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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00814255
• Date of registration: 22/12/2008
• Prospective Registration: No
• Primary sponsor: New York University School of Medicine
• Public title: Novel Therapies for Resistant FSGS (FONTII): Phase II Clinical Trial FONTII
• Scientific title: Novel Therapies for Resistant Focal Segmental Glomerulosclerosis
• Date of first enrolment: December 2008
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00814255
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: Jennifer Gassman, PhD
• Affiliation: The Cleveland Clinic

• Name: Debbie Gipson, MD
• Affiliation: University of Michigan

• Name: Howard Trachtman, MD
• Affiliation: NYU Langone Medical Center

Key inclusion & exclusion 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



Age minimum: 1 Year
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Focal Segmental Glomerulosclerosis

Intervention(s)

Drug: galactose

Drug: Adalimumab

Drug: Lisinopril, losartan, and atorvastatin

Primary Outcome(s)

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 [Time Frame: baseline and 6 months]

Secondary Outcome(s)

Patient Satisfaction Score Using the Treatment Satisfaction Questionnaire for Medication (TSQM Questionnaire) [Time Frame: Baseline and 6 months]

Percent Change in or Time to Doubling of Serum Creatinine [Time Frame: Baseline and 6 months]

Number of Participants With Adverse Events [Time Frame: Up to 7 months]

Percent Change in Proteinuria [Time Frame: Baseline and 6 months]

Secondary ID(s)

DK70341FII

R33DK070341

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

The Cleveland Clinic

University of Michigan

Results

• Results available: Yes
• Date Posted: 11/07/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00814255