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

Anemia Clinical Trial

Official title:

Effects of Carnitine on Oxidative Stress and Inflammatory Responses to Intravenous Iron Administration to Patients With CKD: Impact of Haptoglobin Genotype

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02312414
• Other study ID #: 5700858
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2014
• Last updated: May 15, 2015
• Start date: October 2014

Study information

• Verified date: May 2015
• Source: The Nazareth Hospital, Israel
• Contact: Zaher Armaly, M.D.
• Phone: +972546693498
• Email: zaherarmaly[@]nazhosp.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• L-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

Locations

Country	Name	City	State
Israel	Nazareth hospital (EMMS)	Nazareth

Sponsors (1)

Lead Sponsor	Collaborator
The Nazareth Hospital, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AOPP (Advanced Oxidation Protein Products)		1 month	No
Primary	neutrophil gelatinase-associated lipocalin (NGAL),		1 month	No
Secondary	Haptoglobin		1 month	No