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Monoclonal Antibodies
Obinutuzumab for Lupus Nephritis (POSTERITY Trial)
Phase 2
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants who are age 12 to <18 years at the time of randomization
Participants who are age 5 to <12 years (younger participant cohort) at the time of randomization once recruitment is open
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 4, 24, 52 and 76
Awards & highlights
POSTERITY Trial Summary
This trial will study whether the drug obinutuzumab is safe and effective in treating adolescent patients with lupus nephritis.
Who is the study for?
Adolescents aged 12-17 with active Class III or IV Lupus Nephritis (LN) and children aged 5-11 for safety assessment can join this trial. They must have a biopsy confirming LN, meet specific criteria for protein in urine, and have received certain treatments for LN within the last year. Those with isolated Class V disease, severe other diseases, recent cancers, uncontrolled CNS SLE symptoms, drug abuse history or current infections cannot participate.Check my eligibility
What is being tested?
The study is testing Obinutuzumab's effectiveness and safety in treating Lupus Nephritis in adolescents compared to a placebo. It includes medications like Prednisone and Mycophenolate Mofetil as part of treatment regimens. The trial also assesses how the body processes Obinutuzumab in younger children.See study design
What are the potential side effects?
Possible side effects include reactions to infusion such as fever or chills; low blood cell counts leading to increased infection risk; potential liver issues indicated by blood tests; allergic reactions; and gastrointestinal discomfort.
POSTERITY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 17 years old.
Select...
I am between 5 and 11 years old.
Select...
I have been diagnosed with SLE as per the SLICC 2012 criteria.
POSTERITY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 4, 24, 52 and 76
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 4, 24, 52 and 76
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 who Achieve a Complete Renal Response (CRR) (AP)
Percentage of Participants with Adverse Events (PP)
Secondary outcome measures
Change from Baseline in Child Health Questionnaire-Parent Form 28 (CHQ-PF28) Domain Scores (AP)
Change in C3 Complement Levels (AP)
Change in C4 Complement Levels (AP)
+23 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%
Malignant melanoma
1%
Bronchopulmonary aspergillosis
1%
Ischaemic stroke
1%
Uterine prolapse
1%
Acute myocardial infarction
1%
Concussion
1%
Non-small cell lung cancer
1%
Invasive ductal breast carcinoma
1%
Leukopenia
1%
Arthritis
1%
Compartment syndrome
1%
Inclusion body myositis
1%
Colorectal cancer metastatic
1%
Myelodysplastic syndrome
1%
Bronchitis chronic
1%
Haemoptysis
1%
Oesophageal rupture
1%
Respiratory failure
1%
Colorectal cancer
1%
Peripheral ischaemia
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
POSTERITY Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-Label ObinutuzumabExperimental Treatment6 Interventions
Younger participants aged 5 to <12 will receive obinutuzumab 1000 mg IV infusions on Days 1, 14, Week 24, Week 26 and Week 52.
Group II: Blinded ObinutuzumabExperimental Treatment6 Interventions
Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1, Day 14, Week 24, Week 26 and Week 52. Participants with a body weight of 45 kg or more will receive the 1000 mg dose. Participants with a body weight below 45 kg will receive a weight adjusted dose of 20 mg/kilogram (kg).
Group III: PlaceboPlacebo Group6 Interventions
Placebo participants will receive obinutuzumab matched placebo on Day 1, Day 14, Week 24, Week 26 and Week 52.
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
Methylprednisolone
2015
Completed Phase 4
~2280
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,382 Total Patients Enrolled
5 Trials studying Lupus Nephritis
816 Patients Enrolled for Lupus Nephritis
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,859 Total Patients Enrolled
4 Trials studying Lupus Nephritis
630 Patients Enrolled for Lupus Nephritis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,692 Total Patients Enrolled
6 Trials studying Lupus Nephritis
1,197 Patients Enrolled for Lupus Nephritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe brain-related lupus symptoms like vision loss, uncontrolled seizures, confusion, or difficulty moving.I have not had a serious infection or been treated with IV or oral anti-infectives recently.You have a history of weak immune system or severe blood disorders.My kidney biopsy shows I have Class III or IV lupus nephritis.I have a history of serious, recurring infections.You have a specific type of lupus nephritis called Class V LN.I am between 12 and 17 years old.More than half of the kidney's glomeruli show signs of scarring on a biopsy.I cannot tolerate or am not allowed to have the study's treatments.I have not had any cancer except for treated skin cancer in the last 5 years.My kidney biopsy shows I only have chronic damage, with no active disease.I have a quickly worsening kidney condition.You are currently misusing alcohol or drugs, or have a history of misusing them.I do not have any severe illnesses that would stop me from joining the study.I am between 5 and 11 years old.I have Class III or IV kidney disease, and may also have Class V.I have been diagnosed with SLE as per the SLICC 2012 criteria.You have too much protein in your urine, based on a test done in the morning.I've had a strong steroid treatment for my lupus nephritis in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Open-Label Obinutuzumab
- Group 2: Blinded Obinutuzumab
- Group 3: Placebo
Awards:
This trial has 0 awards, including: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.
Is there still an opportunity for people to join this experimental endeavor?
"Confirmed. The clinical trial outlined on the clinicaltrials.gov is actively recruiting participants, having been posted in May of 2022 and recently updated in November of that same year. Recruitment requires 30 volunteers from 11 separate medical centres."
Answered by AI
What is the current number of participants in this research endeavor?
"Genentech, Inc., the sponsor of this trial, is calling for a minimum of 30 participants that meet enrollment requirements to execute their study. These individuals will be recruited from Nationwide Children's Hospital in Columbus and University of California San Francisco in San Francisco."
Answered by AI
What maladies has Obinutuzumab been utilized to combat?
"Obinutuzumab is frequently utilized to mitigate discomfort, but has also been found to posses efficacy in the treatment of conditions such as ulcerative colitis, varicella-zoster virus acute retinal necrosis, and subarachnoid block."
Answered by AI
Is this research endeavor open to individuals more than two decades of age?
"Those wishing to participate in this clinical trial must be between 12 and 17 years old. There are 168 trials geared towards minors while the elderly have access to 598 different studies."
Answered by AI
What is the number of medical centers participating in this research endeavor?
"This medical study is taking place at 11 different locations, such as Nationwide Children's Hospital in Columbus, University of California San Francisco in San Francisco and Children's Hospital Colorado, Anchutz Medical Campus in Aurora."
Answered by AI
Is it feasible for me to become a participant in this experimentation?
"This clinical trial is recruiting 30 juvenile patients with lupus nephritis, aged between 12 and 17. Notably these individuals must have either Class III or IV Lupus Nephritis, however those exhibiting solely Class V symptoms are not eligible for participation."
Answered by AI
Has Obinutuzumab been granted regulatory approval by the Food and Drug Administration?
"The safety of Obinutuzumab is ranked at a 2, as it has yet to be proven efficacious but there are some studies that suggest its security."
Answered by AI
What other evidence exists regarding the efficacy of Obinutuzumab?
"Currently, 698 active studies are exploring the efficacy of Obinutuzumab with 165 trials in phase 3. Although Philadelphia is home to multiple research sites running these clinical trials, there are over 20 thousand locations offering this medication globally."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
University of California San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
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