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New treatment option for Kidney Disease
Official title A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
ClinicalTrials.gov ID: NCT06963827
What this study is testing
What is Mezagitamab?
Mezagitamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for kidney disease.
Also referred to as TAK-079.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- To be eligible to participate in this trial, participants must meet all the following criteria:
- Either UPCR greater than or equal to (≥) 0.8 gram per gram (g/g) or urine protein excretion (UPE) ≥1 grams per day (g/day), calculated from at least...
- eGFR greater than (\>)30 milliliters per minute per 1.73 meter square (mL/min/1.73m\^2) at screening based on the Chronic Kidney Disease Epidemiology...
- No prior exposure to anti- cluster of differentiation 38 (CD38) therapy period (except for open-label cohort participants meeting Inclusion Criterion...
- The participant is aged ≥ 18 years or the local legal age as applicable.
You likely can't join if
- A participant who meets any of the following criteria will be excluded from participation in this trial:
- Kidney biopsy exhibiting significant concomitant renal disease other than IgAN (for example, diabetic nephropathy, lupus nephritis, minimal change...
- Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies), and immunoglobulin A...
- Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months before the signing of the ICF).
- Diagnosis of nephrotic syndrome defined as 24-hour proteinuria \>3.5 g/day and hypoalbuminemia (\<3.0 grams per deciliter [g/dL]) with or without...
- Renal or other organ transplantation prior to or expected during the clinical trial.
See the full eligibility criteria
Who can join
- To be eligible to participate in this trial, participants must meet all the following criteria:
- Either UPCR greater than or equal to (≥) 0.8 gram per gram (g/g) or urine protein excretion (UPE) ≥1 grams per day (g/day), calculated from at least one 24-hour urine collection during the screening period (or...
- eGFR greater than (\>)30 milliliters per minute per 1.73 meter square (mL/min/1.73m\^2) at screening based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (only applicable for the main trial).
- No prior exposure to anti- cluster of differentiation 38 (CD38) therapy period (except for open-label cohort participants meeting Inclusion Criterion No. 10.a).
- The participant is aged ≥ 18 years or the local legal age as applicable.
- The participant (and the participant's legally acceptable representative, as applicable per local regulations or determination) has provided informed consent (that is, in writing, documented via a signed and dated...
- Diagnosis of primary immunoglobulin A nephropathy (IgAN) supported by a renal biopsy report that is dated more recently than 10 years before the signing of the informed consent for the clinical trial. The redacted...
- Participants must be on stable renin-angiotensin-aldosterone system (RAAS) inhibitor therapy with an angiotensin-converting enzyme inhibitor (ACE-I) and/or angiotensin receptor blocker (ARB) or endothelin receptor...
- Resting blood pressure less than or equal to (≤)150 millimeters of mercury (mmHg) systolic and ≤100 mmHg diastolic.
- Female participants of childbearing potential who are not pregnant during screening (confirmed by negative serum human chorionic gonadotropin [hCG]) and on Visit 1 before first dose of trial intervention (confirmed by...
- Any one of the following (only applicable for participants in the open-label cohort):
- Participants in Trial TAK-079-1006 who completed the Week 96 visit or the retreatment period with either UPCR \>0.5 g/g or UPE \>0.5 g/d calculated from a 24-hour urine collection during the screening period (or...
- UPCR \ 30 mL/min/1.73m\^2 at screening based on the CKD-EPI formula.
- UPCR ≥ 0.8 g/g or UPE ≥ 1.0 g/d by 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR ≥25 and ≤30 mL/min/1.73m\^2 at screening based on the CKD-EPI formula.
What rules you out
- A participant who meets any of the following criteria will be excluded from participation in this trial:
- Kidney biopsy exhibiting significant concomitant renal disease other than IgAN (for example, diabetic nephropathy, lupus nephritis, minimal change disease).
- Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies), and immunoglobulin A (IgA) vasculitis.
- Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months before the signing of the ICF).
- Diagnosis of nephrotic syndrome defined as 24-hour proteinuria \>3.5 g/day and hypoalbuminemia (\<3.0 grams per deciliter [g/dL]) with or without peripheral edema.
