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

Part of paid clinical trials in Miami, Florida.

Sponsor
NYU Langone Health
Study ID
NCT00814255
Phase
PHASE2
Status
Completed

Conditions

  • Focal Segmental Glomerulosclerosis

Eligibility Criteria

Sex
ALL
Age
1 Year - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Adalimumab 24 mg/m\^2 (maximum dose 40 mg) sc q 14 days
  • Lisinopril, losartan, and atorvastatin — DRUG
    Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day
  • galactose — DRUG
    galactose 0.2 g/kg/dose (maximum dose 15 g)po BID

Study Details

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).

Key Dates

Start date
Dec 31, 2008
Status verified
Jul 2016
Primary completion
Jun 30, 2013
Completion
Feb 28, 2014

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 2
    Conservative medical therapy plus adalimumab
  • Active Comparator: 1
    Conservative medical therapy (lisinopril, losartan, atorvastatin)
  • Experimental: conservative medical therapy plus galactose
    drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID

Primary Outcome Measure

Number of Participants With a Reduction in Proteinuria at 6 Months by > 50% of the Value at Screening AND Stable GFR Defined as Greater Than 75 ml/Min/1.73m2 in Those With an Initial Value Above 90 OR Within 25% of Baseline for Remaining Patients [ Time Frame: baseline and 6 months ]

Locations (17)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-
Emory UniversityAtlantaGeorgia30322-
University of KansasKansas CityKansas66160-
Boston Children's HospitalBostonMassachusetts02115-
University of MichiganAnn ArborMichigan48109-
Mayo ClinicRochesterMinnesota55901-
Children's Mercy HospitalKansas CityMissouri64108-
Cardinal Glennon Children's Medical CenterSt LouisMissouri63104-
Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde ParkNew York11040-
Columbia University Medical CenterNew YorkNew York10032-
NYU Langone Medical CenterNew YorkNew York10016-
Carolinas Medical CenterCharlotteNorth Carolina28207-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Ohio State UniversityColumbusOhio43205-
Doernbecher Children's HospitalPortlandOregon97239-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Texas Tech UniversityEl PasoTexas79905-

Find similar trials in Miami, FL

By research site
University of Miami· Miami, FLEmory University· Atlanta, GAUniversity of Kansas· Kansas City, KSBoston Children's Hospital· Boston, MAUniversity of Michigan· Ann Arbor, MIMayo Clinic· Rochester, MN

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