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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2032

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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