INSIGHT (Insight Into Nephrotic Syndrome)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Rulan Parekh, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01605266
First received: April 20, 2012
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

INSIGHT is a longitudinal study of children with nephrotic syndrome to determine genetic, serologic and environmental factors contributing to nephrotic syndrome and disease progression.


Condition
Nephrotic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: INSIGHT (Insight Into Nephrotic Syndrome: Investigating Genes, Health and Therapeutics)

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Remission (yes/no) [ Time Frame: at 4 months ] [ Designated as safety issue: No ]
    Urine protein/creatinine <0.2 or Albustik negative or trace for 3 consecutive days

  • Remission (yes/no) [ Time Frame: at 8 months ] [ Designated as safety issue: No ]
    Urine protein/creatinine <0.2 or Albustik negative or trace for 3 consecutive days

  • Remission (yes/no) [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Urine protein/creatinine <0.2 or Albustik negative or trace for 3 consecutive days

  • Remission (yes/no) [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    Urine protein/creatinine <0.2 or Albustik negative or trace for 3 consecutive days

  • Remission (yes/no) [ Time Frame: at 60 months ] [ Designated as safety issue: No ]
    Urine protein/creatinine <0.2 or Albustik negative or trace for 3 consecutive days


Secondary Outcome Measures:
  • Relapse (number of relapses) [ Time Frame: at months 2, 4, 8, 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
    After remission, an increase in the first AM morning urine protein/creatinine ≥2 for 3 of 5 consecutive days

  • Frequently relapsing NS (yes or no) [ Time Frame: 2, 4, 8, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    4 or more relapses within 1 year OR 2 or more relapses within 6 months

  • Steroid - dependant NS (yes or no) [ Time Frame: 4, 8, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Relapse during steroid taper or within 14 days of steroid discontinuation

  • Steroid Resistant(yes or no) [ Time Frame: 12, 24, 36 months ] [ Designated as safety issue: No ]
    Inability to induce remission within 28 days of steroid therapy

  • Urine protein/creatinine [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Abnormal if >250 mg/mmol

  • Urine albumin/creatine [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Abnormal if > 30mg/mol

  • Creatinine based estimated glomerular filtration rate (eGFR) [ Time Frame: 12, 24, 36 and 48 months ] [ Designated as safety issue: No ]
    Abnormal if <60 ml/min/1.73m2

  • CKD/ESRD (yes or no) [ Time Frame: Over 60 months ] [ Designated as safety issue: No ]
    eGFR<60 ml/min/1.73m2 (or dialysis)


Biospecimen Retention:   Samples With DNA

Blood will be drawn for DNA, serum, plasma, buffy coat and whole blood.


Estimated Enrollment: 1000
Study Start Date: January 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Nephrotic Syndrome
The cohort will include all children diagnosed with nephrotic syndrome between age 1-18. Children and their caregiver must be willing to provide informed consent, complete questionnaires, and provide biospecimens of the child. Those with secondary causes of nephrotic syndrome and/or systemic disease are excluded.

Detailed Description:

INSIGHT is a longitudinal observational study of children with nephrotic syndrome to determine genetic, serologic and environmental factors contributing to nephrotic syndrome and disease progression. This will be a large multiethnic cohort to test hypotheses of gene and environmental risk factors and disease progression. Participants will be recruited from Toronto and surrounding region. Additional sites will be added on in the future.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children with nephrotic syndrome. Children will initially be recruited from Toronto and surrounding region with additional sites added later.

Criteria

Inclusion Criteria:

  1. diagnosis of nephrotic syndrome
  2. signed informed consent and assent appropriate for age
  3. ages 1-18 years old and
  4. ability to complete questionnaires

Exclusion Criteria:

  1. congenital nephrotic syndrome (less than age 1)
  2. syndromic disease with multiple organ involvement
  3. inability to provide consent by primary care providers
  4. conditions such as systemic lupus erythematous.
  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: NCT01605266

Contacts
Contact: Rulan Parekh, MD 416-813-7654 ext 2804 rulan.parekh@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5V1X8
Principal Investigator: Rulan Parekh, MD         
Sub-Investigator: Diane Hebert, MD         
Sub-Investigator: Tino Piscione, MD         
Sub-Investigator: Lisa Strug, MD         
Sub-Investigator: Christopher Licht, MD         
Sub-Investigator: Vivian Cornelius         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Rulan Parekh, MD The Hospital for Sick Children
  More Information

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rulan Parekh, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01605266     History of Changes
Other Study ID Numbers: 1000021384
Study First Received: April 20, 2012
Last Updated: August 15, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
pediatric
kidney disease

Additional relevant MeSH terms:
Nephrotic Syndrome
Syndrome
Disease
Kidney Diseases
Nephrosis
Pathologic Processes
Urologic Diseases

ClinicalTrials.gov processed this record on October 21, 2014