Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

INSIGHT (Insight Into Nephrotic Syndrome)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 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: November 18, 2014
Last verified: November 2014
  Purpose

INSIGHT is a longitudinal study of childhood 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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Relapse (number of relapses) [ Time Frame: Entire follow-up ] [ Designated as safety issue: No ]
    After remission, an increase in the first AM morning urine protein ≥ 3+ for 3 consecutive days or increase in maintenance prednisone dose


Secondary Outcome Measures:
  • Frequently relapsing NS (yes or no) [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    4 or more relapses within any 12 month interval OR 2 or more relapses within the first 6 months since diagnosis

  • Steroid - dependent NS (yes or no) [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    2 relapses during steroid taper or a relapse within 14 days of steroid discontinuation

  • Initial Steroid Resistance (yes or no) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    Commencing second line medication due to no response from prednisone with initial treatment

  • CKD (yes or no) [ Time Frame: Entire follow-up ] [ Designated as safety issue: No ]
    eGFR less than or equal to 60mg/ml/1.73m^2 for 3 or more consecutive months

  • ESRD (yes or no) [ Time Frame: Entire follow-up ] [ Designated as safety issue: No ]
    eGFR less than or equal to 15 mg/ml/1.73m^2, or initiation of dialysis or receiving a transplant.


Biospecimen Retention:   Samples With DNA

Blood is drawn for DNA, serum, plasma, buffy coat and whole blood. Urine and toenail clippings are also collected.


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 includes all children diagnosed with nephrotic syndrome between ages 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 childhood nephrotic syndrome to determine genetic, serologic and environmental factors contributing to nephrotic syndrome and disease progression. This is a large multiethnic cohort to test hypotheses of gene and environmental risk factors and disease progression. Participants are recruited from Toronto, Ontario and surrounding regions. 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 are 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 306459 rulan.parekh@sickkids.ca

Locations
Canada, Ontario
William Osler Health System, Brampton Civic Hospital Recruiting
Brampton, Ontario, Canada, L6R 3J7
Principal Investigator: Rachel J Pearl, MD         
Sub-Investigator: Rulan Parekh, MD         
Sub-Investigator: Tino Piscione, MD         
Sub-Investigator: Diane Hebert, MD         
Sub-Investigator: Christoph Licht, MD         
Sub-Investigator: Vivian Cornelius         
Rouge Valley Health System, Rouge Valley Centenary Recruiting
Scarborough, Ontario, Canada, M1E 4B9
Principal Investigator: Hubert Wong, MD         
Sub-Investigator: Rulan Parekh, MD         
Sub-Investigator: Tino Piscione, MD         
Sub-Investigator: Diane Hebert, MD         
Sub-Investigator: Lisa Strug, MD         
Sub-Investigator: Christoph Licht, MD         
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
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         
Sub-Investigator: Valerie Langlois, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Rulan Parekh, MD The Hospital for Sick Children
  More Information

Additional Information:
Publications:
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: November 18, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
pediatric
kidney disease
minimal change disease
focal segmental glomerulosclerosis
nephrotic syndrome

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

ClinicalTrials.gov processed this record on November 20, 2014