Oral Galactose in Children With Steroid Resistant Nephrotic Syndrome
|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|
Show Detailed Description
|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.
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 Research Institute|
|Study Director:||Kristen Sgambat, MS, RD||Children's Research Institute|