Table 1.

FONT II Study Eligibility Criteria

Inclusion Criteria
1. Primary FSGS confirmed by renal biopsy
2. Failure to respond to prior therapy with at least one of the following immunosuppressive medications -- cyclosporine, tacrolimus, mycophenolate mofetil, sirolimus - or other agents prescribed to lower proteinuria
3. Age 1-50 years at onset of proteinuria
4. Age 1-51 years at time of randomization
5. Estimated GFR ≥40 mL/min/1.73 m2 using Schwartz (age <18 yr) or Cockcroft-Gault (age ≥ 18 yr) formula at screening and ≥30 mL/min/1.73 m2 at the end of the Run-In Period and prior to randomization
6. Up/c > 1.0 g protein/g creatinine on first morning void
7. 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.
8. Willingness to follow the protocol, including medications, baseline and follow-up visits, and procedures.
Exclusion Criteria
1. Lactation, pregnancy, or refusal of birth control in women of child-bearing potential
2. Participation in another therapeutic trial involving protocol mandated administration of a immunosuppressive medication concurrently or 30 days prior to randomization
3. Active/serious infection (including, but not limited to Hepatitis B or C, HIV)
4. History of malignancy
5. Abnormality in age appropriate cancer screening in accord with ACS 2003 guidelines
6. Patients with uncontrolled blood pressure > 140/90 or > 95th percentile for age/height at the end of the run in period
7. Diabetes mellitus, type 1 or 2
8. Organ or bone marrow transplantation
9. Congestive heart failure
10. History of myocardial infarction
11. SLE or multiple sclerosis
12. Hepatic disease defined as serum ALT/AST more than 2.5× the upper limit of normal
13. Hematocrit <27 vol%
14. Immunosuppressive therapy with cyclosporine, tacrolimus, mycophenolate mofetil, azathioprine, rapamycin, or cyclophosphamide in the 30 days prior or Rituximab in the 90 days prior to randomization
15. Use of corticosteroids in the last 30 days except for minimal dosage required for stabilization of edema
16. Prior treatment with the study medications, galactose or adalimumab
17. Allergy to one of the study medications, i.e., adalimumab, galactose, lisinopril, losartan, atorvastatin
18. Abnormal Pap smear (more than carcinoma in situ 1) unless treated and follow-up indicates a normal Pap smear