Monoclonal Antibodies

Obinutuzumab for Primary Membranous Nephropathy

Phase 3
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
Other inclusion criteria may apply
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 8 years
Awards & highlights
Approved for 50 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Study Summary

This trial will compare the effectiveness, safety, and drug properties of two drugs for primary membranous nephropathy, a kidney disease.

Eligible Conditions
  • Primary Membranous Nephropathy

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
There may be additional requirements for participation that are not listed here.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

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 Remission (CR) at Week 104
Secondary outcome measures
Change in anti-PLA2R Autoantibody Titer
Duration of CR
Incidence of ADAs during the study
+11 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%
Atrial fibrillation
14%
Muscle spasms
13%
Hyperuricaemia
13%
Nausea
13%
Nasopharyngitis
12%
Insomnia
12%
Urinary tract infection
12%
Oedema peripheral
11%
Asthenia
11%
Conjunctivitis
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%
Headache
8%
Abdominal pain
8%
Dyspepsia
8%
Vision blurred
8%
Iron deficiency
8%
Pruritus
7%
Lacrimation increased
7%
Bronchitis
7%
Respiratory tract infection
7%
Blood creatine increased
7%
Productive cough
7%
Oropharyngeal pain
7%
Gastrooesophageal reflux disease
6%
Dry eye
6%
Chills
6%
Myalgia
6%
Depression
6%
Dry Skin
6%
Ecchymosis
6%
Onychoclasis
6%
Palpitations
6%
Hypokalaemia
6%
Stomatitis
6%
Peripheral swelling
6%
Epistaxis
5%
Increased tendency to bruise
5%
Herpes zoster
5%
Hyperglycaemia
5%
Musculoskeletal pain
5%
Haematuria
5%
Petechiae
5%
Cellulitis
5%
Contusion
4%
Tremor
4%
Febrile neutropenia
3%
Gastroenteritis
3%
Adenocarcinoma of colon
3%
Weight decreased
3%
Acute coronary syndrome
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%
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%
Bacterial sepsis
1%
Bronchopulmonary aspergillosis
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%
Peripheral ischaemia
1%
Gastritis
1%
Soft tissue infection
1%
Osteoma
1%
Atrial tachycardia
1%
Retinal detachment
1%
Herpes Zoster
1%
Pharyngitis
1%
Oral herpes
1%
Streptococcal bacteraemia
1%
Concussion
1%
Cardiac failure
1%
Cardiac failure congestive
1%
Myocardial infarction
1%
Sudden Death
1%
Incisional hernia
1%
Hypercalcaemia
1%
Hypomagnesaemia
1%
Aplastic anaemia
1%
Leukopenia
1%
Acute myocardial infarction
1%
Inguinal hernia
1%
Large intestine polyp
1%
Oesophageal rupture
1%
Arthritis
1%
Compartment syndrome
1%
Inclusion body myositis
1%
Colorectal cancer
1%
Colorectal cancer metastatic
1%
Invasive ductal breast carcinoma
1%
Malignant melanoma
1%
Myelodysplastic syndrome
1%
Non-small cell lung cancer
1%
Cerebral ischaemia
1%
Depressed level of consciousness
1%
Ischaemic stroke
1%
Confusional state
1%
Nephrolithiasis
1%
Urinary retention
1%
Benign prostatic hyperplasia
1%
Uterine prolapse
1%
Bronchitis chronic
1%
Haemoptysis
1%
Pleural effusion
1%
Respiratory failure
1%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
IBR+OB
CLB+OB

Awards & Highlights

Approved for 50 Other Conditions
This treatment demonstrated efficacy for 50 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Open Label Treatment: ObinutuzumabExperimental Treatment4 Interventions
Participants will be randomized at a 1:1 ratio to receive open-label treatment with obinutuzumab according to region and anti-phospholipase A2 receptor (PLA2R) autoantibody titer (using Euroimmun ELISA).
Group II: Open Label Treatment: TacrolimusActive Control1 Intervention
Participants will be randomized at a 1:1 ratio to receive open-label treatment with tacrolimus according to region and anti-PLA2R autoantibody titer (using Euroimmun ELISA).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
FDA approved
Diphenhydramine
FDA approved
Methylprednisolone
FDA approved
Obinutuzumab
FDA approved

Find a site

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,406 Previous Clinical Trials
1,079,062 Total Patients Enrolled
Clinical TrialsStudy Director
Hoffmann-La Roche
2,183 Previous Clinical Trials
886,610 Total Patients Enrolled

Media Library

Obinutuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04629248 — Phase 3
Primary Membranous Nephropathy Research Study Groups: Open Label Treatment: Obinutuzumab, Open Label Treatment: Tacrolimus
Primary Membranous Nephropathy Clinical Trial 2023: Obinutuzumab Highlights & Side Effects. Trial Name: NCT04629248 — Phase 3
Obinutuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04629248 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we enrolling patients at this time for this research project?

"That is accurate. The clinical trial listed on clinicaltrials.gov is currently seeking patients. The earliest posting date was June 25th, 2021 with the most recent update being October 13th, 2022. A total of 140 patients are needed for the 17 sites participating in the study."

Answered by AI

Does this experiment only allow volunteers who are 30 years old or younger?

"According to the study's eligibility requirements, patients must be aged 18 to 75 to participate. Out of the 1,001 total clinical trials, 148 are for patients under 18 and 853 are for patients over 65."

Answered by AI

Is Obinutuzumab used more often for treatment or research?

"Obinutuzumab is typically used as a treatment for nephrotic syndrome. However, it can also be effective in treating conditions such as whiplash syndrome, ophthalmia, sympathetic ophthalmia, and scalp structure."

Answered by AI

When was Obinutuzumab approved by the FDA?

"There is both efficacy and safety data available for Obinutuzumab, as it has gone through multiple Phase 3 trials. This gives it a score of 3."

Answered by AI

Can you estimate how many different medical clinics are running this trial today?

"This clinical study is being conducted out of Penn State Univ. Milton S. Hershey Medical Center in Hershey, Pennsylvania, Accel Research Sites; Mid-Florida Kidney and Hypertension Care in Altamonte Springs, Florida, and North Shore University Hospital in Manhasset, New York. Additionally, there are 17 other locations where this trial is running."

Answered by AI

Does my health profile fit the parameters for this experiment?

"This medical study is looking for 140 patients that have been diagnosed with kidney disease. Participants must be between 18-75 years old and meet the following additional criteria: A diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening, Screening urinary protein-to-creatinine ratio (UPCR) >= 5 g/g from 24-hour urine collection after best supportive care for >= 3 months prior to screening or screening UPCR >= 4 g/g after best supportive care for >= 6 months prior to screening, eGFR >= 40 mL/min"

Answered by AI

What is the precedent for Obinutuzumab's clinical efficacy?

"There are a total of 494 trials ongoing for Obinutuzumab, with 99 of them being in the critical Phase 3. Most of the research is based in Philadelphia, although there are 12293 total locations running Obinutuzumab trials."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~50 spots leftby Jan 2025