NCT02917070

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,576

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

3 months

First QC Date

September 9, 2016

Last Update Submit

September 26, 2016

Conditions

Keywords

Consanguinity-associated kidney diseasesTurkey population

Outcome Measures

Primary Outcomes (1)

  • Effect of parental consanguinity on chronic kidney disease confirmed by a questionnaire did they have consanguinity marriage or not.

    6 months after enrollment

Secondary Outcomes (1)

  • 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

Study Arms (2)

Patients

Patients who have chronic kidney diseases

Other: Patients

Healthy controls

Healthy subjects

Interventions

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

Also known as: Inbreeding marriage
Patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • follow up in outpatient clinic and dialysis unit at the Istanbul Medical Faculty
  • between 18-70 years old
  • provide informed consent

You may not qualify if:

  • follow-up shorter than 6 months
  • patients whose data were not available
  • patients who were unwilling or unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, 34030, Turkey (Türkiye)

Location

Related Publications (5)

  • 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. No abstract available.

  • 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 mortality in general population cohorts: a collaborative meta-analysis. Lancet. 2010 Jun 12;375(9731):2073-81. doi: 10.1016/S0140-6736(10)60674-5. Epub 2010 May 17.

  • Suleymanlar G, Utas C, Arinsoy T, Ates K, Altun B, Altiparmak MR, Ecder T, Yilmaz ME, Camsari T, Basci A, Odabas AR, Serdengecti K. A population-based survey of Chronic REnal Disease In Turkey--the CREDIT study. Nephrol Dial Transplant. 2011 Jun;26(6):1862-71. doi: 10.1093/ndt/gfq656. Epub 2010 Nov 4.

  • 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. doi: 10.1093/ndt/16.2.387.

  • 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. doi: 10.1016/s0272-6386(98)70135-0.

MeSH Terms

Conditions

Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Yasar Caliskan, Dr.

    Istanbul University, Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Nephrology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 28, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

September 28, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations