INSIGHT (Insight Into Nephrotic Syndrome)

Nephrotic Syndrome Clinical Trial

— INSIGHT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01605266
• Other study ID #: 1000021384
• Status: Recruiting
• Start date: January 2011
• Est. completion date: January 2032

Study information

• Verified date: October 2022
• Source: The Hospital for Sick Children
• Contact: Rulan Parekh, MD
• Phone: 416-813-7654
• Email: rulan.parekh[@]sickkids.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2032
• Est. primary completion date: January 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Syndrome

Locations

Country	Name	City	State
Canada	William Osler Health System, Brampton Civic Hospital and Peel Memorial Centre for Integrated Health and Wellness	Brampton	Ontario
Canada	Hamilton Health Sciences Corporation - McMaster University Medical Centre	Hamilton	Ontario
Canada	Rouge Valley Health System, Rouge Valley Centenary	Scarborough	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Banh TH, Hussain-Shamsy N, Patel V, Vasilevska-Ristovska J, Borges K, Sibbald C, Lipszyc D, Brooke J, Geary D, Langlois V, Reddon M, Pearl R, Levin L, Piekut M, Licht CP, Radhakrishnan S, Aitken-Menezes K, Harvey E, Hebert D, Piscione TD, Parekh RS. Ethni — View Citation

Borges K, Sibbald C, Hussain-Shamsy N, Vasilevska-Ristovska J, Banh T, Patel V, Brooke J, Piekut M, Reddon M, Aitken-Menezes K, McNaughton A, Pearl RJ, Langlois V, Radhakrishnan S, Licht CPB, Piscione TD, Levin L, Noone D, Hebert D, Parekh RS. Parental He — View Citation

Borges K, Vasilevska-Ristovska J, Hussain-Shamsy N, Patel V, Banh T, Hebert D, Pearl RJ, Radhakrishnan S, Piscione TD, Licht CP, Langlois V, Levin L, Strug L, Parekh RS. Parental attitudes to genetic testing differ by ethnicity and immigration in childhoo — View Citation

Hussain N, Zello JA, Vasilevska-Ristovska J, Banh TM, Patel VP, Patel P, Battiston CD, Hebert D, Licht CP, Piscione TD, Parekh RS. The rationale and design of Insight into Nephrotic Syndrome: Investigating Genes, Health and Therapeutics (INSIGHT): a prospective cohort study of childhood nephrotic syndrome. BMC Nephrol. 2013 Jan 26;14:25. doi: 10.1186/1471-2369-14-25. — View Citation

Konstantelos N, Banh T, Patel V, Vasilevska-Ristovska J, Borges K, Hussain-Shamsy N, Noone D, Hebert D, Radhakrishnan S, Licht CPB, Langlois V, Pearl RJ, Parekh RS. Association of low birth weight and prematurity with clinical outcomes of childhood nephro — View Citation

Riar SS, Banh THM, Borges K, Subbarao P, Patel V, Vasilevska-Ristovska J, Chanchlani R, Hussain-Shamsy N, Noone D, Hebert D, Licht CPB, Langlois V, Pearl RJ, Parekh RS. Prevalence of Asthma and Allergies and Risk of Relapse in Childhood Nephrotic Syndrome — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse (number of relapses)	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	Frequently relapsing NS (yes or no)	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
Secondary	Steroid - dependent NS (yes or no)	2 relapses during steroid taper or a relapse within 14 days of steroid discontinuation	6, 12, 18 and 24 months
Secondary	Initial Steroid Resistance (yes or no)	Commencing second line medication due to no response from prednisone with initial treatment	Up to 16 weeks
Secondary	CKD (yes or no)	eGFR less than or equal to 60mg/ml/1.73m^2 for 3 or more consecutive months	Entire follow-up
Secondary	ESRD (yes or no)	eGFR less than or equal to 15 mg/ml/1.73m^2, or initiation of dialysis or receiving a transplant.	Entire follow-up

External Links

•   PubMed: The rationale and design of Insight into Nephrotic Syndrome: Investigating Genes, Health and Therapeutics (INSIGHT): a prospective cohort study of childhood nephrotic syndrome.