Novel Therapies for Resistant FSGS (FONTII): Phase II Clinical Trial (FONTII)
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ClinicalTrials.gov Identifier: NCT00814255 |
Recruitment Status :
Completed
First Posted : December 24, 2008
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Focal Segmental Glomerulosclerosis | Drug: Adalimumab Drug: Lisinopril, losartan, and atorvastatin Drug: galactose | Phase 2 |

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

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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

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

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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Primary FSGS Steroid Resistant Rosiglitazone |
Adalimumab Resistant primary FSGS GALACTOSE |
Glomerulosclerosis, Focal Segmental Glomerulonephritis Nephritis Kidney Diseases Urologic Diseases Adalimumab Losartan Lisinopril Atorvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites 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 |