- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00816504
Effect of Galactose on Permeblity Factor in Patients With FSGS and CKD Stage 5
Effect of Galactose on Permeability Factor in Patients With Focal Segmental Glomerulosclerosis (FSGS)and Chronic Kidney Disease Stage 5
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with resistant FSGS have persistent proteinuria and a high risk of progression to end stage kidney disease (ESKD). A circulating factor that increases glomerular permeability to albumin (Palb) has been detected in over 50% of these patients. While the molecular identity of the factor has not been fully established, in vitro studies and limited clinical experience suggest that galactose can reduce the level of the FSGS permeability factor.
This study is a pilot study to determine if oral administration of galactose can lower the circulating level of the FSGS permeability factor.
Five patients with biopsy proven primary FSGS - native or transplant kidney, receiving plasmapheresis - who are resistant to steroids and one other immunosuppressive agents will be studied.
The only eligibility factor is presence of the FSGS permeability factor.
The experimental intervention is administration of galactose, orally, 0.2 g/kg body weight/dose twice daily. the duration of treatment will be 28 days,.
Patients will be seen on days 0, 14, and 28 of treatment. They will be seen at week 8, 16 and 24 after discontinuation of the galactose.
Physical examination and routine laboratory tests (SMAC, CBC, urine protein:creatinine ratio in an early morning sample) will be done at each visit. The FSGS permeability factor will be assayed at days 0 and 28 of treatment and 6 months after discontinuation of the galactose. The permeability factor will be tested in the laboratory of Virginia Savin MD (Medical college of Wisconsin) using previously described methods.
All other treatments will be unchanged during the 28 day oral galactose Treatment Period.
The study will be analyzed based on the number of patients in whom the FSGS permeability factor is lowered to normal levels.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary FSGS
- CKD Stage 5
- Resistance to steroids and another immunosuppressive medication
Exclusion Criteria:
- Secondary FSGS
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Galactose
|
Oral galactose, 0.2 g/kg/dose twice daily for 28 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in FSGS permeability factor
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Howard Trachtman, MD, Schneider Children's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-124
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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