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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, 4, 12, 26, 36, 50, 52, 64, 76 and early study discontinuation
Awards & highlights
REGENCY Trial Summary
This trial will study if the addition of obinutuzumab to MMF & corticosteroids improves kidney function in patients with severe lupus nephritis.
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.Check my eligibility
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.See study design
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.
REGENCY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 2, 4, 12, 26, 36, 50, 52, 64, 76 and early study discontinuation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, 4, 12, 26, 36, 50, 52, 64, 76 and early study discontinuation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with Complete Renal Response (CRR)
Secondary outcome measures
Change from Baseline in Total Peripheral B-Cell Count
Change in Anti-dsDNA Titer
Change in Complement C3
+13 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
REGENCY 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
~2370
Obinutuzumab
2015
Completed Phase 3
~3250
MMF
2012
Completed Phase 4
~1580
Methylprednisolone
2015
Completed Phase 4
~2280
Acetaminophen
2017
Completed Phase 4
~2030
Diphenhydramine
2002
Completed Phase 4
~1170
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,802 Total Patients Enrolled
5 Trials studying Lupus Nephritis
604 Patients Enrolled for Lupus Nephritis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,250 Total Patients Enrolled
6 Trials studying Lupus Nephritis
985 Patients Enrolled for Lupus Nephritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses that would stop me from joining the trial.I currently have an active infection or had a major one recently.I haven't taken specific immune therapies or certain medications in the last 9 months.My kidney biopsy shows I have a specific type of advanced lupus nephritis.The amount of protein in your urine is equal to or greater than 1 when measured over a 24-hour period.I cannot tolerate or am advised against the study's treatments.I have severe kidney problems or am on dialysis/need a kidney transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Obinutuzumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
For what purpose is Obinutuzumab most regularly prescribed?
"Obinutuzumab is often used to manage pain. This medication can also be effective at treating other conditions, particularly ulcerative colitis, varicella-zoster virus acute retinal necrosis, and subarachnoid block."
Answered by AI
Do Obinutuzumab clinical trials have a history of success?
"There are a total of 609 clinical trials that have not yet completed for Obinutuzumab. Out of these, 157 are in Phase 3. Most trial locations for Obinutuzumab are in Duarte, California; however, there are 22004 total sites running trials for Obinutuzumab."
Answered by AI
Will this trial be open to patients who are not yet 60 years old?
"People between 18-75 years old who meet the other inclusion criteria can apply to be part of this trial. There are 116 clinical trials for people under the age of 18 and 533 for 65+."
Answered by AI
Has Obinutuzumab been cleared by the FDA?
"Obinutuzumab has undergone extensive safety testing and it is estimated to be a safe medication."
Answered by AI
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