Trial Outcomes & Findings for Obinutuzumab in Primary FSGS (NCT NCT04983888)
NCT ID: NCT04983888
Last Updated: 2026-06-25
Results Overview
Measured using 24 hour urine collection reported in g/d
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline, 12 months, 24 months
Results posted on
2026-06-25
Participant Flow
\[Not Specified\]
\[Not Specified\]
Participant milestones
| Measure |
Obinutuzumab
Subjects will receive obinutuzumab intravenously at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
Obinutuzumab: Intravenously (IV) at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
|
|---|---|
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Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Obinutuzumab in Primary FSGS
Baseline characteristics by cohort
| Measure |
Primary Focal Segmental Glomerulosclerosis (FSGS)
n=20 Participants
Subjects with immunosuppression-dependent or immunosuppression/treatment-resistant primary FSGS or contraindication/patient refusal to take high dose corticosteroids, will receive obinutuzumab 1 gram on day 1 and 1 gram on day 15, given intravenously and then an identical course at 6 months.
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|---|---|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=20 Participants
|
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Age, Continuous
|
45.3 years
STANDARD_DEVIATION 17.5 • n=20 Participants
|
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Sex: Female, Male
Female
|
9 Participants
n=20 Participants
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Sex: Female, Male
Male
|
11 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
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1 Participants
n=20 Participants
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
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19 Participants
n=20 Participants
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|
Region of Enrollment
Israel
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1 Participants
n=20 Participants
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PRIMARY outcome
Timeframe: Baseline, 12 months, 24 monthsMeasured using 24 hour urine collection reported in g/d
Outcome measures
| Measure |
Obinutuzumab
n=20 Participants
Subjects will receive obinutuzumab intravenously at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
Obinutuzumab: Intravenously (IV) at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
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|---|---|
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Change in Proteinuria
Proteinuria at baseline
|
10.7 g/d
Inter-Quartile Range 7.5 to 13.7 • Interval 7.5 to 13.7
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|
Change in Proteinuria
Proteinuria at 12 months
|
3.9 g/d
Inter-Quartile Range 1.5 to 8.6 • Interval 1.5 to 8.6
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Change in Proteinuria
Proteinuria at 24 months
|
1.1 g/d
Inter-Quartile Range 0.5 to 5.9 • Interval 0.5 to 5.9
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SECONDARY outcome
Timeframe: 12 monthsThe number of subjects to reach either complete remission or partial remission at 12 months after infusion. Complete remission defined as proteinuria \< 0.3g/24 hrs. and no more than 20% decline in eGFR. Partial remission defined as 50% reduction in proteinuria and proteinuria \< 3.5 g/24hrs and no more than 20% decline in eGFR.
Outcome measures
| Measure |
Obinutuzumab
n=20 Participants
Subjects will receive obinutuzumab intravenously at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
Obinutuzumab: Intravenously (IV) at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
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|---|---|
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Remission Status at 12 Months
|
9 Participants
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SECONDARY outcome
Timeframe: Baseline, 12 months, 24 monthsBlood serum collected and reported in g/dL
Outcome measures
| Measure |
Obinutuzumab
n=20 Participants
Subjects will receive obinutuzumab intravenously at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
Obinutuzumab: Intravenously (IV) at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
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|---|---|
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Change in Serum Albumin
Serum albumin at baseline
|
2.5 g/dL
Standard Deviation 0.6
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|
Change in Serum Albumin
Serum albumin at 12 months
|
3.5 g/dL
Standard Deviation 0.8
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Change in Serum Albumin
Serum albumin at 24 months
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3.9 g/dL
Standard Deviation 0.7
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SECONDARY outcome
Timeframe: 24 monthsNumber of subjects to experience serious adverse events including serious infection defined as severe UTI or pyelonephritis, pneumonias or other systemic infections requiring hospitalization
Outcome measures
| Measure |
Obinutuzumab
n=20 Participants
Subjects will receive obinutuzumab intravenously at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
Obinutuzumab: Intravenously (IV) at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
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|---|---|
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Serious Adverse Events (SAEs)
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3 Serious Adverse Events
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SECONDARY outcome
Timeframe: 18 monthsMeasured using 24 hour urine collection reported in g/d
Outcome measures
| Measure |
Obinutuzumab
n=20 Participants
Subjects will receive obinutuzumab intravenously at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
Obinutuzumab: Intravenously (IV) at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
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|---|---|
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Proteinuria at 18 Months
|
2.7 g/d
Interval 0.8 to 5.6
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SECONDARY outcome
Timeframe: 24 monthsMeasured using 24 hour urine collection reported in g/d
Outcome measures
| Measure |
Obinutuzumab
n=20 Participants
Subjects will receive obinutuzumab intravenously at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
Obinutuzumab: Intravenously (IV) at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
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|---|---|
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Proteinuria at 24 Months
|
1.1 g/d
Interval 0.6 to 5.5
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Adverse Events
