Oral Galactose in Children With Steroid Resistant Nephrotic Syndrome
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|ClinicalTrials.gov Identifier: NCT01113385|
Recruitment Status : Completed
First Posted : April 29, 2010
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Focal Segmental Glomerulosclerosis Steroid Resistant Nephrotic Syndrome||Drug: D-Galactose||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Oral Galactose on the Level of Focal Sclerosis Permeability Factor and Proteinuria in Children With Steroid Resistant Nephrotic Syndrome: A Pilot Study|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.
Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally.
Other Name: Galactose
- Focal Segmental Glomerulosclerosis Permeability Factor (FSPF) [ Time Frame: 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.
- Number of Participants Achieving Complete or Partial Remission at 16 Weeks [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113385
|United States, District of Columbia|
|Children's National Medical Center|
|Washington DC, District of Columbia, United States, 20010|
|Principal Investigator:||Asha Moudgil, MD||Children's National Research Institute|
|Study Director:||Kristen Sgambat, MS, RD||Children's National Research Institute|