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Monoclonal Antibodies
Obinutuzumab for Focal Segmental Glomerulosclerosis
Phase 2
Waitlist Available
Led By Fernando Fervenza, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Biopsy proven Focal Segmental Glomerulosclerosis (FSGS) lesion
Presence of nephrotic syndrome (proteinuria > 3.5g/24hrs and serum albumin < 3.5 g/dl) prior to initiation of immunosuppressive therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months, 12 months
Awards & highlights
Study Summary
This trial will study if Obinutuzumab is safe and if it can help reduce the amount of protein in urine for people with proteinuria.
Who is the study for?
Adults with FSGS, a kidney disease causing protein loss in urine and low blood albumin levels. Participants must have tried other treatments without success or cannot take high-dose steroids. Excluded are those with genetic FSGS, infections like hepatitis or HIV, pregnant/breastfeeding women, severe anemia or low platelets, and recent recipients of certain drugs.Check my eligibility
What is being tested?
The trial is testing Obinutuzumab's ability to reduce proteinuria (protein in urine) for patients with primary FSGS. It aims to see if the drug can induce complete or partial remission of this condition.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, increased risk of infections due to immune system suppression, possible liver issues indicated by changes in blood tests results, fatigue and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney biopsy showed FSGS.
Select...
I have nephrotic syndrome with high protein in urine and low blood albumin levels.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in proteinuria
Secondary outcome measures
Change in serum albumin
Proteinuria at 18 months
Proteinuria at 24 months
+3 moreSide effects data
From 2019 Phase 3 trial • 229 Patients • NCT0226457444%
Neutropenia
35%
Thrombocytopenia
35%
Diarrhea
29%
Cough
24%
Arthralgia
23%
Infusion related reaction
19%
Fatigue
19%
Back pain
19%
Hypertension
17%
Anaemia
17%
Constipation
17%
Pyrexia
16%
Upper respiratory tract infection
15%
Rash maculo-papular
14%
Muscle spasms
14%
Atrial fibrillation
13%
Hyperuricaemia
13%
Nausea
13%
Nasopharyngitis
12%
Insomnia
12%
Urinary tract infection
12%
Oedema peripheral
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Dyspnoea
11%
Vomiting
11%
Pain in extremity
11%
Dizziness
10%
Cataract
10%
Decreased appetite
9%
Spontaneous haematoma
9%
Anxiety
9%
Fall
9%
Rash
8%
Iron deficiency
8%
Headache
8%
Abdominal pain
8%
Dyspepsia
8%
Vision blurred
8%
Pruritus
7%
Bronchitis
7%
Lacrimation increased
7%
Respiratory tract infection
7%
Blood creatine increased
7%
Productive cough
7%
Oropharyngeal pain
7%
Gastrooesophageal reflux disease
6%
Hypokalaemia
6%
Dry eye
6%
Chills
6%
Myalgia
6%
Depression
6%
Dry Skin
6%
Ecchymosis
6%
Onychoclasis
6%
Palpitations
6%
Stomatitis
6%
Peripheral swelling
6%
Epistaxis
5%
Herpes zoster
5%
Increased tendency to bruise
5%
Hyperglycaemia
5%
Musculoskeletal pain
5%
Haematuria
5%
Petechiae
5%
Cellulitis
5%
Contusion
4%
Tremor
4%
Febrile neutropenia
3%
Acute coronary syndrome
3%
Adenocarcinoma of colon
3%
Gastroenteritis
3%
Weight decreased
2%
Septic shock
2%
Femur fracture
2%
Osteoarthritis
2%
Transient ischaemic attack
2%
Cardiac arrest
2%
Angina pectoris
2%
Death
2%
Cerebrovascular accident
2%
Acute kidney injury
2%
Renal failure
1%
Bronchopulmonary aspergillosis
1%
Malignant melanoma
1%
Colorectal cancer metastatic
1%
Invasive ductal breast carcinoma
1%
Myelodysplastic syndrome
1%
Ischaemic stroke
1%
Uterine prolapse
1%
Bronchitis chronic
1%
Haemoptysis
1%
Oesophageal rupture
1%
Acute myocardial infarction
1%
Leukopenia
1%
Colorectal cancer
1%
Concussion
1%
Inclusion body myositis
1%
Peripheral ischaemia
1%
Arthritis
1%
Non-small cell lung cancer
1%
Compartment syndrome
1%
Respiratory failure
1%
Pleural effusion
1%
Cardiac failure congestive
1%
Gastritis
1%
Bacterial sepsis
1%
Pericarditis
1%
Stress cardiomyopathy
1%
Goitre
1%
Haemorrhoids
1%
Impaired gastric emptying
1%
Proctitis
1%
Small intestinal obstruction
1%
Catheter site haematoma
1%
Multi-organ disorder
1%
Cholelithiasis
1%
Abscess
1%
Bursitis infective staphylococcal
1%
Erysipelas
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Infective aneurysm
1%
Listeria sepsis
1%
Lower respiratory tract infection
1%
Pneumocystis jirovecii pneumonia
1%
Pneumonia bacterial
1%
Pneumonia klebsiella
1%
Prostate infection
1%
Sinusitis fungal
1%
Urosepsis
