iron replenishment. However, the latter induces oxidative stress. Haptoglobin (Hp) protein is the main line of defense against the oxidative effects of Hemoglobin/Iron. There are 3 genotypes: 1-1, 2-1 and 2-2. Hp 2-2 protein is inferior to Hp 1-1 as antioxidant. So far, there is no evidence whether haptoglobin genotype affects iron-induced oxidative stress in CKD patients. In this proposed study we wished to examine whether Hp genotype influences intravenous iron administration (IVIR)-induced oxidative stress in CKD patients, and its impact on the response of these patients to L-Carnitine therapy.
Detailed description
This study will include at least 25 anemic CKD patients (stages 3-4) that will be given a weekly IVIR (Sodium ferric gluconate, \[125 mg/100 ml\] for 8 weeks, and during weeks 5-8 also received Carnitine (20mg/kg, IV) prior to IVIR. Weekly blood samples will drawn before and after each IVIR for Hp genotype, C-reactive protein (CRP), advanced oxidative protein products (AOPP), neutrophil gelatinase-associated lipocalin (NGAL), besides complete blood count and biochemical analyses.
Interventions
DRUGL-Canitine
Carnitine is a quaternary ammonium compound biosynthesized from the amino acids lysine and methionine, it is essential for the transport of fatty acids from the intermembraneous space in the mitochondria, into the mitochondrial matrix during the breakdown of lipids (fats) for the generation of metabolic energy
Sponsors
The Nazareth Hospital, Israel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients that have been diagnosed as suffering from chronic kidney diseases at stages 3-4 and confirmed by MDRD. 2. CKD patients with Hb of less than 10 g%. 3. At age ≥18 y.
Exclusion criteria
1. Pregnant women. 2. Patient with CKD stage 5 on Dialysis. 3. Patients with severe liver diseases. 4. Patients with severe CHF. 5. Inter-current illness such as fever. 6. Allergic rhinitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AOPP (Advanced Oxidation Protein Products) | 1 month |
| neutrophil gelatinase-associated lipocalin (NGAL), | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Haptoglobin | 1 month |
Countries
Israel
Contacts
Primary ContactZaher Armaly, M.D.
Outcome results
None listed