Clinical Trial: INSIGHT (Insight Into Nephrotic Syndrome)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: INSIGHT (Insight Into Nephrotic Syndrome: Investigating Genes, Health and Therapeutics)

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.

Detailed Summary: 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.
Sponsor: The Hospital for Sick Children

Current Primary Outcome: 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


Original Primary Outcome:

  • Remission (yes/no) [ Time Frame: at 4 months ]
    Urine protein/creatinine <0.2 or Albustik negative or trace for 3 consecutive days
  • Remission (yes/no) [ Time Frame: at 8 months ]
    Urine protein/creatinine <0.2 or Albustik negative or trace for 3 consecutive days
  • Remission (yes/no) [ Time Frame: at 12 months ]
    Urine protein/creatinine <0.2 or Albustik negative or trace for 3 consecutive days
  • Remission (yes/no) [ Time Frame: at 24 months ]
    Urine protein/creatinine <0.2 or Albustik negative or trace for 3 consecutive days
  • Remission (yes/no) [ Time Frame: at 60 months ]
    Urine protein/creatinine <0.2 or Albustik negative or trace for 3 consecutive days


Current Secondary Outcome:

  • 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
  • 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
  • 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
  • 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
  • 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.


Original Secondary Outcome:

  • Relapse (number of relapses) [ Time Frame: at months 2, 4, 8, 12, 24, 36, 48 and 60 ]
    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 ]
    4 or more relapses within 1 year OR 2 or more relapses within 6 months
  • Steroid - dependent NS (yes or no) [ Time Frame: 4, 8, 12, 24, 36, 48 and 60 months ]
    Relapse during steroid taper or within 14 days of steroid discontinuation
  • Steroid Resistant(yes or no) [ Time Frame: 12, 24, 36 months ]
    Inability to induce remission within 28 days of steroid therapy
  • Urine protein/creatinine [ Time Frame: 12, 24 and 36 months ]
    Abnormal if >250 mg/mmol
  • Urine albumin/creatine [ Time Frame: 12, 24 and 36 months ]
    Abnormal if > 30mg/mol
  • Creatinine based estimated glomerular filtration rate (eGFR) [ Time Frame: 12, 24, 36 and 48 months ]
    Abnormal if <60 ml/min/1.73m2
  • CKD/ESRD (yes or no) [ Time Frame: Over 60 months ]
    eGFR<60 ml/min/1.73m2 (or dialysis)


Information By: The Hospital for Sick Children

Dates:
Date Received: April 20, 2012
Date Started: January 2011
Date Completion: January 2021
Last Updated: February 1, 2017
Last Verified: February 2017