INSIGHT (Insight Into Nephrotic Syndrome) (INSIGHT)

October 24, 2022 updated by: Rulan Parekh, The Hospital for Sick Children

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

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

Study Overview

Status

Recruiting

Conditions

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

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Recruiting
        • William Osler Health System, Brampton Civic Hospital and Peel Memorial Centre for Integrated Health and Wellness
        • Principal Investigator:
          • Rachel J Pearl, MD
        • Sub-Investigator:
          • Rulan Parekh, MD
        • Sub-Investigator:
          • Diane Hebert, MD
        • Sub-Investigator:
          • Christoph Licht, MD
      • Hamilton, Ontario, Canada, L8L 8E7
        • Recruiting
        • Hamilton Health Sciences Corporation - McMaster University Medical Centre
        • Contact:
          • Rahul Chanchlani, MD
        • Principal Investigator:
          • Rahul Chanchlani, MD, MSc
      • Scarborough, Ontario, Canada, M1E 4B9
        • Recruiting
        • Rouge Valley Health System, Rouge Valley Centenary
        • Sub-Investigator:
          • Rulan Parekh, MD
        • Sub-Investigator:
          • Diane Hebert, MD
        • Sub-Investigator:
          • Christoph Licht, MD
        • Principal Investigator:
          • Hubert Wong, MD
        • Sub-Investigator:
          • Lisa Strug, MD
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • The Hospital for Sick Children
        • Sub-Investigator:
          • Diane Hebert, MD
        • Sub-Investigator:
          • Christoph Licht, MD
        • Sub-Investigator:
          • Lisa Strug, MD
        • Principal Investigator:
          • Rulan Parekh, MD
        • Sub-Investigator:
          • Valerie Langlois, MD
        • Sub-Investigator:
          • Damien Noone, MD
        • Sub-Investigator:
          • Chia Wei Teoh, MD
        • Sub-Investigator:
          • Seetha Radhakrishnan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with nephrotic syndrome. Children are recruited from Toronto and surrounding region with additional sites added later.

Description

Inclusion Criteria:

  1. diagnosis of nephrotic syndrome
  2. signed informed consent and assent appropriate for age
  3. ages 6 months -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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Entire follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6, 12, 18 and 24 months
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
6, 12, 18 and 24 months
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
Up to 16 weeks
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
Entire follow-up
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.
Entire follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ANTICIPATED)

January 1, 2032

Study Completion (ANTICIPATED)

January 1, 2032

Study Registration Dates

First Submitted

April 20, 2012

First Submitted That Met QC Criteria

May 22, 2012

First Posted (ESTIMATE)

May 24, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000021384

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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