Overview

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

Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
0
Participant gender:
All
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 patients with focal segmental glomerulosclerosis (FSGS).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York University School of Medicine
NYU Langone Health
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Cleveland Clinic
University of Michigan
Treatments:
Adalimumab
Atorvastatin
Atorvastatin Calcium
Lisinopril
Losartan
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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