Obinutuzumab
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Obinutuzumab
n=20 participants at risk
Subjects will receive obinutuzumab intravenously at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
Obinutuzumab: Intravenously (IV) at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
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|---|---|
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Psychiatric disorders
suicidal ideation
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5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Psychiatric disorders
pseudo-seizures
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5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Blood and lymphatic system disorders
follicular lymphoma
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5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Other adverse events
| Measure |
Obinutuzumab
n=20 participants at risk
Subjects will receive obinutuzumab intravenously at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
Obinutuzumab: Intravenously (IV) at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6.
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|---|---|
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General disorders
Brittle fingernails
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Fatigue
|
50.0%
10/20 • Number of events 10 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Lightheadedness
|
25.0%
5/20 • Number of events 5 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Musculoskeletal and connective tissue disorders
Joint Stiffness
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Hair loss
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Body numbness
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Infections and infestations
Covid-19
|
20.0%
4/20 • Number of events 4 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Blood and lymphatic system disorders
Worsening Anemia
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Shortness of breath
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Respiratory, thoracic and mediastinal disorders
Congestion
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Nausea
|
60.0%
12/20 • Number of events 13 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Vomiting
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25.0%
5/20 • Number of events 5 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Mouth Ulcers
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5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Fever
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Bradycardia during infusion
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10.0%
2/20 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Nervous system disorders
Headache
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35.0%
7/20 • Number of events 7 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Eye disorders
Blurred vision
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Infections and infestations
Shingles
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5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Hypertension during infusion
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Skin and subcutaneous tissue disorders
Body itching
|
20.0%
4/20 • Number of events 4 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Vascular disorders
Increased blood pressure
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5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Nervous system disorders
Forgetfulness
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5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Metabolism and nutrition disorders
Decreased appetite
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5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Musculoskeletal and connective tissue disorders
Physical weakness
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5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Nervous system disorders
Unsteady gait
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5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Dysphonia
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5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Cardiac disorders
Bradycardia
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Chills
|
20.0%
4/20 • Number of events 4 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Metabolism and nutrition disorders
Weight loss
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Eye disorders
Eye swelling
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Renal and urinary disorders
Dysuria
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Musculoskeletal and connective tissue disorders
Muscle Soreness
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10.0%
2/20 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Sore throat
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Teeth Soreness
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Cardiac disorders
Tachycardia
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Chest tightness
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Social circumstances
Increased anxiety
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Restless legs
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Facial flushing
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
|
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General disorders
Stomach pain
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Infections and infestations
Pneumonia
|
10.0%
2/20 • Number of events 3 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Blood and lymphatic system disorders
Swollen lymph nodes
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Infections and infestations
Thrush
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
|
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Infections and infestations
Upper respiratory infection
|
10.0%
2/20 • Number of events 3 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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General disorders
Night sweats
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
|
|
Infections and infestations
Flu like symptoms
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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|
Renal and urinary disorders
Fluid overload
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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|
Musculoskeletal and connective tissue disorders
Hip pain
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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Infections and infestations
Influenza A
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place