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

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00814255
First received: December 22, 2008
Last updated: July 1, 2016
Last verified: July 2016
Results First Received: September 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Focal Segmental Glomerulosclerosis
Interventions: Drug: Adalimumab
Drug: Lisinopril, losartan, and atorvastatin
Drug: galactose

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

32 patients consented however 8 were not assigned to treatment because they failed to meet eligibility at the end of the screening

1 patient was assigned to rosiglitazone and was not included in the analysis.


Reporting Groups
  Description
Conservative Medical Therapy Plus Adalimumab

Conservative medical therapy plus adalimumab

Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days

Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat

Conservative medical therapy (lisinopril, losartan, atorvastatin)

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

Conservative Medical Therapy Plus Galactose

drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID

galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID

NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose.


Participant Flow:   Overall Study
    Conservative Medical Therapy Plus Adalimumab     Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat     Conservative Medical Therapy Plus Galactose  
STARTED     8     7     8  
COMPLETED     7     7     7  
NOT COMPLETED     1     0     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Conservative Medical Therapy Plus Adalimumab

Conservative medical therapy plus adalimumab

Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days

Conservative Medical Therapy

Conservative medical therapy (lisinopril, losartan, atorvastatin)

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

Conservative Medical Therapy Plus Galactose

drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID

galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID

Total Total of all reporting groups

Baseline Measures
    Conservative Medical Therapy Plus Adalimumab     Conservative Medical Therapy     Conservative Medical Therapy Plus Galactose     Total  
Number of Participants  
[units: participants]
  7     7     7     21  
Age  
[units: participants]
       
<=18 years     5     5     4     14  
Between 18 and 65 years     2     2     3     7  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean (Full Range)
  21.9  
  (7.2 to 36.7)  
  15.6  
  (3.8 to 34.1)  
  15.8  
  (13 to 21)  
  17.8  
  (3.8 to 36.6)  
Gender  
[units: participants]
       
Female     4     4     4     12  
Male     3     3     3     9  
Race/Ethnicity, Customized  
[units: participants]
       
white     3     7     2     12  
hispanic     2     0     3     5  
African American     2     0     2     4  
Region of Enrollment  
[units: participants]
       
United States     7     7     7     21  



  Outcome Measures
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1.  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   [ Time Frame: baseline and 6 months ]

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  1. Limited sample size
  2. Extended enrollment period
  3. Replacement of rosiglitazone with galactose after start of trial


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Howard Trachtman
Organization: NYUmed
phone: 646-501-2663
e-mail: howard.trachtman@nyumc.org


Publications of Results:
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 ( US NIH Grant/Contract Award Number )
Study First Received: December 22, 2008
Results First Received: September 9, 2015
Last Updated: July 1, 2016
Health Authority: United States: Food and Drug Administration
United States: Federal Government