Long Term Outcome of Congenital Solitary Kidney (CSKP)
Recruitment status was: Recruiting
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.
Congenital Solitary Kidney
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Renal Outcome in Children With Congenital Solitary Kidney: a Longitudinal Prognostic Study|
- Chronic kidney disease [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]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.
- Proteinuria [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Hypertension defined by the National High Blood Pressure Education Program Working Group as a blood pressure ≥ 95th percentile
|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)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01831141
|Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi,|
|Bologna, Emilia Romagna, Italy, 40100|
|Study Chair:||Giovanni Montini, MD||Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi, Bologna, Italy|