- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03074357
Urine, DNA and Clinical Information Collection From Patients With Alport Nephropathy.
Urine, DNA and Retrospective Clinical Information Collection From Patients With Alport Nephropathy.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
• Able to communicate well with the investigator, to understand and comply with the requirements of the study and able to provide written informed consent (parent or legal guardian for pediatric and adolescent subjects), which must be obtained before any assessment is performed.
Alport Subject-Specific Inclusion Criteria:
- Participation in CPLATFRM2201
- Physically able to provide a single first-morning urine sample of at least 30 mL (one ounce). Alport patients who have initiated dialysis therapy since participation in CPLATFRM2201 are exempt from this criterion and may still participate in this study.
Healthy Volunteer-Specific Inclusion Criteria:
• Male and Female Volunteers (may include healthy siblings of Alport patients) aged 5 to 15 years.
Exclusion Criteria:
Alport Subject-Specific Exclusion Criteria:
• None
Healthy Volunteer-Specific Exclusion Criteria:
- Use of investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
- Known history of one of more of (a) hematuria (gross or microscopic), (b)audiological deficits, (c) fixed (non-orthostatic) proteinuria, or (d) reduced renal filtration function with serum creatinine (Cr) above the upper limit of the normal age-specific reference range, on at least 2 prior occasions (serum Cr need not be measured specifically for eligibility).
- Any other clinically significant underlying medical conditions as judged by the PI.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urine levels of biomarkers - corrected for urine creatinine
Time Frame: Day 1
|
Urine levels of biomarkers, corrected for urine creatinine, in Alport subjects stratified by magnitude of proteinura.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urine level of biomarkers - corrected for urine creatinine
Time Frame: Day 1
|
Urine levels of biomarkers, corrected for urine creatinine, in healthy subjects.
|
Day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBASICHR0005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Alport Nephropathy
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Novartis PharmaceuticalsTerminated
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Chinook Therapeutics U.S., Inc.Active, not recruitingDiabetic Kidney Disease | Focal Segmental Glomerulosclerosis | Immunoglobulin A Nephropathy | IgA Nephropathy | Diabetic Nephropathy Type 2 | Alport SyndromeUnited States, Spain, Korea, Republic of, Australia, Italy, United Kingdom
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Josep M CruzadoWyeth is now a wholly owned subsidiary of PfizerCompletedGlomerulonephritis, IGA | IGA Nephropathy | Nephropathy, IGASpain
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Visterra, Inc.CompletedImmunoglobulin A Nephropathy | IgA Nephropathy | IgAN - IgA NephropathyUnited States
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National Institute of Allergy and Infectious Diseases...Terminated
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Russian Academy of Medical SciencesRussian Scientific Center of SurgeryCompletedAcute Graft Rejection | Chronic Allograft Nephropathy | Polyomavirus-related Transplant NephropathyRussian Federation
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Shanghai Children's HospitalRecruitingAlport Syndrome, X-LinkedChina
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Genzyme, a Sanofi CompanyCompletedAlport Syndrome Patients With eGFR Between 45-90 ml/Min/1.73 m2France, Germany, Australia, United States, United Kingdom, Canada
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Assiut UniversityUnknownObstructive Nephropathy
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Hospital Universitario 12 de OctubreInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz; Fundación... and other collaboratorsCompletedMEMBRANOUS NEPHROPATHYSpain