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Long Term Outcome of Congenital Solitary Kidney (CSKP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Italy: Ethics Committee

Keywords provided by 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 February 27, 2015