We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00814255
Recruitment Status : Completed
First Posted : December 24, 2008
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
University of Michigan
The Cleveland Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
NYU Langone Health

Brief 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).

Condition or disease Intervention/treatment Phase
Focal Segmental Glomerulosclerosis Drug: Adalimumab Drug: Lisinopril, losartan, and atorvastatin Drug: galactose Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Therapies for Resistant Focal Segmental Glomerulosclerosis
Study Start Date : December 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : February 2014

Arm Intervention/treatment
Experimental: 2
Conservative medical therapy plus adalimumab
Drug: Adalimumab
Adalimumab 24 mg/m^2 (maximum dose 40 mg) sc q 14 days

Active Comparator: 1
Conservative medical therapy (lisinopril, losartan, atorvastatin)
Drug: Lisinopril, losartan, and atorvastatin
Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day

Experimental: conservative medical therapy plus galactose
drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID
Drug: galactose
galactose 0.2 g/kg/dose (maximum dose 15 g)po BID

Primary Outcome Measures :
  1. 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 ]
    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.

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

  2. Number of Participants With Adverse Events [ Time Frame: Up to 7 months ]
  3. Percent Change in Proteinuria [ Time Frame: Baseline and 6 months ]
  4. Percent Change in or Time to Doubling of Serum Creatinine [ Time Frame: Baseline and 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814255

Show Show 18 study locations
Sponsors and Collaborators
NYU Langone Health
University of Michigan
The Cleveland Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Layout table for investigator information
Principal Investigator: Howard Trachtman, MD NYU Langone Medical Center
Principal Investigator: Debbie Gipson, MD University of Michigan
Principal Investigator: Jennifer Gassman, PhD The Cleveland Clinic
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00814255    
Other Study ID Numbers: DK70341FII
R33DK070341 ( U.S. NIH Grant/Contract )
First Posted: December 24, 2008    Key Record Dates
Results First Posted: July 11, 2016
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: will comply with NIDDK guidelines
Keywords provided by NYU Langone Health:
Primary FSGS
Steroid Resistant
Resistant primary FSGS
Additional relevant MeSH terms:
Layout table for MeSH terms
Glomerulosclerosis, Focal Segmental
Kidney Diseases
Urologic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs