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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
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Reduction in FSGS permeability factor [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: December 2008
Estimated Study Completion Date: December 2009
Estimated 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

Ages Eligible for Study:   2 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816504

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

Additional Information:
Provides important information about FSGS  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Howard Trachtman, Schneider Children's Hospital
ClinicalTrials.gov Identifier: NCT00816504     History of Changes
Other Study ID Numbers: 08-124
Study First Received: December 31, 2008
Last Updated: September 9, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 19, 2013