Study Summary
This trial will study whether the drug obinutuzumab is safe and effective in treating adolescent patients with lupus nephritis.
Eligible Conditions
- Lupus Nephritis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 15 Secondary · Reporting Duration: Baseline, Weeks 4, 24, 52 and 76
Baseline to Week 76
Change from Baseline in Child Health Questionnaire-Parent Form 28 (CHQ-PF28) Domain Scores
Change in C3 Complement Levels
Change in C4 Complement Levels
Change in Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale (PedsQL)-Fatigue Total Score
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Change in UPCR
Change in eGFR
Percentage of Participants with Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Serum Concentrations of Obinutuzumab
Week 4
Percentage of Participants Achieving B-cell Depletion via Highly Sensitive Flow Cytometry (HSFC)
Up to Week 76
Time to Onset of CRR over the Course of 76 weeks
Week 76
Percentage of Participants who Experience Treatment Failure
Week 76
Percentage of Participants who Achieve a Complete Renal Response (CRR)
Percentage of Participants who Achieve a Partial Renal Response (PRR)
Weeks 24 and 52
Percentage of Participants Achieving a CRR
Week 24
Percentage of Participants Achieving an Overall Response (CRR or PRR)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
CLB+OB
63%Neutropenia
53%Infusion related reaction
30%Nausea
25%Anaemia
25%Thrombocytopenia
24%Pyrexia
17%Fatigue
15%Asthenia
13%Dyspnoea
12%Cough
12%Constipation
12%Vomiting
11%Headache
10%Arthralgia
10%Diarrhea
10%Back pain
9%Chills
9%Pain in extremity
8%Epistaxis
7%Anxiety
7%Oedema peripheral
6%Upper respiratory tract infection
6%Vision blurred
6%Urinary tract infection
6%Dizziness
6%Hyperglycaemia
6%Tremor
6%Febrile neutropenia
6%Muscle spasms
5%Abdominal pain
5%Oral herpes
5%Hypotension
5%Weight decreased
4%Pneumonia
4%Decreased appetite
4%Insomnia
4%Tumour lysis syndrome
4%Lacrimation increased
4%Hypertension
3%Musculoskeletal pain
3%Cellulitis
3%Gastrooesophageal reflux disease
3%Herpes zoster
3%Pruritus
3%Palpitations
3%Nasopharyngitis
3%Fall
3%Myalgia
3%Oropharyngeal pain
3%Dry eye
2%Peripheral swelling
2%Hypokalaemia
2%Sepsis
2%Dyspepsia
2%Conjunctivitis
2%Bronchitis
2%Productive cough
2%Rash maculo-papular
1%Hyponatraemia
1%Venous thrombosis limb
1%Craniocerebral injury
1%Acute myocardial infarction
1%Pericarditis constrictive
1%Chronic lymphocytic leukaemia
1%Essential thrombocythaemia
1%Keratoacanthoma
1%Urinary retention
1%Respiratory failure
1%Stomatitis
1%Gastroenteritis
1%Hip fracture
1%Accidental overdose
1%Dehydration
1%Kaposi's sarcoma
1%Neuroendocrine carcinoma of the skin
1%Loss of consciousness
1%Prostate Cancer
1%Seizure
1%Acute kidney injury
1%Acute respiratory failure
1%Pulmonary embolism
1%Cataract
1%Spontaneous haematoma
1%Blood creatine increased
1%Respiratory tract infection
1%Contusion
1%Depression
1%Rash
1%Myocardial ischaemia
1%Cholecystitis
1%Small intestinal obstruction
1%Vascular device infection
1%Pharyngitis
1%Concussion
1%Osteonecrosis of jaw
1%Osteolysis
Trial Design
2 Treatment Groups
Obinutuzumab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
30 Total Participants · 2 Treatment Groups
Primary Treatment: Obinutuzumab · Has Placebo Group · Phase 2
ObinutuzumabExperimental Group · 6 Interventions: Diphenhydramine hydrochloride (HCl), Mycophenolate Mofetil, Prednisone, Methylprednisolone, Acetaminophen/paracetamol, Obinutuzumab · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
PlaceboPlaceboComparator Group · 6 Interventions: Diphenhydramine hydrochloride (HCl), Placebo, Mycophenolate Mofetil, Prednisone, Methylprednisolone, Acetaminophen/paracetamol · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate mofetil
FDA approved
Prednisone
FDA approved
Methylprednisolone
FDA approved
Obinutuzumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, weeks 4, 24, 52 and 76
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,497 Previous Clinical Trials
564,586 Total Patients Enrolled
4 Trials studying Lupus Nephritis
630 Patients Enrolled for Lupus Nephritis
Hoffmann-La RocheLead Sponsor
2,360 Previous Clinical Trials
1,067,611 Total Patients Enrolled
5 Trials studying Lupus Nephritis
816 Patients Enrolled for Lupus Nephritis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,146 Previous Clinical Trials
875,665 Total Patients Enrolled
6 Trials studying Lupus Nephritis
1,197 Patients Enrolled for Lupus Nephritis
Eligibility Criteria
Age 12 - 17 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:During the 12 months prior to or during screening, all participants must have received at least one dose of a pulse-range IV methylprednisolone (typically 30 mg/kg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN.
The International Society of Nephrology and the Renal Pathology Society (ISN/RPS) recommends that individuals with Class III or IV active lupus nephritis demonstrated on a renal biopsy performed in the 12 months prior to or during screening be excluded from kidney transplantation.
A patient is diagnosed with SLE if they meet ≥4 of 11 criteria
You have a history of LN, but you do not have LN with a class III or IV disease.
Who else is applying?
What state do they live in?
| California | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of California San Francisco | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments