Thyroid Dysfunction in Patients With Nephrotic Syndrome
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
This study is to evaluate Thyroid Hormone profile in patients with Nephrotic syndrome to identify clinical predictor of Thyroid dysfunction in patients with Nephrotic syndrome
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2020
CompletedFirst Posted
Study publicly available on registry
March 26, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMarch 26, 2020
March 1, 2020
1 year
January 12, 2020
March 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Hypothyroidism in patients with nephrotic syndrome
Decrease T3 and/or T4 and/or increase TSH in patients with proteinurea more than 3.5 mg
1year
Study Arms (1)
Nephrotic syndrome patients
OTHERThis study is to evaluate Thyroid Hormone profile in patients with Nephrotic syndrome to identify clinical predictor of Thyroid dysfunction in patients with Nephrotic syndrome
Interventions
Laboratory measures will include Blood sugar Urine analysis with 24hrs protein in urine Complete blood count Liver function tests Kidney functions test Plasma lipid levels Thyroid functions test Abdominal ultrasound Antithyrperoxidase Renal biopsy
Eligibility Criteria
You may qualify if:
- Nephrotic syndrome defined by the following:
- Generalized edema
- Urine protein excretion \> 3,5 g/24 hours
- Urine protein to creatinine ratio \> 3,500mg/g
- Serum albumin level less than 30 g/L
You may not qualify if:
- \- 1) Patients \< 18 years old 2) Patients who have Thyroid diseases, current or past history of thyroid hormone or antithyroid drug intake.
- \) Patients who have diabetes mellitus or autoimmune diseases as systemic lupus erythematosus and RA 4) Medications known to affect thyroid function. 5) Patients with liver cirrhosis and chronic liver disease as augmentin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merna Makramlead
- Assiut Universitycollaborator
Related Publications (2)
McCloskey O, Maxwell AP. Diagnosis and management of nephrotic syndrome. Practitioner. 2017 Feb;261(1801):11-5.
PMID: 29020719BACKGROUNDBradley SE, Stephan F, Coelho JB, Reville P. The thyroid and the kidney. Kidney Int. 1974 Nov;6(5):346-65. doi: 10.1038/ki.1974.119. No abstract available.
PMID: 4431166BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Thyroid Dysfunction in patients with nephrotic syndrome
Study Record Dates
First Submitted
January 12, 2020
First Posted
March 26, 2020
Study Start
October 1, 2020
Primary Completion
October 1, 2021
Study Completion
October 1, 2022
Last Updated
March 26, 2020
Record last verified: 2020-03