AnemiaNCT02312414
Effects of Carnitine on Oxidative Stress to IVIR Administration to CKD Patients:Impact of Haptoglobin Genotype
A study testing L-Canitine in people with Anemia, run by The Nazareth Hospital, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anemia
- What is being tested?
- L-Canitine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Nazareth hospital (EMMS)
Nazareth
Zaher Armaly, MD, zaherarmaly@nazhosp.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Anemia
- Being tested
- L-Canitine
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CanitineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: L-Canitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOPP (Advanced Oxidation Protein Products)
Measured: 1 month
neutrophil gelatinase-associated lipocalin (NGAL),
Measured: 1 month
Secondary outcomes (1)
Haptoglobin
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Nazareth Hospital, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zaher armaly, Nazareth Hospital
- Investigators
- Amir Abd El Qader, Ph.D, Study director, Nazareth EMMS Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312414
- Sponsor's protocol ID
- 5700858
- Status last verified
- May 2015
- First submitted
- 5 Dec 2014
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26268514
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Carnitine on Oxidative Stress and Inflammatory Responses to Intravenous Iron Administration to Patients With CKD: Impact of Haptoglobin Genotype
- ClinicalTrials.gov ID
- NCT02312414
- Acronym / sponsor ID
- 5700858
- Conditions
- Anemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The Nazareth Hospital, IsraelUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVIR | No intervention | –Patients given IV iron (Sodium ferric gluconate, [125 mg/100 ml] from week 1 to week 4 |
| IVIR Carnitine | Experimental | Drug: L-CanitinePatients given Carnitine (20mg/kg, IV) perior to IV iron (Sodium ferric gluconate, [125 mg/100 ml] from week 4 to week 8. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Pregnant women.
- Patient with CKD stage 5 on Dialysis.
- Patients with severe liver diseases.
- Patients with severe CHF.
- Inter-current illness such as fever.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-CanitineCarnitine 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 | Drug | IVIR Carnitine |
Primary outcome
AOPP (Advanced Oxidation Protein Products)
Time frame: 1 month
neutrophil gelatinase-associated lipocalin (NGAL),
Time frame: 1 month
1 secondary outcome
Haptoglobin
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
- Derived from this study: PubMed 26268514Armaly 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Abd El Qader, Ph.D study director
Nazareth EMMS Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Canitine in people with Anemia, run by The Nazareth Hospital, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zaher Armaly, M.D. (+972546693498, zaherarmaly@nazhosp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AOPP (Advanced Oxidation Protein Products) (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02312414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2015.