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Monoclonal Antibodies

Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)

Phase 1
Waitlist Available
Research Sponsored by FibroGen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

The purpose of this study is to evaluate the safety and tolerability of FG-3019 administered over 8 weeks to adolescent and adult subjects with steroid-resistant focal segmental glomerulosclerosis (FSGS).

Eligible Conditions
  • Focal Segmental Glomerulosclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2021 Phase 1 & 2 trial • 37 Patients • NCT02210559
75%
Fatigue
71%
Nausea
67%
Alopecia
58%
Oedema peripheral
50%
Diarrhoea
50%
Decreased appetite
42%
Vomiting
42%
Neuropathy peripheral
38%
Neutropenia
38%
Anaemia
33%
Platelet count decreased
33%
Dyspnoea
33%
Epistaxis
29%
Pyrexia
29%
Constipation
29%
Neutrophil count decreased
29%
Peripheral sensory neuropathy
29%
Rash
25%
Abdominal pain
25%
Cough
25%
Alanine aminotransferase increased
25%
Myalgia
25%
Dysgeusia
21%
Chills
21%
Rash maculo-papular
21%
Upper respiratory tract infection
21%
Cellulitis
21%
Aspartate aminotransferase increased
21%
Dizziness
17%
Blood alkaline phosphatase increased
17%
Hypokalaemia
17%
Night sweats
13%
Stomatitis
13%
Vision blurred
13%
Gait disturbance
13%
Urinary tract infection
13%
Rhinorrhoea
13%
Hyperhidrosis
13%
Pulmonary embolism
13%
Abdominal distension
13%
Fall
13%
Arthralgia
13%
Back pain
13%
Dehydration
13%
Depression
13%
Pulmonary toxicity
13%
Pancreatic insufficiency
13%
Headache
13%
Insomnia
8%
Thrombophlebitis superficial
8%
Deep vein thrombosis
8%
Productive cough
8%
Anxiety
8%
Pneumonia
8%
Dry eye
8%
Nasal congestion
8%
Muscle spasms
8%
Dry mouth
8%
Asthenia
8%
Blood creatinine increased
8%
Weight decreased
8%
Nocturia
8%
Pleural effusion
8%
Hypertension
8%
Thrombocytopenia
8%
Sinus tachycardia
8%
Tachycardia
8%
Dyspepsia
4%
Non-cardiac chest pain
4%
Haemorrhoids
4%
Craniocerebral injury
4%
Lymphadenopthy
4%
Pancreatitis
4%
Influenza like illness
4%
White blood cell count decreased
4%
Hyperglycaemia
4%
Ascites
4%
Haemolytic uraemic syndrome
4%
Drug withdrawal syndrome
4%
Pneumonitis
4%
Rash pustular
4%
Musculoskeletal pain
4%
Upper-airway cough syndrome
4%
Nail discolouration
4%
Pruritus
4%
Urticaria
4%
Hypoaesthesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: FG-3019Experimental Treatment1 Intervention
FG-3019 5 mg/kg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pamrevlumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

FibroGenLead Sponsor
58 Previous Clinical Trials
15,341 Total Patients Enrolled
~0 spots leftby Dec 2025
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