What side effects are associated with this type of intervention?

Common treatments for Lupus Nephritis, including mycophenolate mofetil (MMF), corticosteroids, and B cell depleting agents like rituximab, have several known side effects. MMF can cause gastrointestinal symptoms, infections, and bone marrow suppression. Corticosteroids are associated with weight gain, hypertension, diabetes, osteoporosis, and increased risk of infections. B cell depleting agents, such as rituximab and obinutuzumab, can lead to infusion reactions, infections, and potential reactivation of hepatitis B. It is crucial for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Lupus Nephritis, including drugs that target B cells via CD20. Rituximab, a monoclonal antibody that depletes B cells by targeting CD20, has been used off-label for Lupus Nephritis. More recently, Belimumab, a monoclonal antibody that inhibits B-cell activating factor (BAFF), was approved for Lupus Nephritis. These treatments aim to reduce the activity of B cells, which play a crucial role in the pathogenesis of Lupus Nephritis.

What other types of research exist?

Promising alternatives to Obinutuzumab for Lupus Nephritis include Rituximab (another CD20-targeting monoclonal antibody), Eculizumab (a complement inhibitor), and Avacopan (a C5a receptor antagonist).

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Corticosteroid

Obinutuzumab + Standard Therapy for Lupus Nephritis (REGENCY Trial)

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Known active infection of any kind or recent major episode of infection

Intolerance or contraindication to study therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial tests if adding obinutuzumab to standard treatments is safe and effective for patients with severe kidney inflammation from lupus. It helps the immune system remove harmful cells and has shown better results in kidney health compared to standard treatments alone.

Who is the study for?

This trial is for patients with Class III or IV lupus nephritis, as confirmed by a biopsy within the last 6 months. Participants must have significant protein in their urine and can't be pregnant, breastfeeding, or have received certain other treatments recently. They also shouldn't have severe kidney issues requiring dialysis or transplant.

What is being tested?

The study tests Obinutuzumab's effectiveness and safety against a placebo in patients with specific types of lupus nephritis. All participants will receive standard care including MMF and corticosteroids alongside the test drug or placebo.

What are the potential side effects?

Possible side effects include reactions to infusion like fever and chills, low blood cell counts increasing infection risk, potential liver damage indicated by blood tests, allergic reactions, and side effects from steroids such as mood changes.

Eligibility Criteria

Exclusion Criteria

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

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I currently have an active infection or had a major one recently.

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I cannot tolerate or am advised against the study's treatments.

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I have severe kidney problems or am on dialysis/need a kidney transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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 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

Bronchopulmonary aspergillosis

Compartment syndrome

Inclusion body myositis

Myelodysplastic syndrome

Ischaemic stroke

Malignant melanoma

Gastritis

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ObinutuzumabExperimental Treatment6 Interventions

Participants will be randomized into 2 groups. Group 1 will receive obinutuzumab 1000 mg IV at baseline and Weeks 2, 24, 26, 50, and 52 plus MMF and oral prednisone. Group 2 receive obinutuzumab 1000 mg IV at baseline and Weeks 2, 24, 26, and 52 plus MMF and oral prednisone. Group 2 participants will receive a placebo infusion at their Week 50 visit. Participants with an adequate response at Week 76 will continue receiving blinded obinutuzumab infusions every 6 months starting at Week 80. Participants without an adequate response at Week 76 may be eligible for open-label obinutuzumab starting at Week 80.

Group II: PlaceboPlacebo Group7 Interventions

Placebo participants will receive obinutuzumab matched placebo at baseline and Weeks 2, 24, 26, 50, and 52 plus MMF and oral prednisone. Participants with an adequate response at Week 76 will continue receiving blinded obinutuzumab infusions every 6 months starting at Week 80. Participants without an adequate response at Week 76 may be eligible for open-label obinutuzumab starting at Week 80.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500

Obinutuzumab

2014

Completed Phase 3

~3470

MMF

2012

Completed Phase 4

~1580

Methylprednisolone

2015

Completed Phase 4

~2280

Acetaminophen

2017

Completed Phase 4

~2030

Diphenhydramine

2002

Completed Phase 4

~1170

0 / 3Eligibility 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

Lupus Nephritis (LN) treatments often target the immune system to reduce inflammation and prevent kidney damage. Obinutuzumab, a monoclonal antibody, depletes B cells by targeting the CD20 protein, which is crucial because B cells play a significant role in the autoimmune response seen in LN. By reducing B cell activity, Obinutuzumab helps to decrease the production of autoantibodies that attack the kidneys. Standard treatments like mycophenolate mofetil (MMF) and corticosteroids also modulate the immune response; MMF inhibits lymphocyte proliferation, while corticosteroids reduce overall inflammation. These mechanisms are vital for LN patients as they help to control disease activity, prevent flares, and protect kidney function.