Phase 2
N=23
Novel Therapies for Resistant FSGS (FONTII): Phase II Clinical Trial
Focal Segmental Glomerulosclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00814255 ↗Enrolled (actual)
23
Serious AEs
23.8%
Results posted
Jul 2016
Primary outcome: 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 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Adalimumab (Drug); Lisinopril, losartan, and atorvastatin (Drug); galactose (Drug)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jun 2013
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 |
— | — |
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).
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.