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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01113385 |
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Date of registration:
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28/04/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Oral Galactose in Children With Steroid Resistant Nephrotic Syndrome
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Scientific title:
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Effect of Oral Galactose on the Level of Focal Sclerosis Permeability Factor and Proteinuria in Children With Steroid Resistant Nephrotic Syndrome: A Pilot Study |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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7 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01113385 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Kristen Sgambat, MS, RD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Research Institute |
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Name:
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Asha Moudgil, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Research Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 2-21 years old
2. Biopsy proven FSGS or minimal change with steroid resistance
3. Presence of FSPF (defined as permeability activity >0.5)
4. Presence of nephrotic range proteinuria (urine protein: creatinine ratio >2) at the
time of enrollment.
5. 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.
6. Stable serum creatinine (change of less than 0.3 mg/dl) in the prior 3 months.
7. Schwartz estimated (e) glomerular filtration rate (GFR) >60ml/min/1.73m2
Exclusion Criteria:
1. Secondary FSGS
2. Onset of nephrotic syndrome in infancy.
3. 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).
4. Decreasing renal function (persistent increase in serum creatinine of greater than 0.3
mg/dl over baseline in the prior 3 months).
5. Use of another investigational drug
6. Pregnant or unable to comply with contraceptive measures in females of child bearing
age
7. eGFR < 60 ml/min per 1.73 m2
8. Children with Galactosemia
9. Children with type 1 or 2 diabetes
Age minimum:
2 Years
Age maximum:
21 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Focal Segmental Glomerulosclerosis
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Steroid Resistant Nephrotic Syndrome
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Intervention(s)
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Drug: D-Galactose
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Primary Outcome(s)
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Focal Segmental Glomerulosclerosis Permeability Factor (FSPF)
[Time Frame: 16 weeks]
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Secondary Outcome(s)
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Number of Participants Achieving Complete or Partial Remission at 16 Weeks
[Time Frame: 16 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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