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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00816504
Recruitment Status : Withdrawn (Under additional IRB Review)
First Posted : January 1, 2009
Last Update Posted : September 7, 2015
Medical College of Wisconsin
Information provided by (Responsible Party):
Howard Trachtman MD, Northwell Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Focal Segmental Glomerulosclerosis Drug: Galactose Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Galactose on Permeability Factor in Patients With Focal Segmental Glomerulosclerosis (FSGS)and Chronic Kidney Disease Stage 5
Study Start Date : December 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: 1
Drug: Galactose
Oral galactose, 0.2 g/kg/dose twice daily for 28 days

Primary Outcome Measures :
  1. Reduction in FSGS permeability factor [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Secondary FSGS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00816504

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United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Northwell Health
Medical College of Wisconsin
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Principal Investigator: Howard Trachtman, MD Schneider Children's Hospital
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Responsible Party: Howard Trachtman MD, Investigator, Northwell Health Identifier: NCT00816504    
Other Study ID Numbers: 08-124
First Posted: January 1, 2009    Key Record Dates
Last Update Posted: September 7, 2015
Last Verified: September 2015
Keywords provided by Howard Trachtman MD, Northwell Health:
Permeability factor
Primary FSGS, resistant to immunosuppressive medication
Additional relevant MeSH terms:
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Glomerulosclerosis, Focal Segmental
Kidney Diseases
Urologic Diseases