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Novel Therapies for Resistant FSGS (FONTII): Phase II Clinical Trial

NCT00814255 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-07-11

Study results available
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Summary

This project will test whether adalimumab,and/or galactose can safely reduce proteinuria (abnormal amounts of protein in the urine) and protect kidney function better than standard treatment for patients with focal segmental glomerulosclerosis (FSGS).

Conditions

  • Focal Segmental Glomerulosclerosis

Interventions

DRUG

Adalimumab

Adalimumab 24 mg/m\^2 (maximum dose 40 mg) sc q 14 days

DRUG

Lisinopril, losartan, and atorvastatin

Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day

DRUG

galactose

galactose 0.2 g/kg/dose (maximum dose 15 g)po BID

Sponsors & Collaborators

  • University of Michigan

    collaborator OTHER

  • The Cleveland Clinic

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Howard Trachtman, MD · NYU Langone Medical Center

  • Debbie Gipson, MD · University of Michigan

  • Jennifer Gassman, PhD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2013-06-30
Completion
2014-02-28

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00814255 on ClinicalTrials.gov