Felzartamab for Microvascular Inflammation
(TRANSPIRE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how effectively the drug felzartamab reduces microvascular inflammation (MVI), a condition where small blood vessels in a transplanted kidney become inflamed, potentially indicating rejection. The main goal is to determine if felzartamab can halt active kidney inflammation after 24 weeks of treatment. Initially, participants will receive either felzartamab or a placebo; in the second phase, all participants will receive the drug. Ideal candidates for this trial are those who had a kidney transplant over six months ago and have biopsy-confirmed MVI without signs of certain types of rejection. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have received certain treatments for kidney rejection recently, you may need to wait before joining the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that felzartamab is likely to be safe for humans?
Research has shown that felzartamab is generally safe for individuals who have undergone a kidney transplant. Studies have found that patients can receive it without major issues. In a previous study, researchers assessed the safety of felzartamab and found that most participants tolerated it well, with few experiencing severe side effects.
Researchers closely monitored any unwanted health issues, and while some were reported, they were uncommon. This indicates that while side effects may occur, they are usually not serious and do not affect most individuals taking the drug.
Overall, felzartamab appears to be a promising and safe option for treating inflammation in transplanted kidneys.12345Why do researchers think this study treatment might be promising?
Felzartamab is unique because it targets microvascular inflammation directly, which is a new approach compared to traditional treatments that often focus on broader anti-inflammatory strategies. This specificity means it could potentially offer more targeted relief with fewer side effects. Researchers are excited because felzartamab is administered via multiple IV doses, allowing for controlled dosing and potentially faster action in reducing inflammation. Additionally, the placebo-controlled arm of the trial helps to ensure the treatment's effectiveness is clearly demonstrated, which is promising for future applications.
What evidence suggests that felzartamab might be an effective treatment for microvascular inflammation?
Research has shown that felzartamab can reduce inflammation in the small blood vessels of kidney transplant patients. One study found that patients taking felzartamab had a much lower average inflammation score compared to those taking a placebo (0 vs. 2.5). In this trial, participants will receive either multiple IV doses of felzartamab or a combination of placebo followed by felzartamab. This suggests that felzartamab might effectively address the small blood vessel damage associated with transplant rejection. Additionally, felzartamab has shown potential in managing antibody-mediated rejection, a major challenge in kidney transplants. These findings suggest that felzartamab could help manage kidney inflammation and improve transplant success.14567
Who Is on the Research Team?
Medical Director
Principal Investigator
Biogen
Are You a Good Fit for This Trial?
Adults with a kidney transplant who later developed microvascular inflammation (MVI) without signs of T cell-mediated rejection. They must have had their transplant at least 6 months ago and be negative for certain antibodies. A recent biopsy confirming MVI is required, and they should not have received specific prior treatments for related conditions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants receive either felzartamab or placebo for 24 weeks. Neither the researchers nor the participants will know who is receiving felzartamab or placebo.
Treatment Part B
All participants receive felzartamab for an additional 28 weeks. Both participants and researchers will know this.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including kidney biopsies and lab tests.
What Are the Treatments Tested in This Trial?
Interventions
- Felzartamab
Trial Overview
The study tests felzartamab's effects on kidney inflammation in two parts: first, participants are randomly given either felzartamab or a placebo without knowing which one; then all receive felzartamab openly. The main focus is to see if the drug reduces signs of inflammation after 24 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive multiple IV doses of felzartamab.
Participants will receive multiple IV doses of placebo followed by multiple doses of IV felzartamab.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biogen
Lead Sponsor
Daniel Quirk
Biogen
Chief Medical Officer
MD
Christopher A. Viehbacher
Biogen
Chief Executive Officer since 2022
Graduated from Queen's University, Kingston, Ontario, Canada
Citations
A Randomized Phase 2 Trial of Felzartamab in Antibody- ...
The median microvascular inflammation score was lower in the felzartamab group than in the placebo group (0 vs. 2.5), for a mean difference ...
A Randomized Phase 2 Trial of Felzartamab in Antibody- ...
The median microvascular inflammation score was lower in the felzartamab group than in the placebo group (0 vs. 2.5), for a mean difference ...
3.
investors.biogen.com
investors.biogen.com/news-releases/news-release-details/biogen-highlights-potential-felzartamab-range-immune-mediatedBiogen Highlights the Potential of Felzartamab for a Range ...
This Phase 3 study (NCT06685757) will evaluate the efficacy and safety of felzartamab compared to placebo in adult kidney transplant recipients ...
Effect of felzartamab on the molecular phenotype ...
A recent randomized controlled trial demonstrated that treatment with anti-CD38 monoclonal antibody felzartamab suppressed antibody-mediated rejection (ABMR) ...
Study Details | NCT06685757 | A Trial of Felzartamab in ...
The main goal of this trial is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients diagnosed with late active or chronic ...
Playing It Safe: Can Felzartamab Fill the Gap in AMR ...
The current phase 2 trial suggests that felzartamab is safe to be administered in patients with kidney transplant and AMR.
7.
investors.biogen.com
investors.biogen.com/news-releases/news-release-details/biogen-initiates-phase-3-study-felzartamab-treatment-lateBiogen Initiates Phase 3 Study of Felzartamab for the ...
The Phase 3 study will evaluate the efficacy and safety of the investigational drug felzartamab compared to placebo in adult kidney transplant recipients.
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