Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-01-02 @ 3:40 AM
Study NCT ID:
NCT01605266
Status:
RECRUITING
Last Update Posted:
2022-10-25
First Post:
2012-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INSIGHT (Insight Into Nephrotic Syndrome)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009404', 'term': 'Nephrotic Syndrome'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D009402', 'term': 'Nephrosis, Lipoid'}, {'id': 'D005923', 'term': 'Glomerulosclerosis, Focal Segmental'}], 'ancestors': [{'id': 'D009401', 'term': 'Nephrosis'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood is drawn for DNA, serum, plasma, buffy coat and whole blood. Urine and toenail clippings are also collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2032-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2012-04-20', 'studyFirstSubmitQcDate': '2012-05-22', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2032-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse (number of relapses)', 'timeFrame': 'Entire follow-up', 'description': 'After remission, an increase in the first AM morning urine protein ≥ 3+ for 3 consecutive days or increase in maintenance prednisone dose'}], 'secondaryOutcomes': [{'measure': 'Frequently relapsing NS (yes or no)', 'timeFrame': '6, 12, 18 and 24 months', 'description': '4 or more relapses within any 12 month interval OR 2 or more relapses within the first 6 months since diagnosis'}, {'measure': 'Steroid - dependent NS (yes or no)', 'timeFrame': '6, 12, 18 and 24 months', 'description': '2 relapses during steroid taper or a relapse within 14 days of steroid discontinuation'}, {'measure': 'Initial Steroid Resistance (yes or no)', 'timeFrame': 'Up to 16 weeks', 'description': 'Commencing second line medication due to no response from prednisone with initial treatment'}, {'measure': 'CKD (yes or no)', 'timeFrame': 'Entire follow-up', 'description': 'eGFR less than or equal to 60mg/ml/1.73m\\^2 for 3 or more consecutive months'}, {'measure': 'ESRD (yes or no)', 'timeFrame': 'Entire follow-up', 'description': 'eGFR less than or equal to 15 mg/ml/1.73m\\^2, or initiation of dialysis or receiving a transplant.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatric', 'kidney disease', 'minimal change disease', 'focal segmental glomerulosclerosis', 'nephrotic syndrome'], 'conditions': ['Nephrotic Syndrome']}, 'referencesModule': {'references': [{'pmid': '23351121', 'type': 'BACKGROUND', '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.'}, {'pmid': '26998310', 'type': 'RESULT', '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 childhood nephrotic syndrome: a cross-sectional study. Can J Kidney Health Dis. 2016 Mar 17;3:16. doi: 10.1186/s40697-016-0104-y. eCollection 2016.'}, {'pmid': '27445165', 'type': 'RESULT', 'citation': 'Banh THM, 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 CPB, Radhakrishnan S, Aitken-Menezes K, Harvey E, Hebert D, Piscione TD, Parekh RS. Ethnic Differences in Incidence and Outcomes of Childhood Nephrotic Syndrome. Clin J Am Soc Nephrol. 2016 Oct 7;11(10):1760-1768. doi: 10.2215/CJN.00380116. Epub 2016 Jul 21.'}, {'pmid': '28213606', 'type': 'RESULT', '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 Health Literacy and Outcomes of Childhood Nephrotic Syndrome. Pediatrics. 2017 Mar;139(3):e20161961. doi: 10.1542/peds.2016-1961. Epub 2017 Feb 17.'}, {'pmid': '30976899', 'type': 'RESULT', '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 nephrotic syndrome: a prospective cohort study. Pediatr Nephrol. 2019 Sep;34(9):1599-1605. doi: 10.1007/s00467-019-04255-1. Epub 2019 Apr 11.'}, {'pmid': '30732999', 'type': 'RESULT', '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: Insight into Nephrotic Syndrome Cohort. J Pediatr. 2019 May;208:251-257.e1. doi: 10.1016/j.jpeds.2018.12.048. Epub 2019 Feb 4.'}, {'pmid': '41091558', 'type': 'DERIVED', 'citation': 'Robinson CH, Aman N, Banh THM, Brooke J, Dhillon V, Garner M, Licht C, McKay A, Pearl R, Radhakrishnan S, Rasool K, Selvathesan N, Teoh CW, Vasilevska-Ristovska J, Parekh RS. Challenging Clinical Practice Guideline Definitions in Childhood Nephrotic Syndrome. Clin J Am Soc Nephrol. 2025 Dec 1;20(12):1767-1779. doi: 10.2215/CJN.0000000842. Epub 2025 Oct 15.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/23351121', 'label': 'PubMed: The rationale and design of Insight into Nephrotic Syndrome: Investigating Genes, Health and Therapeutics (INSIGHT): a prospective cohort study of childhood nephrotic syndrome.'}]}, 'descriptionModule': {'briefSummary': 'INSIGHT is a longitudinal study of childhood nephrotic syndrome to determine genetic, serologic and environmental factors contributing to nephrotic syndrome and disease progression.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with nephrotic syndrome. Children are recruited from Toronto and surrounding region with additional sites added later.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. diagnosis of nephrotic syndrome\n2. signed informed consent and assent appropriate for age\n3. ages 6 months -18 years old and\n4. ability to complete questionnaires\n\nExclusion Criteria:\n\n1. congenital nephrotic syndrome (less than age 1)\n2. syndromic disease with multiple organ involvement\n3. inability to provide consent by primary care providers\n4. conditions such as systemic lupus erythematous.'}, 'identificationModule': {'nctId': 'NCT01605266', 'acronym': 'INSIGHT', 'briefTitle': 'INSIGHT (Insight Into Nephrotic Syndrome)', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'INSIGHT (Insight Into Nephrotic Syndrome: Investigating Genes, Health and Therapeutics)', 'orgStudyIdInfo': {'id': '1000021384'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nephrotic Syndrome', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L6R 3J7', 'city': 'Brampton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Rachel J Pearl, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rulan Parekh, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Diane Hebert, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christoph Licht, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'William Osler Health System, Brampton Civic Hospital and Peel Memorial Centre for Integrated Health and Wellness', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'L8L 8E7', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Rahul Chanchlani, MD', 'role': 'CONTACT'}, {'name': 'Rahul Chanchlani, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hamilton Health Sciences Corporation - McMaster University Medical Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M1E 4B9', 'city': 'Scarborough Village', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Hubert Wong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rulan Parekh, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Diane Hebert, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lisa Strug, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christoph Licht, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rouge Valley Health System, Rouge Valley Centenary', 'geoPoint': {'lat': 43.73899, 'lon': -79.22124}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Rulan Parekh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Diane Hebert, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lisa Strug, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christoph Licht, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Valerie Langlois, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Damien Noone, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chia Wei Teoh, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Seetha Radhakrishnan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Rulan Parekh, MD', 'role': 'CONTACT', 'email': 'rulan.parekh@sickkids.ca', 'phone': '416-813-7654', 'phoneExt': '306459'}], 'overallOfficials': [{'name': 'Rulan Parekh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Physician', 'investigatorFullName': 'Rulan Parekh', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}