Status:
COMPLETED
Novel Therapies for Resistant FSGS (FONTII): Phase II Clinical Trial
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
University of Michigan
The Cleveland Clinic
Conditions:
Focal Segmental Glomerulosclerosis
Eligibility:
All Genders
1-65 years
Phase:
PHASE2
Brief 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 patie...
Detailed Description
SPECIFIC AIMS A significant percentage of patients with primary FSGS are resistant to corticosteroids and other immunosuppressive medications. In view of the rising incidence of this disease and the g...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00814255
Start Date
December 1 2008
End Date
February 1 2014
Last Update
July 11 2016
Active Locations (18)
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1
University of Miami
Miami, Florida, United States, 33136
2
Emory University
Atlanta, Georgia, United States, 30322
3
University of Kansas
Kansas City, Kansas, United States, 66160
4
Boston Children's Hospital
Boston, Massachusetts, United States, 02115