Long Term Outcome of Congenital Solitary Kidney (CSKP)
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ClinicalTrials.gov Identifier: NCT01831141 |
Recruitment Status
: Unknown
Verified April 2013 by Giovanni Montini, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.
Recruitment status was: Recruiting
First Posted
: April 15, 2013
Last Update Posted
: April 15, 2013
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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 or disease |
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Congenital Solitary Kidney |

Study Type : | Observational |
Estimated Enrollment : | 120 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Renal Outcome in Children With Congenital Solitary Kidney: a Longitudinal Prognostic Study |
Study Start Date : | June 2010 |
Estimated Primary Completion Date : | June 2013 |
Estimated Study Completion Date : | June 2013 |
- 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.
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831141
Contact: Giovanni Montini, MD | +390516364617 | giovanni.montini@aosp.bo.it | |
Contact: Claudio La Scola, MD | +393200864458 | clasc1976@gmail.com |
Italy | |
Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi, | Recruiting |
Bologna, Emilia Romagna, Italy, 40100 |
Study Chair: | Giovanni Montini, MD | Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi, Bologna, Italy |
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 |
First Posted: | April 15, 2013 Key Record Dates |
Last Update Posted: | April 15, 2013 |
Last Verified: | April 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 |