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

NCT02312414 | Unknown DMC

• 1 other identifier: 5700858
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (2)

• AOPP (Advanced Oxidation Protein Products)

  1 month

• neutrophil gelatinase-associated lipocalin (NGAL),

  1 month

Secondary Outcomes (1)

• Haptoglobin

  1 month

Study Arms (2)

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.

Drug: L-Canitine

Interventions

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

IVIR Carnitine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that have been diagnosed as suffering from chronic kidney diseases at stages 3-4 and confirmed by MDRD.
• CKD patients with Hb of less than 10 g%.
• At age ≥18 y.

You may not qualify if:

• Pregnant women.
• Patient with CKD stage 5 on Dialysis.
• Patients with severe liver diseases.
• Patients with severe CHF.
• Inter-current illness such as fever.
• Allergic rhinitis.

Sponsors & Collaborators

• The Nazareth Hospital, Israel: lead

Study Sites (1)

Nazareth hospital (EMMS)

Nazareth, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 26268514 DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Amir Abd El Qader, Ph.D

  Nazareth EMMS Hospital

  STUDY DIRECTOR

Central Study Contacts

Zaher Armaly, M.D.

CONTACT

+972546693498; zaherarmaly@nazhosp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Zaher Armaly, Head of Nephrology and Hypertension Department Nazareth Hospital- EMMS

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 9, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Last Updated: May 18, 2015

Record last verified: 2015-05

Locations

IL (1)