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Cystatin c and Beta 2 Microglobulin in Thalassemic Children.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03881917
Recruitment Status : Not yet recruiting
First Posted : March 20, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Naguib Khairy, Assiut University

Brief Summary:
Beta thalassemia has many complications on many systems as the renal system.So early detection of renal impairment is required in those children to decrease complications of this nephropathy.

Condition or disease Intervention/treatment
Blood Disease Diagnostic Test: Cystatin c and beta 2 microglobulin kits

Detailed Description:
Thalassemia syndromes are the most common single gene disorders worldwide especially in developing countries. The use of regular and frequent blood transfusions in patients with beta thalassemia major has improved patients' life spans and quality of life, but can lead to chronic iron overload. Many factors contribute to the functional abnormalities found in beta thalassemia patients such as decreased red cell life span, rapid iron turnover, tissue deposition of excess iron and also, specific iron chelators can affect kidneys. The success in management of patients of beta thalassemia has led to chronic hemosiderosis in different organs like liver and heart and long-term complications in other organs like pancreas and kidneys have recently been studied. The evidence of proximal tubular damage has been observed in beta thalassemia patients. Also, low-molecular-weight proteinuria has been found in almost all patients. Unlike other organs, it is unclear whether kidney damage results solely from intravascular haemolysis, chronic transfusion or as a complication of iron chelation therapy. Although the early identification of patients at high risk of renal impairment is of great importance as it may allow specific measures to be taken to delay renal impairment, there are limited studies about renal dysfunction in pediatric thalassemic patients. Thus, in this study we will use different measurements for early detection of renal impairment even if the patients have no symptoms to handle with the disease in its reversible stage before being irreversible. Beside the usual investigations of renal function we will measure cystatin c and beta2 microglobulin as early markers of renal impairment.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cystatin C and Beta 2 Microglobulin as Biochemical Markers for Early Detection of Renal Impairment in Children With Beta Thalassemia
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia


Intervention Details:
  • Diagnostic Test: Cystatin c and beta 2 microglobulin kits
    Kits for measurement concentration


Primary Outcome Measures :
  1. mean difference of cystatin c and beta 2 microglobulin concentrations with normal range [ Time Frame: baseline ]
    Analysis of the results to differentiate the affected from non affected patients



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children with beta thalassemia from the age of 1 year to 18 years.
Criteria

Inclusion Criteria:

  • Children with beta thalassemia from the age of 1 year to 18 years.

Exclusion Criteria:

  • Children who have other hematological or chronic disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881917


Contacts
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Contact: Mohamed Naguib Khairy, M.B.B.Ch +201091921973 mohamed_ibrahim@med.au.edu.eg

Sponsors and Collaborators
Assiut University
Publications of Results:

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Responsible Party: Mohamed Naguib Khairy, Principle Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03881917    
Other Study ID Numbers: Renal markers in thalassemia.
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Naguib Khairy, Assiut University:
renal impairment
Additional relevant MeSH terms:
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Hematologic Diseases
Cystatins
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action