- Renal or other organ transplantation prior to or expected during the clinical trial.
- Treatment with oral immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, cyclosporine, azathioprine, calcineurin inhibitors) or biologic therapy for immunomodulation (including immunomodulatory...
- If the participant has received anti-CD20 treatment, the participant is excluded if either of the following apply:
- The last dose was received within 6 months before the signing of the ICF.
- The last dose was received between 6 and 12 months before the signing of the ICF and the participant has a CD19+ count below the lower limit of normal. Note: Participants who have received the last dose of anti-CD20...
- Within 4 months of the screening visit, use of either a) systemic corticosteroids at an average dose of 40 milligrams (mg) prednisone equivalent or higher for more than 14 days or b) oral budesonide delayed release...
- The participant has received a live or live-attenuated vaccine within 4 weeks before signing the ICF or has any live or live-attenuated vaccine planned during the clinical trial.
- Participation in any other investigational drug trial (including vaccine trial) with receipt of at least 1 dose of investigational drug, or has been exposed to another investigational agent within 4 weeks or 5...
- The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- The participant has had any of the following types of infections within the specified timeframes where applicable:
- Active bacterial, viral, or fungal infection (except for the common cold and onychomycosis), or any other serious infection within 2 weeks of signing the ICF. Any anti-infective course for infection must be completed at...
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) infection within 4 weeks of signing the ICF.
- Opportunistic infection or treatment for an opportunistic infection less than or equal to (≤)12 weeks before signing the ICF.
- Active tuberculosis (TB), any history of prior active TB, or any signs or symptoms of active TB infection (including but not limited to chronic fever, chronic productive cough, night sweats, weight loss, or...
- For participants in European Union (EU) member states, positive or 2 indeterminant QuantiFERON results, unless there is documentation of prior complete treatment for latent TB, or participant has initiated prophylaxis...
- In the opinion of the investigator, the participant is currently experiencing any medical condition that might interfere with participation in the trial (for example, significant ocular, cardiovascular, pulmonary...
- In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment.
- The participant has a history of major surgery within 3 months before screening (or longer, at the discretion of the investigator); or, either has a planned tonsillectomy or underwent a tonsillectomy within 6 months...
- History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for adequately treated non-melanoma skin cancer, superficial bladder cancer, and curatively treated cervical...
- The participant has a history of a severe allergic or anaphylactic reaction to recombinant proteins or excipients used in the mezagitamab or placebo formulation.
- The participant has (1) been diagnosed with or has suspected chronic obstructive pulmonary disease (COPD) or asthma and (2) has a prebronchodilatory forced expiratory volume in 1 second (FEV1) \<50% of predicted normal...
- The participant is capable of breastfeeding but does not agree to forego breastfeeding from first dose of investigational medicinal product (IMP) through 30 days after the last dose of IMP.
- The participant is an individual with potential for pregnancy but does not agree to use at least 1 form of highly effective contraception and 1 barrier method of contraception (preferably male condom) when engaging in...
- The participant is a sexually active, non-sterilized individual who produces sperm but does not agree to use a barrier method (preferably male condom) combined with at least 1 form of highly effective contraception for...
- In the investigator's opinion, the participant (and the participant's legally acceptable representative, if applicable per local regulations or determination) is unwilling and/or unable to understand and fully comply...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Montgomery, Alabama, United States
- Surprise, Arizona, United States
- Fremont, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Jacksonville, Florida, United States
- Lauderdale Lakes, Florida, United States
- Melbourne, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Pembroke Pines, Florida, United States
- Riverview, Florida, United States
- Columbus, Georgia, United States
- East Point, Georgia, United States
- Boise, Idaho, United States
- Rockford, Illinois, United States
- Shreveport, Louisiana, United States
- Lansing, Michigan, United States
- Pontiac, Michigan, United States
+ 141 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Montgomery, Alabama, United States; Surprise, Arizona, United States; Fremont, California, United States; Los Angeles, California, United States; Orange, California, United States and 155 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.