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Monoclonal Antibodies

Obinutuzumab for Kidney Disease (MAJESTY 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
eGFR >= 40 mL/min/1.73m^2 or qualified endogenous creatinine clearance >= 40 mL/min/1.73m^2 based on 24-hour urine collection during screening
Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights

MAJESTY Trial Summary

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

Who is the study for?
This trial is for adults with primary membranous nephropathy, a kidney condition diagnosed by biopsy. Participants must have significant protein in their urine despite supportive care and adequate kidney function. Exclusions include pregnancy, recent major surgery, intolerance to study drugs, severe renal impairment or dialysis need, diabetes, certain prior treatments including anti-CD20 therapy or immunosuppressants within specified time frames before screening.Check my eligibility
What is being tested?
The trial tests the effectiveness and safety of Obinutuzumab against Tacrolimus in treating primary membranous nephropathy. It also examines how the body processes these drugs (pharmacodynamics) and their movement through the body (pharmacokinetics). Patients will receive additional medications like Methylprednisolone, Diphenhydramine, and Acetaminophen to manage reactions.See study design
What are the potential side effects?
Possible side effects may include allergic reactions to medication components such as Obinutuzumab or Tacrolimus; increased risk of infections due to immune system suppression; potential liver or kidney function changes; blood pressure variations; nausea; headaches; and other drug-specific adverse effects.

MAJESTY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney function is adequate based on tests.
Select...
My kidney biopsy confirmed I have primary membranous nephropathy.

MAJESTY Trial 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%
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%
Colorectal cancer
1%
Bronchopulmonary aspergillosis
1%
Malignant melanoma
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%
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

MAJESTY 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
Diphenhydramine
2002
Completed Phase 4
~1170
Acetaminophen
2017
Completed Phase 4
~2030
Methylprednisolone
2015
Completed Phase 4
~2280
Obinutuzumab
2015
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,270 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,592 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
What site did they apply to?
Loyola University Med Center

Why did patients apply to this trial?

To see research is a success.
PatientReceived no prior treatments
~52 spots leftby Dec 2025