Trial · NCT01113385
Oral Galactose in Children With Steroid Resistant Nephrotic Syndrome
NCT01113385, Not applicable, Completed, Children's National Research Institute; results first posted 2014-09-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Galactose in Children With Steroid Resistant Nephrotic Syndrome. Trials, record NCT01113385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01113385
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Galactose in Children With Steroid Resistant Nephrotic Syndrome
- NCT number
- NCT01113385
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 7 participants, actual
- Lead sponsor
- Children's National Research Institute
- Conditions
- Focal Segmental Glomerulosclerosis, Steroid Resistant Nephrotic Syndrome
- Interventions
- D-Galactose
- First posted
- 2010-04-29
- Last updated
- 2014-09-15
- Results first posted
- 2014-09-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Focal Segmental Glomerulosclerosis Permeability Factor (FSPF) | 16 weeks | 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. |
| Secondary | Number of Participants Achieving Complete or Partial Remission at 16 Weeks | 16 weeks | Results will be considered clinically significant if the following criteria is met in response to oral galactose therapy at week 16. Complete remission is defined as (Urine Protein:Creatinine ratio \[UPC\] \<0.2 g/g). Partial remission is defined as UPC 0.2-2 g/g. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Focal Segmental Glomerulosclerosis Permeability Factor (FSPF) | 16 weeks | Palb | MEAN | |
| SECONDARY | Number of Participants Achieving Complete or Partial Remission at 16 Weeks | 16 weeks | participants in remission at 16 weeks | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Focal Segmental Glomerulosclerosis Permeability Factor (FSPF) | Galactose | Baseline FSPF | 0.69 | Standard Deviation 0.11 | Palb |
| Focal Segmental Glomerulosclerosis Permeability Factor (FSPF) | Galactose | 16 Week FSPF | 0.35 | Standard Deviation 0.21 | Palb |
| Number of Participants Achieving Complete or Partial Remission at 16 Weeks | Galactose | 0 | participants in remission at 16 weeks |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Galactose | 7 | |
| Overall Study | COMPLETED | Galactose | 7 | |
| Overall Study | NOT COMPLETED | Galactose | 0 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Galactose | 1 | 7 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Galactose | ||
| Total, other adverse events | Galactose | 1 | 7 |
| Total, serious adverse events | Galactose | 0 | 7 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01113385
GET https://conductscience.org/api/trials/v1/NCT01113385/registered