NCT00816504

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

December 31, 2008

Last Update Submit

September 3, 2015

Conditions

Focal Segmental Glomerulosclerosis

Keywords

FSGSPermeability factorGalactosePrimary FSGS, resistant to immunosuppressive medication

Outcome Measures

Primary Outcomes (1)

  • Reduction in FSGS permeability factor

    28 days

Study Arms (1)

1

EXPERIMENTAL

Galactose

Drug: Galactose

Interventions

GalactoseDRUG

Oral galactose, 0.2 g/kg/dose twice daily for 28 days

1

Eligibility Criteria

Age2 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Secondary FSGS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • 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.

    PMID: 15384010BACKGROUND

MeSH Terms

Conditions

Glomerulosclerosis, Focal Segmental

Interventions

Galactose

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Howard Trachtman, MD

    Schneider Children's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

December 31, 2008

First Posted

January 1, 2009

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

US(1)