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Effect of Galactose on Permeblity Factor in Patients With FSGS and CKD Stage 5

This study has suspended participant recruitment.
(Under additional IRB Review)
Sponsor:
Collaborator:
Medical College of Wisconsin
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00816504
First received: December 31, 2008
Last updated: September 9, 2009
Last verified: September 2009

December 31, 2008
September 9, 2009
December 2008
December 2009   (final data collection date for primary outcome measure)
Reduction in FSGS permeability factor [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00816504 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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

This study is a proof-of-concept clinical study designed to test the hypothesis that oral administration of galactose can lower the level of a circulating factor that increases glomerular permeability to albumin in patients with resistant FSGS.

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.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Focal Segmental Glomerulosclerosis
Drug: Galactose
Oral galactose, 0.2 g/kg/dose twice daily for 28 days
Experimental: 1
Galactose
Intervention: Drug: Galactose
Trachtman H, Greenbaum LA, McCarthy ET, Sharma M, Gauthier BG, Frank R, Warady B, Savin VJ. Glomerular permeability activity: prevalence and prognostic value in pediatric patients with idiopathic nephrotic syndrome. Am J Kidney Dis. 2004 Oct;44(4):604-10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
5
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary FSGS
  • CKD Stage 5
  • Resistance to steroids and another immunosuppressive medication

Exclusion Criteria:

  • Secondary FSGS
Both
2 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00816504
08-124
No
Howard Trachtman, Schneider Children's Hospital
North Shore Long Island Jewish Health System
Medical College of Wisconsin
Principal Investigator: Howard Trachtman, MD Schneider Children's Hospital
North Shore Long Island Jewish Health System
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP