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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
Sponsor:
Information provided by (Responsible Party):
Giovanni Montini, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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
Congenital Solitary Kidney

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Study Design
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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
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Hypertension [ Time Frame: 10 years ]
    Hypertension defined by the National High Blood Pressure Education Program Working Group as a blood pressure ≥ 95th percentile


Eligibility Criteria
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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
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:

  1. Age 0 to 18 years
  2. Congenital Solitary Kidney
  3. Male and female sex
  4. 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:

  1. Age > 18 years
  2. Chronic renal failure
  3. Posterior urethral valves
  4. Diabetes
  5. Heart and/or vascular diseases
  6. Autoimmune diseases
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
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