NCT03881917

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 18, 2019

Last Update Submit

March 18, 2019

Conditions

Blood Disease

Keywords

renal impairment

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Cystatin c and beta 2 microglobulin kitsDIAGNOSTIC_TEST

Kits for measurement concentration

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Children who have other hematological or chronic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • den Bakker E, Gemke RJBJ, Bokenkamp 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.

    PMID: 29388463RESULT

  • Annayev A, Karakas Z, Karaman S, Yalciner 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.

    PMID: 28753129RESULT

  • 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. Int J Nephrol Renovasc Dis. 2017 Sep 11;10:261-268. doi: 10.2147/IJNRD.S142824. eCollection 2017.

    PMID: 28979155RESULT

  • 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/s00277-015-2561-2. Epub 2015 Nov 23.

    PMID: 26596972RESULT

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

    PMID: 28875008RESULT

  • 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. doi: 10.12816/0003341. Epub 2014 Jan 27.

    PMID: 24516760RESULT

  • 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.

    PMID: 25232499RESULT

  • Uzun E, Balci YI, Yuksel 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.

    PMID: 26365703RESULT

  • 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.

    PMID: 28270645RESULT

MeSH Terms

Conditions

Hematologic DiseasesRenal Insufficiency

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Mohamed Naguib Khairy, M.B.B.Ch

CONTACT

+201091921973mohamed_ibrahim@med.au.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 20, 2019

Study Start

November 1, 2019

Primary Completion

November 1, 2020

Study Completion

March 1, 2021

Last Updated

March 20, 2019

Record last verified: 2019-03