Trial Outcomes & Findings for Novel Therapies for Resistant FSGS (FONTII): Phase II Clinical Trial (NCT NCT00814255)
NCT ID: NCT00814255
Last Updated: 2016-07-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
baseline and 6 months
Results posted on
2016-07-11
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Novel Therapies for Resistant FSGS (FONTII): Phase II Clinical Trial
Baseline characteristics by cohort
| Measure |
Conservative Medical Therapy Plus Adalimumab
n=7 Participants
Conservative medical therapy plus adalimumab
Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days
|
Conservative Medical Therapy
n=7 Participants
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
n=7 Participants
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
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
21.9 years
n=5 Participants
|
15.6 years
n=7 Participants
|
15.8 years
n=5 Participants
|
17.8 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
white
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
2 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
hispanic
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
21 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Conservative Medical Therapy Plus Adalimumab
n=7 Participants
Conservative medical therapy plus adalimumab
Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days 0 out of 7
|
Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat
n=7 Participants
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 2 out of 7
|
Conservative Medical Therapy Plus Galactose
n=7 Participants
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 2 out of 7
|
|---|---|---|---|
|
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
|
0 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: No data were collected.
Patient Satisfaction Score Using the Treatment Satisfaction Questionnaire for Medication (TSQM Questionnaire)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 7 monthsOutcome measures
| Measure |
Conservative Medical Therapy Plus Adalimumab
n=7 Participants
Conservative medical therapy plus adalimumab
Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days 0 out of 7
|
Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat
n=7 Participants
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 2 out of 7
|
Conservative Medical Therapy Plus Galactose
n=7 Participants
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 2 out of 7
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
7 participants
|
7 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: No data were collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: No data were collected.
Outcome measures
Outcome data not reported
Adverse Events
Conservative Medical Therapy Plus Adalimumab
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Conservative Medical Therapy Plus Galactose
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conservative Medical Therapy Plus Adalimumab
n=7 participants at risk
Conservative medical therapy plus adalimumab
Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days
|
Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat
n=7 participants at risk
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
n=7 participants at risk
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
|
|---|---|---|---|
|
General disorders
hospitalization
|
42.9%
3/7 • Number of events 32 • 6 month treatment period and 6 month follow up period
Data collected based on patient reports and a review of laboratory data. Adverse events were classified by MeDRA 10.0
|
14.3%
1/7 • Number of events 9 • 6 month treatment period and 6 month follow up period
Data collected based on patient reports and a review of laboratory data. Adverse events were classified by MeDRA 10.0
|
14.3%
1/7 • Number of events 1 • 6 month treatment period and 6 month follow up period
Data collected based on patient reports and a review of laboratory data. Adverse events were classified by MeDRA 10.0
|
|
General disorders
Pregnancy
|
14.3%
1/7 • Number of events 1 • 6 month treatment period and 6 month follow up period
Data collected based on patient reports and a review of laboratory data. Adverse events were classified by MeDRA 10.0
|
0.00%
0/7 • 6 month treatment period and 6 month follow up period
Data collected based on patient reports and a review of laboratory data. Adverse events were classified by MeDRA 10.0
|
14.3%
1/7 • Number of events 1 • 6 month treatment period and 6 month follow up period
Data collected based on patient reports and a review of laboratory data. Adverse events were classified by MeDRA 10.0
|
Other adverse events
| Measure |
Conservative Medical Therapy Plus Adalimumab
n=7 participants at risk
Conservative medical therapy plus adalimumab
Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days
|
Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat
n=7 participants at risk
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
n=7 participants at risk
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
|
|---|---|---|---|
|
General disorders
Edema
|
85.7%
6/7 • Number of events 100 • 6 month treatment period and 6 month follow up period
Data collected based on patient reports and a review of laboratory data. Adverse events were classified by MeDRA 10.0
|
85.7%
6/7 • Number of events 23 • 6 month treatment period and 6 month follow up period
Data collected based on patient reports and a review of laboratory data. Adverse events were classified by MeDRA 10.0
|
71.4%
5/7 • Number of events 57 • 6 month treatment period and 6 month follow up period
Data collected based on patient reports and a review of laboratory data. Adverse events were classified by MeDRA 10.0
|
|
Infections and infestations
Infection
|
71.4%
5/7 • Number of events 49 • 6 month treatment period and 6 month follow up period
Data collected based on patient reports and a review of laboratory data. Adverse events were classified by MeDRA 10.0
|
57.1%
4/7 • Number of events 10 • 6 month treatment period and 6 month follow up period
Data collected based on patient reports and a review of laboratory data. Adverse events were classified by MeDRA 10.0
|
71.4%
5/7 • Number of events 20 • 6 month treatment period and 6 month follow up period
Data collected based on patient reports and a review of laboratory data. Adverse events were classified by MeDRA 10.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place