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Cystatin c and Beta 2 Microglobulin in Thalassemic Children.

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ClinicalTrials.gov Identifier: NCT03881917
Recruitment Status : Unknown
Verified March 2019 by Mohamed Naguib Khairy, Assiut University.
Recruitment status was:  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

Tracking Information
First Submitted Date March 18, 2019
First Posted Date March 20, 2019
Last Update Posted Date March 20, 2019
Estimated Study Start Date November 1, 2019
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 18, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cystatin c and Beta 2 Microglobulin in Thalassemic Children.
Official Title Cystatin C and Beta 2 Microglobulin as Biochemical Markers for Early Detection of Renal Impairment in Children With Beta Thalassemia
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children with beta thalassemia from the age of 1 year to 18 years.
Condition Blood Disease
Intervention Diagnostic Test: Cystatin c and beta 2 microglobulin kits
Kits for measurement concentration
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 18, 2019)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2021
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03881917
Other Study ID Numbers Renal markers in thalassemia.
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Mohamed Naguib Khairy, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date March 2019