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

Completed · Phase 2

Conditions studied: Focal Segmental Glomerulosclerosis

In brief

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 facts

Study ID

NCT00814255

Run by

NYU Langone Health

People needed

32

Starts

2008-12-01

Expected to finish

2014-02-01

Last updated by the study team

2016-07-11

Who can join

Age: 1 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary FSGS confirmed by renal biopsy OR documentation of a genetic mutation in a podocyte protein associated with the disease
• Failure to respond to prior therapy at least one of the following immunosuppressive medications -- cyclosporine, tacrolimus, mycophenolate mofetil, sirolimus - or other agents prescribed to lower proteinuria
• Age 1-65 years at onset of proteinuria
• Age 1-65 years at time of randomization
• Estimated GFR ≥40 mL/min/1.73 m2 using Schwartz (age <18 yr) or Cockroft-Gault (age <18 yr) formula at screening and ≥30 mL/min/1.73 m2 at the end of the Run-In Period and at the time of randomization
• Up/c > 1.0 g/g creatinine on first morning void
• Steroid resistance defined as failure to achieve sustained Up/c < 1.0 following a standard course of prednisone/prednisolone/methylprednisolone prescribed for FSGS therapy, OR contraindication/anticipated intolerance to steroid therapy defined as severe obesity, documented decreased bone density, family history of diabetes, or a psychiatric disorder.
• Willingness to follow the protocol, including medications, baseline and follow-up visits, and procedures.

You may not qualify if…

• Lactation, pregnancy, or refusal of birth control in women of child bearing potential
• Participation in another therapeutic trial involving protocol mandated administration of a immunosuppressive medication concurrently or 30 days prior to randomization
• Active/serious infection (including, but not limited to Hepatitis B or C, HIV)
• History of malignancy
• Abnormality in age appropriate cancer screening in accord with ACS 2003 guidelines (appendix 17.6)
• Patients with uncontrolled blood pressure > 140/90 or > 95th percentile for age/height at the end of the run in period
• Diabetes mellitus Type I or II
• Organ transplantation
• Congestive heart failure
• History of prior myocardial infarction
• SLE or multiple sclerosis
• Hepatic disease, defined as serum ALT/AST levels more than 2.5x the upper limit of normal
• Hematocrit <27%
• Immunosuppressive therapy with cyclosporine, tacrolimus, mycophenolate mofetil, azathioprine, or rapamycin in the 30 days prior or Rituximab in the 90 days prior to randomization
• Prior treatment with the study medications, rosiglitazone or adalimumab
• Allergy to one of the study medications, i.e., rosiglitazone, adalimumab, lisinopril, losartan or atorvastatin

Where it is running

• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University of Kansas — Kansas City, Kansas, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Cardinal Glennon Children's Medical Center — St Louis, Missouri, United States
• Steven and Alexandra Cohen Children's Medical Center of New York — New Hyde Park, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Doernbecher Children's Hospital — Portland, Oregon, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Texas Tech University — El Paso, Texas, United States
• University of Alberta — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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