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New treatment option for Microvascular Inflammation
Official title A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
ClinicalTrials.gov ID: NCT07219043
What this study is testing
What is Felzartamab?
Felzartamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for microvascular inflammation.
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
- In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
- 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 to 74
You may be able to join if
- MVI (MVI ≥2), donor specific antibody (DSA)-negative that is either complement activation (C4d) negative or C4d positive (biopsy-confirmed) without T...
- Biopsy must be within 3 months (preferably within 1 month) prior to randomization and meet adequate criteria (option a preferred over option b):
- Adequate: 10 or more non-sclerotic/evaluable glomeruli and two muscular arteries
- Minimally Adequate: at least 7 non-sclerotic/evaluable glomeruli and one muscular artery
- For participants who received any prior treatment for antibody-mediated rejection (AMR), MVI, or TCMR as outlined in Exclusion Criterion 5, the...
You likely can't join if
- Transplant: Blood type (ABO)-incompatible transplant.
- History of multiple organ transplants including en bloc and dual kidney transplants.
- Presence of HLA donor-specific antibodies.
- Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the next 30 days as determined by...
- Prior AMR or TCMR treatment (with the exception of corticosteroids) within 3 months prior to randomization is excluded as listed below. Participants...
- Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin [SCIg]) or plasma exchange (PLEX).
See the full eligibility criteria
- MVI (MVI ≥2), donor specific antibody (DSA)-negative that is either complement activation (C4d) negative or C4d positive (biopsy-confirmed) without T cell-mediated rejection (TCMR) per central reading, as defined by the...
- Biopsy must be within 3 months (preferably within 1 month) prior to randomization and meet adequate criteria (option a preferred over option b):
- Adequate: 10 or more non-sclerotic/evaluable glomeruli and two muscular arteries
- Minimally Adequate: at least 7 non-sclerotic/evaluable glomeruli and one muscular artery
- For participants who received any prior treatment for antibody-mediated rejection (AMR), MVI, or TCMR as outlined in Exclusion Criterion 5, the biopsy must be performed at least 6 weeks after completing (or stopping)...
- Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors).
- DSA: Human leukocyte antigen (HLA) Class I and II antigen-specific DSA-negative (preformed and de novo DSA) as determined by the local laboratory's definition of positivity using single-antigen bead-based assays within...
- Transplant: Blood type (ABO)-incompatible transplant.
- History of multiple organ transplants including en bloc and dual kidney transplants.
- Presence of HLA donor-specific antibodies.
- Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the next 30 days as determined by the Investigator.
- Prior AMR or TCMR treatment (with the exception of corticosteroids) within 3 months prior to randomization is excluded as listed below. Participants who received any of these treatments between 3 and 6 months prior to...
- Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin [SCIg]) or plasma exchange (PLEX).
- Complement system inhibitors (e.g., eculizumab).
- Proteasome inhibitors (e.g., bortezomib).
- The anti-interleukin-6 receptor (anti-IL-6R) tocilizumab.
- Any B cell-depleting therapy (including anti-CD20 agents [e.g., rituximab]) within 3 months prior to randomization.
- Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Kansas City, Kansas, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- West Orange, New Jersey, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Richmond, Virginia, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
- Buenos Aires, Ciudad Autónoma de Buenos Aires (caba), Argentina
+ 17 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 study runs about 1 year 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 to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States; Los Angeles, California, United States; Orange, California, United States; San Francisco, California, United States; Kansas City, Kansas, United States; Ann Arbor, Michigan, United States and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.