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Obinutuzumab for Kidney Disease (MAJESTY Trial)
MAJESTY Trial Summary
This trial will compare the effectiveness, safety, and drug properties of two drugs for primary membranous nephropathy, a kidney disease.
MAJESTY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMAJESTY Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 229 Patients • NCT02264574MAJESTY Trial Design
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Who is running the clinical trial?
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- I have type 1 or type 2 diabetes.My kidney function is adequate based on tests.I have not had major surgery in the last 4 weeks.I do not have any severe illnesses that would stop me from joining the study.I have severe kidney problems and need dialysis or similar treatment.I haven't taken specific immune therapies or certain medications in the last 6 to 9 months.I currently have an active infection or had a major one recently.You are currently using drugs or alcohol heavily, or have done so in the past year.I cannot tolerate or am advised against the study's treatments.My kidney disease is caused by another health condition.Your urine protein levels have not decreased by at least 50% in the last 6 months before the study starts.My kidney biopsy confirmed I have primary membranous nephropathy.My urine protein levels are high despite receiving supportive care for months.
- Group 1: Open Label Treatment: Obinutuzumab
- Group 2: Open Label Treatment: Tacrolimus
- 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.
- 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
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."
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."
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."
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."
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."
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"
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."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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