Long Term Outcome of Congenital Solitary Kidney (CSKP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified April 2013 by Giovanni Montini, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Giovanni Montini, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

ClinicalTrials.gov Identifier:

NCT01831141

First received: April 11, 2013

Last updated: NA

Last verified: April 2013

History: No changes posted

Purpose

Congenital solitary kidney (CSK) is a disorder caused by an abnormal development of one of the two kidneys. The reported incidence ranges between 1:450-3200. It is debated whether CSK is a benign condition or not. A variable risk of developing proteinuria (11-27%), hypertension (0-60%) and chronic kidney damage (3.5-30%) is described. This knowledge derives mainly from retrospective studies performed in tertiary medical centers which is difficult to compare for the following reasons: the number of individuals evaluated, the length of follow-up and the outcome studied.

The aim of this longitudinal study is to assess, in a cohort of children with congenital solitary kidney, during a 10 year follow-up period: 1) the rates of developing proteinuria, hypertension and chronic kidney disease and the corresponding potential prognostic factors. 2) the role of new biomarkers of glomerular (Cystatin C) or tubular damage (NGAL, NAG, B2-microglobulin) in predicting the appearance of chronic kidney damage.

Condition
Congenital Solitary Kidney


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Renal Outcome in Children With Congenital Solitary Kidney: a Longitudinal Prognostic Study

Further study details as provided by Giovanni Montini, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:

Primary Outcome Measures:

Chronic kidney disease [ Time Frame: 10 years ]
Chronic kidney disease defined by National Kidney Foundation's Kidney Disease Outcomes Quality Initiative clinical practice guidelines for chronic kidney disease in children and adolescents with a glomerular filtration rate less than 89 ml/min/1.73 m2.

Secondary Outcome Measures:

Proteinuria [ Time Frame: 10 years ]
Proteinuria defined by the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative as a urine protein/urine creatinine ratio of more than 0.5 in children younger six months and of more than 0.2 in older children.
Hypertension [ Time Frame: 10 years ]
Hypertension defined by the National High Blood Pressure Education Program Working Group as a blood pressure ≥ 95th percentile


Estimated Enrollment:	120
Study Start Date:	June 2010
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility


Ages Eligible for Study:	up to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Children aged 0 - 18 years, diagnosed with a CSK (defined as a single functioning kidney documented and confirmed by DMSA Scan.).

Subjects will be enrolled from 1st June 2010 to 30th Jume 2013 at the Paediatric Nephrology Department of the Sant'Orsola Malpighi Hospital, the follow-up of each subject will continue for 10 years.

Criteria

Inclusion Criteria:

Age 0 to 18 years
Congenital Solitary Kidney
Male and female sex
Written Informed consent will be obtained

Children with chronic renal failure, posterior urethral valves, diabetes, heart and/or vascular diseases and autoimmune diseases will be excluded. Subjects will be enrolled at the

Exclusion Criteria:

Age > 18 years
Chronic renal failure
Posterior urethral valves
Diabetes
Heart and/or vascular diseases
Autoimmune diseases

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01831141

Contacts


Contact: Giovanni Montini, MD	+390516364617	giovanni.montini@aosp.bo.it
Contact: Claudio La Scola, MD	+393200864458	clasc1976@gmail.com

Locations


Italy
Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi,	Recruiting
Bologna, Emilia Romagna, Italy, 40100

Sponsors and Collaborators

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Investigators


Study Chair:	Giovanni Montini, MD	Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi, Bologna, Italy

More Information


Responsible Party:	Giovanni Montini, MD, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:	NCT01831141 History of Changes
Other Study ID Numbers:	CSKP
Study First Received:	April 11, 2013
Last Updated:	April 11, 2013

Keywords provided by Giovanni Montini, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:


Congenital Solitary Kidney Glomerular filtration rate Chronic kidney damage Hypertension Proteinuria

Additional relevant MeSH terms:


Urogenital Abnormalities Congenital Abnormalities

ClinicalTrials.gov processed this record on June 28, 2017

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