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NCT01113385 · ClinicalTrials.gov registry record · NA

Oral Galactose in Children With Steroid Resistant Nephrotic Syndrome

A NA study of Focal Segmental Glomerulosclerosis and Steroid Resistant Nephrotic Syndrome, sponsored by Children's National Research Institute.

Completed
Registry status
NA
Development phase
7
Enrollment target
1
Study location

NCT01113385 is a NA study of Focal Segmental Glomerulosclerosis and Steroid Resistant Nephrotic Syndrome that has completed, run by Children's National Research Institute. The registered enrollment target is 7 participants, below the 236-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01113385, a NA study of Focal Segmental Glomerulosclerosis and Steroid Resistant Nephrotic Syndrome, has completed, sponsored by Children's National Research Institute.

COMPLETED
Registry status
NA
Development phase
7 participants
Enrollment target
1
Study location

Study Summary

Focal Segmental Glomerulosclerosis (FSGS) is a devastating kidney disease which is difficult to treat and carries a poor prognosis, with 50% of affected children progressing to end stage renal disease (ESRD). The purpose of this study is to investigate oral galactose as a benign treatment for FSGS in children. The investigators hypothesize that galactose, a simple milk sugar thought to bind to the protein factor (FSPF) that causes FSGS thereby inactivating it and stopping it from damaging the kidney, resulting in a reduction in glomerular permeability to albumin and decrease in proteinuria in children with nephrotic syndrome secondary to FSGS.

Interventions

  • DRUG D-Galactose

Study Locations (1)

District of Columbia

  • Children's National Medical Center - Washington D.C.

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2009-10
Est. Completion 2013-03
Phase NA

What the Registry Record Tells You About NCT01113385

The ClinicalTrials.gov registry entry for NCT01113385 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 236-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (97% lower). The listed sponsor is Children's National Research Institute, which has 92 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Focal Segmental Glomerulosclerosis appearing as the primary indexed condition, and to 1 intervention - of which D-Galactose is the first listed.

NCT01113385 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.

Frequently Asked Questions

What is clinical trial NCT01113385 about?

NCT01113385 is a clinical study titled "Oral Galactose in Children With Steroid Resistant Nephrotic Syndrome". Focal Segmental Glomerulosclerosis (FSGS) is a devastating kidney disease which is difficult to treat and carries a poor prognosis, with 50% of affected children progressing to end stage renal disease (ESRD). The purpose of this study is to investigate oral galactose as a benign treatment for FSGS i...

What is the current status of trial NCT01113385?

This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2009-10. Estimated completion is 2013-03.

What conditions does trial NCT01113385 study?

This clinical trial studies the following conditions: Focal Segmental Glomerulosclerosis, Steroid Resistant Nephrotic Syndrome.

What interventions are being tested in trial NCT01113385?

The interventions under investigation include: D-Galactose (DRUG).

Who is sponsoring clinical trial NCT01113385?

This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01113385 being conducted?

This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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