Clinical trial NCT03881917: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Disease
Keywords: renal impairment
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with beta thalassemia from the age of 1 year to 18 years.

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.

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.

Primary outcomes:
measure: mean difference of cystatin c and beta 2 microglobulin concentrations with normal range
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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