1%
Jaw fracture
1%
Pubis fracture
1%
Rib fracture
1%
Spinal compression fracture
1%
Thoracic vertebral fracture
1%
Traumatic haematoma
1%
Upper limb fracture
1%
Diabetes mellitus inadequate control
1%
Adenocarcinoma gastric
1%
Basal cell carcinoma
1%
Benign renal neoplasm
1%
Squamous cell carcinoma
1%
Syncope
1%
Acute psychosis
1%
Complete Suicide
1%
Soft tissue infection
1%
Osteoma
1%
Atrial tachycardia
1%
Retinal detachment
1%
Herpes Zoster
1%
Oral herpes
1%
Pharyngitis
1%
Streptococcal bacteraemia
1%
Cardiac failure
1%
Myocardial infarction
1%
Sudden Death
1%
Incisional hernia
1%
Hypercalcaemia
1%
Hypomagnesaemia
1%
Aplastic anaemia
1%
Inguinal hernia
1%
Large intestine polyp
1%
Cerebral ischaemia
1%
Depressed level of consciousness
1%
Confusional state
1%
Nephrolithiasis
1%
Urinary retention
1%
Benign prostatic hyperplasia
1%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
IBR+OB
CLB+OB
Trial Design
1Treatment groups
Experimental Treatment
Group I: Primary Focal Segmental Glomerulosclerosis (FSGS)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2015
Completed Phase 3
~3250
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,764 Total Patients Enrolled
1 Trials studying Primary Focal Segmental Glomerulosclerosis
9 Patients Enrolled for Primary Focal Segmental Glomerulosclerosis
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,669 Total Patients Enrolled
1 Trials studying Primary Focal Segmental Glomerulosclerosis
9 Patients Enrolled for Primary Focal Segmental Glomerulosclerosis
Fernando Fervenza, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your hemoglobin level is less than 8.0 grams per deciliter.I agree to use highly effective contraception during and 6 months after treatment.My kidney biopsy showed FSGS.My condition hasn't improved with standard treatments, or I can't take high dose steroids.I have nephrotic syndrome with high protein in urine and low blood albumin levels.Your kidney cells show a specific type of damage when viewed under a special microscope.I have had a kidney transplant.I currently have an infection.You have been diagnosed with hepatitis B, hepatitis C, or HIV.My kidney disease is due to genetic reasons or another condition.I am 18 years old or older.Your platelet count is less than 100,000.I do not have any health conditions that would make it unsafe for me to take a new drug.I have not taken cyclophosphamide in the last 6 months.I have taken rituximab before and my CD20 count is below 5 cells/microliter now.
Research Study Groups:
This trial has the following groups:- Group 1: Primary Focal Segmental Glomerulosclerosis (FSGS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently opportunities to join this research endeavor?
"Affirmative, the information hosted on clinicaltrials.gov confirms that this medical experiment is actively recruiting candidates. It was initially posted on November 17th 2021 and most recently updated August 26th 2022. A total of 20 patients must be recruited from a single site for completion of the trial."
Answered by AI
Could you provide details about previous Obinutuzumab experiments?
"Currently, there are 100 studies exploring the therapeutic potential of Obinutuzumab with 18 trials being in Phase 3. Investigations into this drug is happening across 4852 sites worldwide, though many of these clinical trials can be found close to La Jolla, California."
Answered by AI
Has the regulatory body accepted Obinutuzumab for use?
"By our team's assessment, obinutuzumab has achieved a score of 2 on the safety scale. This is due to its Phase 2 status which implies that while there are some findings in support of safety, efficacy remains unverified."
Answered by AI
Is this research project a pioneering endeavor?
"Currently, there are 100 active clinical trials using Obinutuzumab spanning 46 countries and 948 cities. Since the initial trial for this drug, sponsored by Genentech Inc., was conducted in 2014 and involved 40 participants to complete its Phase 1 & 2 approval stage, a further 55 studies have been completed."
Answered by AI
How many participants is the trial enrolling at this time?
"Affirmative. According to data posted on clinicaltrials.gov, this medical examination is currently recruiting participants having been first released on November 17th 2021. Its most recent update was August 26th 2022 and it requires 20 patients to be enrolled at a single site for the trial's completion."
Answered by AI
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