Ignite Creation Date:
2024-05-06 @ 3:32 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02312414
Status:
UNKNOWN
Last Update Posted:
2015-05-18
First Post:
2014-12-05
Brief Title:
Effects of Carnitine on Oxidative Stress to IVIR Administration to CKD PatientsImpact of Haptoglobin Genotype
Sponsor:
The Nazareth Hospital Israel
Organization:
The Nazareth Hospital Israel
Study Overview
Official Title:
Effects of Carnitine on Oxidative Stress and Inflammatory Responses to Intravenous Iron Administration to Patients With CKD Impact of Haptoglobin Genotype
Status:
UNKNOWN
Status Verified Date:
2015-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 HemoglobinIron 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
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 mg100 ml for 8 weeks and during weeks 5-8 also received Carnitine 20mgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None