Cystatin c and Beta 2 Microglobulin in Thalassemic Children.

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03881917
Collaborator
(none)
150
16

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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
Anticipated Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2020
Anticipated Study Completion Date :
Mar 1, 2021

Outcome Measures

Primary Outcome Measures

  1. mean difference of cystatin c and beta 2 microglobulin concentrations with normal range [baseline]

    Analysis of the results to differentiate the affected from non affected patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Naguib Khairy, Principle Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03881917
Other Study ID Numbers:
  • Renal markers in thalassemia.
First Posted:
Mar 20, 2019
Last Update Posted:
Mar 20, 2019
Last Verified:
Mar 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Naguib Khairy, Principle Investigator, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 20, 2019