Trial · NCT00814255

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

NCT00814255, Phase 2, Completed, NYU Langone Health; results first posted 2016-07-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Novel Therapies for Resistant FSGS (FONTII): Phase II Clinical Trial. Trials, record NCT00814255. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00814255

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Novel Therapies for Resistant FSGS (FONTII): Phase II Clinical Trial
NCT number: NCT00814255
Status: Completed
Phases: Phase 2
Enrollment: 32 participants, actual
Lead sponsor: NYU Langone Health
Conditions: Focal Segmental Glomerulosclerosis
Interventions: Adalimumab, Lisinopril, losartan, and atorvastatin, galactose
First posted: 2008-12-24
Last updated: 2016-07-11
Results first posted: 2016-07-11
Limitations and caveats: 1. Limited sample size~2. Extended enrollment period~3. Replacement of rosiglitazone with galactose after start of trial

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
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	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	Patient Satisfaction Score Using the Treatment Satisfaction Questionnaire for Medication (TSQM Questionnaire)	Baseline and 6 months	Patient Satisfaction Score Using the Treatment Satisfaction Questionnaire for Medication (TSQM Questionnaire)
Secondary	Number of Participants With Adverse Events	Up to 7 months
Secondary	Percent Change in Proteinuria	Baseline and 6 months
Secondary	Percent Change in or Time to Doubling of Serum Creatinine	Baseline and 6 months

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
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	baseline and 6 months	One participant was assigned to the rosiglitazone arm before the drug was replaced with the galactose arm. This participant was not included in the analysis.	participants	NUMBER
SECONDARY	Patient Satisfaction Score Using the Treatment Satisfaction Questionnaire for Medication (TSQM Questionnaire)	Baseline and 6 months	No data were collected.
SECONDARY	Number of Participants With Adverse Events	Up to 7 months		participants	NUMBER
SECONDARY	Percent Change in Proteinuria	Baseline and 6 months	No data were collected.
SECONDARY	Percent Change in or Time to Doubling of Serum Creatinine	Baseline and 6 months	No data were collected.

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
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	Conservative Medical Therapy Plus Adalimumab	0	participants
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	Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat	2	participants
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	Conservative Medical Therapy Plus Galactose	2	participants
Number of Participants With Adverse Events	Conservative Medical Therapy Plus Adalimumab	7	participants
Number of Participants With Adverse Events	Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat	7	participants
Number of Participants With Adverse Events	Conservative Medical Therapy Plus Galactose	7	participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Conservative Medical Therapy Plus Adalimumab	8
Overall Study	STARTED	Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat	7
Overall Study	STARTED	Conservative Medical Therapy Plus Galactose	8
Overall Study	COMPLETED	Conservative Medical Therapy Plus Adalimumab	7
Overall Study	COMPLETED	Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat	7
Overall Study	COMPLETED	Conservative Medical Therapy Plus Galactose	7
Overall Study	NOT COMPLETED	Conservative Medical Therapy Plus Adalimumab	1
Overall Study	NOT COMPLETED	Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat	0
Overall Study	NOT COMPLETED	Conservative Medical Therapy Plus Galactose	1

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Edema	General disorders	Conservative Medical Therapy Plus Adalimumab	6	7	100
other	Edema	General disorders	Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat	6	7	23
other	Edema	General disorders	Conservative Medical Therapy Plus Galactose	5	7	57
other	Infection	Infections and infestations	Conservative Medical Therapy Plus Adalimumab	5	7	49
other	Infection	Infections and infestations	Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat	4	7	10
other	Infection	Infections and infestations	Conservative Medical Therapy Plus Galactose	5	7	20
serious	hospitalization	General disorders	Conservative Medical Therapy Plus Adalimumab	3	7	32
serious	hospitalization	General disorders	Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat	1	7	9
serious	hospitalization	General disorders	Conservative Medical Therapy Plus Galactose	1	7	1
serious	Pregnancy	General disorders	Conservative Medical Therapy Plus Adalimumab	1	7	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Conservative Medical Therapy Plus Adalimumab
Total, all-cause mortality	Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat
Total, all-cause mortality	Conservative Medical Therapy Plus Galactose
Total, other adverse events	Conservative Medical Therapy Plus Adalimumab	7	7
Total, other adverse events	Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat	7	7
Total, other adverse events	Conservative Medical Therapy Plus Galactose	7	7
Total, serious adverse events	Conservative Medical Therapy Plus Adalimumab	3	7
Total, serious adverse events	Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat	1	7
Total, serious adverse events	Conservative Medical Therapy Plus Galactose	1	7

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19073787	RESULT	PubMed
19932542	DERIVED	PubMed
21310077	DERIVED	PubMed
26198842	RESULT	PubMed
35224732	DERIVED	PubMed
40337980	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R33DK070341	Novel Therapies for Resistant FSGS	TRACHTMAN, HOWARD	NEW YORK UNIVERSITY SCHOOL OF MEDICINE	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2008 to 2011

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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