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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVIR | No Intervention | Patients given IV iron (Sodium ferric gluconate, [125 mg/100 ml] from week 1 to week 4 | |
| IVIR Carnitine | Experimental | Patients given Carnitine (20mg/kg, IV) perior to IV iron (Sodium ferric gluconate, [125 mg/100 ml] from week 4 to week 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-Canitine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AOPP (Advanced Oxidation Protein Products) | 1 month | |
| neutrophil gelatinase-associated lipocalin (NGAL), | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Haptoglobin | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zaher Armaly, M.D. | Contact | +972546693498 | zaherarmaly@nazhosp.com |
| Name | Affiliation | Role |
|---|---|---|
| Amir Abd El Qader, Ph.D | Nazareth EMMS Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nazareth hospital (EMMS) | Recruiting | Nazareth | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26268514 | Derived | Armaly Z, Abd El Qader A, Jabbour A, Hassan K, Ramadan R, Bowirrat A, Bisharat B. Effects of carnitine on oxidative stress response to intravenous iron administration to patients with CKD: impact of haptoglobin phenotype. BMC Nephrol. 2015 Aug 13;16:135. doi: 10.1186/s12882-015-0119-0. |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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