Immunoglobulin A Nephropathy study: Felzartamab
Official title A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)
ClinicalTrials.gov ID: NCT06935357
What this study is testing
What is Felzartamab?
This is an investigational medicine being studied as a potential treatment for IgA nephropathy, a kidney disease. It is designed to target certain immune cells that produce abnormal antibodies.
Also referred to as MOR202, MOR03087, TJ202, HIB202, BIIB148.
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
- The main goal is to see how much protein in the urine changes after 36 weeks. Researchers also want to learn if the drug helps the kidneys filter blood better and if it is safe.
- Who it's for
- The study is looking for adults who have IgAN, a kidney disease caused by antibody buildup, and have protein in their urine.
- What's involved
- Participants will get a drug or a fake shot (placebo) through an IV (tube in the vein). No one will know which one they get. They will also have regular check-ups and tests.
- Time commitment
- The study lasts about 2 years and includes 17 visits to the clinic.
- Phase 3: a large, late-stage study
- Time commitment: about 2 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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
- Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF).
- An eGFR ≥ 30 mL/min/1.73 m\^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula.
- Proteinuria of ≥ 1.0 gram per day (g/day) or UPCR ≥0.8 gram per gram (g/g) as assessed by an adequate 24-hour urine collection.
- Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor...
You likely can't join if
- Any history of secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits as determined by...
- History of rapidly progressive variant of IgAN, defined as eGFR loss by \> 50% per 3 months and not explained by changes in renin-angiotensin system...
- IgAN-(MCD) variant.
- Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.
- Type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) \> 8% at Screening, or evidence of diabetic nephropathy on biopsy, history of diabetic...
- Any diagnosed or suspected immunosuppressed or immunodeficient state such as asplenia, human immunodeficiency virus (HIV), primary...
See the full eligibility criteria
- Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF).
- An eGFR ≥ 30 mL/min/1.73 m\^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of ≥ 20 and \< 30 mL/min/1.73 m\^2 is acceptable for the cohorts 3 and 4.
- Proteinuria of ≥ 1.0 gram per day (g/day) or UPCR ≥0.8 gram per gram (g/g) as assessed by an adequate 24-hour urine collection.
- Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks prior to Screening.
- Any history of secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits as determined by the Investigator.
- History of rapidly progressive variant of IgAN, defined as eGFR loss by \> 50% per 3 months and not explained by changes in renin-angiotensin system (RAS) blockade or other factors.
- IgAN-(MCD) variant.
- Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.
- Type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) \> 8% at Screening, or evidence of diabetic nephropathy on biopsy, history of diabetic microvascular or macrovascular disease (eg, diabetic retinopathy, peripheral...
- Any diagnosed or suspected immunosuppressed or immunodeficient state such as asplenia, human immunodeficiency virus (HIV), primary immunodeficiencies, organ or bone marrow transplantation, with the exception of corneal...
- Previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium...
- Participants currently treated with oral budesonide. Participants who have stopped this therapy ≥ 4 months prior to Screening may be eligible.
- Active clinically significant infections, known history of recurrent clinically significant infection, or Screening laboratory evidence consistent with an active infection, or non-prophylactic treatment with IV...
- Hypogammaglobulinemia: serum Immunoglobin G (IgG) \< 6.0 gram per litre (g/L), at Screening. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Little Rock, Arkansas, United States
- Apple Valley, California, United States
- Carlsbad, California, United States
- Los Angeles, California, United States
- Oxnard, California, United States
- San Dimas, California, United States
- Bradenton, Florida, United States
- Gainesville, Florida, United States
- Hollywood, Florida, United States
- Orlando, Florida, United States
- Port Saint Lucie, Florida, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Detroit, Michigan, United States
- Brookhaven, Mississippi, United States
- New York, New York, United States
- The Bronx, New York, United States
- Providence, Rhode Island, United States
- Knoxville, Tennessee, United States
- Dallas, Texas, United States
+ 199 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, but confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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?
This study is enrolling now at Little Rock, Arkansas, United States; Apple Valley, California, United States; Carlsbad, California, United States; Los Angeles, California, United States; Oxnard, California, United States; San Dimas, California, United States and 213 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.