Effects of Carnitine on Oxidative Stress to IVIR Administration to CKD Patients:Impact of Haptoglobin Genotype

Not Applicable

• Conditions: Anemia
• Interventions: Drug: L-Canitine

• Registration Number: NCT02312414
• Lead Sponsor: The Nazareth Hospital, Israel

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-09
• Primary Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-15
• Last Update Posted: 2015-05-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IVIR Carnitine	L-Canitine	Patients given Carnitine (20mg/kg, IV) perior to IV iron (Sodium ferric gluconate, \[125 mg/100 ml\] from week 4 to week 8.

Primary Outcome Measures

Name	Time	Method
neutrophil gelatinase-associated lipocalin (NGAL),	1 month
AOPP (Advanced Oxidation Protein Products)	1 month

Secondary Outcome Measures

Name	Time	Method
Haptoglobin	1 month

Trial Locations

Locations (1)

Nazareth hospital (EMMS); 🇮🇱 Nazareth, Israel