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NCT Number: NCT01605266

INSIGHT (Insight Into Nephrotic Syndrome)

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

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Key information

Conditions

Nephrotic Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulosclerosis, Focal Segmental Kidney Diseases Male Urogenital Diseases Nephritis Nephrosis Nephrosis, Lipoid Urogenital Diseases Urologic Diseases

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

William Osler Health System, Brampton Civic Hospital and Peel Memorial Centre for Integrated Health and Wellness, Brampton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of nephrotic syndrome
  • signed informed consent and assent appropriate for age
  • ages 6 months -18 years old and
  • ability to complete questionnaires

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rulan Parekh, MD

CONTACT

[email protected]

416-813-7654 ext. 306459

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Acronym: INSIGHT

Important dates

Study start
2011
Primary completion
2032
Study completion
2032
First posted
May 24, 2012
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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