What is the mechanism of action of this treatment?

Primary Focal Segmental Glomerulosclerosis (FSGS) is often treated with immunosuppressive therapies to reduce inflammation and proteinuria. One such treatment is Obinutuzumab, a monoclonal antibody that targets CD20 on B cells, leading to their depletion. This is significant for FSGS patients because B cells play a role in the autoimmune response that contributes to kidney damage. By depleting B cells, Obinutuzumab can help reduce the immune-mediated attack on the kidneys, potentially leading to remission of proteinuria and preservation of kidney function.

What side effects are associated with this type of intervention?

Monoclonal antibodies targeting CD20, such as Obinutuzumab, are used to deplete B cells and can cause side effects including infusion-related reactions (fever, chills, hypotension), increased risk of infections due to immunosuppression, and potential hematologic toxicities like neutropenia. Other common treatments for FSGS, such as corticosteroids and immunosuppressive agents like cyclophosphamide, can also cause side effects including weight gain, hypertension, diabetes, gastrointestinal issues, and increased susceptibility to infections.

What prior FDA approvals exist?

The FDA has approved several treatments for Primary Focal Segmental Glomerulosclerosis (FSGS), primarily focusing on immunosuppressive therapies. Rituximab, another monoclonal antibody targeting CD20 on B cells, has been used off-label for FSGS due to its B cell-depleting properties. Other treatments include corticosteroids like prednisone and immunosuppressive agents such as cyclosporine and tacrolimus. These therapies aim to reduce proteinuria and slow disease progression by modulating the immune response.

What other types of research exist?

Promising novel alternatives to Obinutuzumab for Primary Focal Segmental Glomerulosclerosis (FSGS) patients include Rituximab, which has been studied for its efficacy in various kidney diseases, and Mycophenolate Mofetil (MMF), which is used as an immunosuppressive agent in high-risk patients. Additionally, investigational therapies such as targeted-release formulations of budesonide and calcineurin inhibitors (CNIs) are being explored for their potential benefits in treating FSGS.

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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

Must not have

For men: agreement to remain abstinent or use two adequate methods for contraception, including at least one method with failure rate of less than 1% per year during the treatment period and for at least 6 months (180 days) after the last dose of drug

Kidney transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called Obinutuzumab to see if it can help reduce protein levels in the urine of patients with kidney problems. The medication works by helping the immune system target and attack harmful cells. The goal is to find out if it is safe and effective for these patients.

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.

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.

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 below

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My kidney biopsy showed FSGS.

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I have nephrotic syndrome with high protein in urine and low blood albumin levels.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I agree to use highly effective contraception during and 6 months after treatment.

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I have had a kidney transplant.

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I currently have an infection.

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My kidney disease is due to genetic reasons or another condition.

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I have not taken cyclophosphamide in the last 6 months.

Select...

I have taken rituximab before and my CD20 count is below 5 cells/microliter now.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in proteinuria

Secondary study objectives

Change in serum albumin

Proteinuria at 18 months

Proteinuria at 24 months

+3 more

Side effects data

From 2019 Phase 3 trial • 229 Patients • NCT02264574

44%

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

Spontaneous haematoma

Anxiety

Fall

Rash

Headache

Iron deficiency

Abdominal pain

Dyspepsia

Vision blurred

Pruritus

Bronchitis

Lacrimation increased

Respiratory tract infection

Blood creatine increased

Productive cough

Oropharyngeal pain

Gastrooesophageal reflux disease

Hypokalaemia

Dry eye

Chills

Myalgia

Depression

Dry Skin

Ecchymosis

Onychoclasis

Palpitations

Stomatitis

Peripheral swelling

Epistaxis

Herpes zoster

Increased tendency to bruise

Hyperglycaemia

Musculoskeletal pain

Haematuria

Petechiae

Cellulitis

Contusion

Tremor

Febrile neutropenia

Adenocarcinoma of colon

Acute coronary syndrome

Gastroenteritis

Weight decreased

Septic shock

Femur fracture

Osteoarthritis

Transient ischaemic attack

Cardiac arrest

Angina pectoris

Death

Cerebrovascular accident

Acute kidney injury

Renal failure

Ischaemic stroke

Compartment syndrome

Inclusion body myositis

Malignant melanoma

Myelodysplastic syndrome

Gastritis

Bronchopulmonary aspergillosis

Respiratory failure

Peripheral ischaemia

Uterine prolapse

Bronchitis chronic

Haemoptysis

Oesophageal rupture

Colorectal cancer metastatic

Pleural effusion

Concussion

Invasive ductal breast carcinoma

Colorectal cancer

Non-small cell lung cancer

Cardiac failure congestive

Arthritis

Bacterial sepsis

Leukopenia

Acute myocardial infarction

Pericarditis

Stress cardiomyopathy

Goitre

Haemorrhoids

Impaired gastric emptying

Proctitis

Small intestinal obstruction

Catheter site haematoma

Multi-organ disorder

Cholelithiasis

Abscess

Bursitis infective staphylococcal

Erysipelas

Escherichia sepsis

Escherichia urinary tract infection

Infective aneurysm

Listeria sepsis

Lower respiratory tract infection

Pneumocystis jirovecii pneumonia

Pneumonia bacterial

Pneumonia klebsiella

Prostate infection

Sinusitis fungal

Urosepsis

Jaw fracture

Pubis fracture

Rib fracture

Spinal compression fracture

Thoracic vertebral fracture

Traumatic haematoma

Upper limb fracture

Diabetes mellitus inadequate control

Adenocarcinoma gastric

Basal cell carcinoma

Benign renal neoplasm

Squamous cell carcinoma

Syncope

Acute psychosis

Complete Suicide

Soft tissue infection

Osteoma

Atrial tachycardia

Retinal detachment

Herpes Zoster

Oral herpes

Pharyngitis

Streptococcal bacteraemia

Cardiac failure

Myocardial infarction

Sudden Death

Incisional hernia

Hypercalcaemia

Hypomagnesaemia

Aplastic anaemia

Inguinal hernia

Large intestine polyp

Cerebral ischaemia

Depressed level of consciousness

Confusional state

Nephrolithiasis

Urinary retention

Benign prostatic hyperplasia

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

IBR+OB

CLB+OB

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: 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

2014

Completed Phase 3

~3470

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Primary Focal Segmental Glomerulosclerosis (FSGS) is often treated with immunosuppressive therapies to reduce inflammation and proteinuria. One such treatment is Obinutuzumab, a monoclonal antibody that targets CD20 on B cells, leading to their depletion. This is significant for FSGS patients because B cells play a role in the autoimmune response that contributes to kidney damage. By depleting B cells, Obinutuzumab can help reduce the immune-mediated attack on the kidneys, potentially leading to remission of proteinuria and preservation of kidney function.