NCT04323007

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

January 12, 2020

Last Update Submit

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

OTHER

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

Diagnostic Test: Nephrotic patients

Interventions

Nephrotic patientsDIAGNOSTIC_TEST

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

Nephrotic syndrome patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Related Publications (2)

  • McCloskey O, Maxwell AP. Diagnosis and management of nephrotic syndrome. Practitioner. 2017 Feb;261(1801):11-5.

    PMID: 29020719BACKGROUND
  • Bradley 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

Mostafa Haridi, Prof

CONTACT

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