Oral Galactose in Children With Steroid Resistant Nephrotic Syndrome (NCT01113385) | Clinical Trial Compass
CompletedNot Applicable
Oral Galactose in Children With Steroid Resistant Nephrotic Syndrome
United States7 participantsStarted 2009-10
Plain-language 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.
Who can participate
Age range2 Years – 21 Years
SexALL
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Inclusion criteria
✓. 2-21 years old
✓. Biopsy proven FSGS or minimal change with steroid resistance
✓. Presence of FSPF (defined as permeability activity \>0.5)
✓. Presence of nephrotic range proteinuria (urine protein: creatinine ratio \>2) at the time of enrollment.
✓. Persistent nephrotic range proteinuria despite being on stable immunosuppressive medications (cyclosporine, tacrolimus or mycophenolate mofetil) for at least 12 weeks and/or persistent nephrotic range proteinuria despite being on stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) for 12 weeks.
✓. Stable serum creatinine (change of less than 0.3 mg/dl) in the prior 3 months.
✕. Presence of acute renal failure (as defined by acute kidney injury criteria) at the time of enrollment. These children can be enrolled 1 month after resolution of acute renal failure (ARF).
✕. Decreasing renal function (persistent increase in serum creatinine of greater than 0.3 mg/dl over baseline in the prior 3 months).
✕. Use of another investigational drug
✕. Pregnant or unable to comply with contraceptive measures in females of child bearing age