Phase 2
Completed N=23
Novel Therapies for Resistant FSGS (FONTII): Phase II Clinical Trial
Source: ClinicalTrials.gov NCT00814255 ↗Enrolled (actual)
23
Serious AEs
23.8%
Results posted
Jul 2016
Primary outcomePrimary: Number of Participants With a Reduction in Proteinuria at 6 Months by > 50% of the Value at Screening AND Stable GFR Defined as Greater Than 75 ml/Min/1.73m2 in Those With an Initial Value Above 90 OR Within 25% of Baseline for Remaining Patients — 0; 2; 2 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Reduction in Proteinuria at 6 Months by > 50% of the Value at Screening AND Stable GFR Defined as Greater Than 75 ml/Min/1.73m2 in Those With an Initial Value Above 90 OR Within 25% of Baseline for Remaining Patients |
0; 2; 2 | — |
| SECONDARY Patient Satisfaction Score Using the Treatment Satisfaction Questionnaire for Medication (TSQM Questionnaire) |
— | — |
| SECONDARY Number of Participants With Adverse Events |
7; 7; 7 | — |
| SECONDARY Percent Change in Proteinuria |
— | — |
| SECONDARY Percent Change in or Time to Doubling of Serum Creatinine |
— | — |
Eligibility 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 1.0 g/g creatinine on first morning void
- Steroid resistance defined as failure to achieve sustained Up/c 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
Data sourced from ClinicalTrials.gov (NCT00814255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.