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INSIGHT (Insight Into Nephrotic Syndrome) (INSIGHT)

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ClinicalTrials.gov Identifier: NCT01605266
Recruitment Status : Recruiting
First Posted : May 24, 2012
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Rulan Parekh, The Hospital for Sick Children

Brief Summary:
INSIGHT is a longitudinal study of childhood nephrotic syndrome to determine genetic, serologic and environmental factors contributing to nephrotic syndrome and disease progression.

Condition or disease
Nephrotic Syndrome

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.

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: INSIGHT (Insight Into Nephrotic Syndrome: Investigating Genes, Health and Therapeutics)
Study Start Date : January 2011
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Group/Cohort
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.



Primary Outcome Measures :
  1. Relapse (number of relapses) [ Time Frame: Entire follow-up ]
    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 :
  1. Frequently relapsing NS (yes or no) [ Time Frame: 6, 12, 18 and 24 months ]
    4 or more relapses within any 12 month interval OR 2 or more relapses within the first 6 months since diagnosis

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

  3. Initial Steroid Resistance (yes or no) [ Time Frame: Up to 16 weeks ]
    Commencing second line medication due to no response from prednisone with initial treatment

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

  5. ESRD (yes or no) [ Time Frame: Entire follow-up ]
    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.


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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

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): 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: Diane Hebert, MD         
Sub-Investigator: Christoph Licht, MD         
Hamilton Health Sciences Corporation - McMaster University Medical Centre Recruiting
Hamilton, Ontario, Canada, L8L 8E7
Contact: Rahul Chanchlani, MD         
Principal Investigator: Rahul Chanchlani, MD, MSc         
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: 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: Lisa Strug, MD         
Sub-Investigator: Christoph Licht, MD         
Sub-Investigator: Valerie Langlois, MD         
Sub-Investigator: Damien Noone, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Rulan Parekh, MD The Hospital for Sick Children

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Rulan Parekh, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01605266     History of Changes
Other Study ID Numbers: 1000021384
First Posted: May 24, 2012    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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