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

May 15, 2015 updated by: zaher armaly, The Nazareth Hospital, Israel

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: IVIR
Patients given IV iron (Sodium ferric gluconate, [125 mg/100 ml] from week 1 to week 4
Experimental: IVIR Carnitine
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AOPP (Advanced Oxidation Protein Products)
Time Frame: 1 month
1 month
neutrophil gelatinase-associated lipocalin (NGAL),
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Haptoglobin
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Nazareth Hospital, Israel

Investigators

  • Study Director: Amir Abd El Qader, Ph.D, Nazareth EMMS Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 9, 2014

Study Record Updates

Last Update Posted (Estimate)

May 18, 2015

Last Update Submitted That Met QC Criteria

May 15, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 5700858

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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