Cystatin c and Beta 2 Microglobulin in Thalassemic Children.

Blood Disease Clinical Trial

Official title:

Cystatin C and Beta 2 Microglobulin as Biochemical Markers for Early Detection of Renal Impairment in Children With Beta Thalassemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03881917
• Other study ID #: Renal markers in thalassemia.
• Status: Not yet recruiting
• Start date: November 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: Mohamed Naguib Khairy, M.B.B.Ch
• Phone: +201091921973
• Email: mohamed_ibrahim[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Disease
• Hematologic Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (9)

Ali BA, Mahmoud AM. Frequency of glomerular dysfunction in children with Beta thalassaemia major. Sultan Qaboos Univ Med J. 2014 Feb;14(1):e88-94. Epub 2014 Jan 27. — View Citation

Annayev A, Karakas Z, Karaman S, Yalçiner A, Yilmaz A, Emre S. Glomerular and Tubular Functions in Children and Adults with Transfusion-Dependent Thalassemia. Turk J Haematol. 2018 Mar 1;35(1):66-70. doi: 10.4274/tjh.2017.0266. Epub 2017 Jul 28. — View Citation

Bakr A, Al-Tonbary Y, Osman G, El-Ashry R. Renal complications of beta-thalassemia major in children. Am J Blood Res. 2014 Sep 5;4(1):1-6. eCollection 2014. Review. — View Citation

Behairy OG, Abd Almonaem ER, Abed NT, Abdel Haiea OM, Zakaria RM, AbdEllaty RI, Asr EH, Mansour AI, Abdelrahman AM, Elhady HA. Role of serum cystatin-C and beta-2 microglobulin as early markers of renal dysfunction in children with beta thalassemia major. — View Citation

den Bakker E, Gemke RJBJ, Bökenkamp A. Endogenous markers for kidney function in children: a review. Crit Rev Clin Lab Sci. 2018 May;55(3):163-183. doi: 10.1080/10408363.2018.1427041. Epub 2018 Feb 1. Review. — View Citation

Deveci B, Kurtoglu A, Kurtoglu E, Salim O, Toptas T. Documentation of renal glomerular and tubular impairment and glomerular hyperfiltration in multitransfused patients with beta thalassemia. Ann Hematol. 2016 Feb;95(3):375-81. doi: 10.1007/s00277-015-256 — View Citation

Hashemieh M, Radfar M, Azarkeivan A, Hosseini Tabatabaei SMT, Nikbakht S, Yaseri M, Sheibani K. Renal Hemosiderosis among Iranian Transfusion Dependent ß-Thalassemia Major Patients. Int J Hematol Oncol Stem Cell Res. 2017 Apr 1;11(2):133-138. — View Citation

Nickavar A, Qmarsi A, Ansari S, Zarei E. Kidney Function in Patients With Different Variants of Beta-Thalassemia. Iran J Kidney Dis. 2017 Mar;11(2):132-137. — View Citation

Uzun E, Balci YI, Yüksel S, Aral YZ, Aybek H, Akdag B. Glomerular and tubular functions in children with different forms of beta thalassemia. Ren Fail. 2015;37(9):1414-8. doi: 10.3109/0886022X.2015.1077314. Epub 2015 Sep 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean difference of cystatin c and beta 2 microglobulin concentrations with normal range	Analysis of the results to differentiate the affected from non affected patients	baseline