Inclusion Criteria |
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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 |