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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00814255
First Posted: December 24, 2008
Last Update Posted: July 11, 2016
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.
Collaborators:
University of Michigan
The Cleveland Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose
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 Intervention Phase
Focal Segmental Glomerulosclerosis Drug: Adalimumab Drug: Lisinopril, losartan, and atorvastatin Drug: galactose Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Therapies for Resistant Focal Segmental Glomerulosclerosis

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 32
Study Start Date: December 2008
Study Completion Date: February 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

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.


Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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


Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Kansas
University of Kansas
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, United States, 63104
United States, New York
Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
NYU Langone Medical Center
New York, New York, United States, 10016
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28207
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Ohio State University
Columbus, Ohio, United States, 43205
United States, Oregon
Doernbecher Children's Hospital
Portland, Oregon, United States, 97239
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Texas Tech University
El Paso, Texas, United States, 79905
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2R7
Sponsors and Collaborators
New York University School of Medicine
University of Michigan
The Cleveland Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00814255     History of Changes
Other Study ID Numbers: DK70341FII
R33DK070341 ( U.S. NIH Grant/Contract )
First Submitted: December 22, 2008
First Posted: December 24, 2008
Results First Submitted: September 9, 2015
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 New York University School of Medicine:
Primary FSGS
Steroid Resistant
Rosiglitazone
Adalimumab
Resistant primary FSGS
GALACTOSE

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Atorvastatin Calcium
Lisinopril
Adalimumab
Losartan
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