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Felzartamab for IgA Nephropathy (IGNAZ Trial)
IGNAZ Trial Summary
This trial is testing a new drug for IgA Nephropathy, a kidney disease. The trial is comparing the new drug to a placebo, and is double-blind, meaning neither the patients nor the researchers know who is receiving which treatment.
IGNAZ Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowIGNAZ 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 2020 Phase 1 & 2 trial • 91 Patients • NCT01421186IGNAZ Trial Design
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Who is running the clinical trial?
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- Your hemoglobin level is less than 90 grams per liter.Your neutrophil count is less than 1.5 x 10^9/L.Your liver enzymes are higher than the normal range.I am between 18 and 80 years old and of legal age.You have high levels of protein in your urine during the screening visit.Your white blood cell count is less than 3.0 x 10^9/L.I have type 1 diabetes.I've been on the highest dose possible of ACEi or ARB for my blood pressure for over 3 months.I am not pregnant or breastfeeding and agree to use contraception as advised for 3 months after the last treatment.Your platelet count is less than 100 billion per liter.My kidney disease (IgAN) was confirmed by a biopsy in the last 8 years.
- Group 1: Placebo
- Group 2: Felzartamab Arm #3
- Group 3: Felzartamab Arm #2
- Group 4: Felzartamab Arm #1
- 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
If I meet the requirements, may I sign up for this clinical trial?
"The requirements to join this clinical trial are that patients must have some form of kidney disease and be between 18-80 years old. Right now, the research team is seeking a total of 48 individuals."
Does this trial have an age limit? If so, what is it?
"This particular trial is only for patients that fall in the age range of 18 to 80 years old. In contrast, there are 45 trials recruiting patients under 18 and another 470 trials seeking participants over 65."
How does this new Felzartamab research compare to other scholarly work in the field?
"The first clinical trial for felzartamab occurred in 2019 at Peking Union Medical College Hospital. As of now, there are a total of 18290 completed clinical trials. Out of these, 7 are actively recruiting patients with many of these studies taking place in El Paso, Texas."
How many guinea pigs are part of this test group?
"The sponsor, MorphoSys AG, needs a total of 48 patients that fit the bill in order to carry out this trial. The study will be conducted at different sites including MedResearch INC in El Paso, Texas and FOMAT Medical Research - FOMAT - HyperCore - PPDS in Oxnard, California."
Are there still room for more participants in this research?
"The trial is still enrolling patients, as seen on clinicaltrials.gov. The original posting date was 8/31/2021, with the most recent update being 7/1/2022."
Is this research study the first to ever explore this treatment option?
"I-Mab Biopharma Co. Ltd.'s 2019 Phase 2 clinical trial was the first study involving Felzartamab. 113 patients completed the drug approval process in that year. Since then, 18290 studies have been conducted across 21 countries and 68 cities."
Does the FDA approve of Felzartamab?
"Felzartamab's safety is based on Phase 2 trial data, which only provides limited support for its use."
Is this study popular in Canadian hospitals?
"There are 4 enrolling patients for this clinical trial including MedResearch INC in El Paso, FOMAT Medical Research - FOMAT - HyperCore - PPDS in Oxnard, and Amicis Research Center, Vacaville in Vacaville. There are also 4 other locations where this study is taking place."
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