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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02917070
Other study ID # 2016/257
Secondary ID 301
Status Completed
Phase N/A
First received September 9, 2016
Last updated September 26, 2016
Start date February 2016
Est. completion date August 2016

Study information

Verified date September 2016
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational [Patient Registry]

Clinical Trial Summary

Inbreeding and consanguineous marriages are known to increase the risk of autosomal recessive disorders. The aim of this study was to examine the association between consanguinity and kidney diseases in the adult Turkish population.


Description:

This was a national, cross-sectional study recruiting patients from nephrology out-patient clinics and dialysis units. All patients between 18 and 70 years of age who were on follow up in outpatient clinic and dialysis unit at the Istanbul Medical Faculty from October 2009 to October 2015 were included in the study. All patients and healthy controls enrolled in this study gave informed consent to participate in the survey. They were all asked to answer a questionnaire including socio-demographic data, history of familial kidney disease and consanguineous marriage. Additional information was obtained from their private physicians and medical files. To ensure reliability of administration of the questionnaire, all interviewers underwent training using a standardized protocol.


Recruitment information / eligibility

Status Completed
Enrollment 2576
Est. completion date August 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- follow up in outpatient clinic and dialysis unit at the Istanbul Medical Faculty

- between 18-70 years old

- provide informed consent

Exclusion Criteria:

- follow-up shorter than 6 months

- patients whose data were not available

- patients who were unwilling or unable to provide informed consent

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Intervention

Other:
Patients
In this study we aimed to investigate effect of family history and consanguineous marriage in the development of CKD in the adult Turkish population.

Locations

Country Name City State
Turkey Istanbul University, Istanbul Faculty of Medicine Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Chronic Kidney Disease Prognosis Consortium, Matsushita K, van der Velde M, Astor BC, Woodward M, Levey AS, de Jong PE, Coresh J, Gansevoort RT. Association of estimated glomerular filtration rate and albuminuria with all-cause and cardiovascular mortalit — View Citation

Gumprecht J, Zychma MJ, Grzeszczak W, Zukowska-Szczechowska E; End-stage Renal Disease Study Group. Human SA gene Pst1 polymorphism and chronic renal failure: results of the family-based study. Nephrol Dial Transplant. 2001 Feb;16(2):387-90. — View Citation

National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. — View Citation

O'Dea DF, Murphy SW, Hefferton D, Parfrey PS. Higher risk for renal failure in first-degree relatives of white patients with end-stage renal disease: a population-based study. Am J Kidney Dis. 1998 Nov;32(5):794-801. — View Citation

Süleymanlar G, Utas C, Arinsoy T, Ates K, Altun B, Altiparmak MR, Ecder T, Yilmaz ME, Çamsari T, Basçi A, Odabas AR, Serdengeçti K. A population-based survey of Chronic REnal Disease In Turkey--the CREDIT study. Nephrol Dial Transplant. 2011 Jun;26(6):186 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of parental consanguinity on chronic kidney disease confirmed by a questionnaire did they have consanguinity marriage or not. 6 months after enrollment No
Secondary Effect of family history of kidney disease on the development of chronic kidney confirmed by a questionnaire did they have any parents with chronic kidney diseases or not. 6 months after enrollment No
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