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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: Completed NA study of Focal Segmental Glomerulosclerosis and Steroid Resistant Nephrotic Syndrome, sponsored by Children's National Research Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
FSPF is reported in relation to its induction of glomerular albumin permeability (Palb) of isolated glomeruli on a range from 0 to 1, with 0 indicative of normal glomeruli and 1 indicative of injury to the permeability barrier. Results will be considered clinically significant if the following criteria is met in response to oral galactose therapy at week 16: Reduction in FSPF to \<0.5 Palb or decrease in FSPF by \> 0.3 Palb.
Conditions Studied
Interventions
- DRUG D-Galactose
Study Locations (1)
District of Columbia
- Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2009-10 |
| Est. Completion | 2013-03 |
| Phase | NA |
What the finished NCT01113385 record still lists
NCT01113385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 236-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Focal Segmental Glomerulosclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01113385's enrollment target sits among peer trials
7 20th of 19 the lowest of 19 other Focal Segmental Glomerulosclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Focal Segmental Glomerulosclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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-
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