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

This study has been withdrawn prior to enrollment.
(Under additional IRB Review)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816504
First Posted: January 1, 2009
Last Update Posted: September 7, 2015
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.
Collaborator:
Medical College of Wisconsin
Information provided by (Responsible Party):
Howard Trachtman MD, North Shore Long Island Jewish Health System
  Purpose
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 Intervention Phase
Focal Segmental Glomerulosclerosis Drug: Galactose Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Howard Trachtman MD, North Shore Long Island Jewish Health System:

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

Enrollment: 0
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Galactose
Drug: Galactose
Oral galactose, 0.2 g/kg/dose twice daily for 28 days

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.

  Eligibility

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Secondary FSGS
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00816504


Locations
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Northwell Health
Medical College of Wisconsin
Investigators
Principal Investigator: Howard Trachtman, MD Schneider Children's Hospital
  More Information

Publications:
Responsible Party: Howard Trachtman MD, Investigator, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00816504     History of Changes
Other Study ID Numbers: 08-124
First Submitted: December 31, 2008
First Posted: January 1, 2009
Last Update Posted: September 7, 2015
Last Verified: September 2015

Keywords provided by Howard Trachtman MD, North Shore Long Island Jewish Health System:
FSGS
Permeability factor
Galactose
Primary FSGS, resistant to immunosuppressive medication

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases