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Enrolling by invitationNCT07444489Updated Nov 2, 2026

A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE)

A Phase 3 interventional study of Felzartamab in Antibody-mediated Rejection and Microvascular Inflammation, sponsored by Biogen. Enrolling by invitation at 15 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Biogen · Phase 3, Interventional, and Treatment

Updated Nov 2, 2026First site in CanadaPrimary completion moved+3 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
201
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and then developed antibody-mediated rejection (AMR) or microvascular inflammation (MVI). AMR happens when the body's immune system creates donor-specific antibodies (DSAs) that attack the transplanted kidney. In late AMR, this typically happens more than 6 months after the kidney transplant. MVI is a condition where the small blood vessels in the transplanted kidney become inflamed. MVI can happen with or without DSAs. Both AMR and MVI can cause the transplanted kidney to stop working properly.

Two earlier studies looked at felzartamab in kidney transplant recipients. Study 299AR301 (TRANSCEND) (NCT06685757) included participants with AMR. Study 299AR201 (TRANSPIRE) (NCT07219043) included participants with MVI.

This study, 299AR302-299AR301 LTE, is a long-term extension of both of these "parent" studies. Participants who join this study will have the opportunity to receive felzartamab for up to 4 more years after completing their parent study.

The goal of this study is to learn more about the long-term safety and effects of felzartamab in people with kidney transplants. This study is part of a group of studies looking at long-term felzartamab use in people with organ transplants. This study is a substudy of the main study 299AR302.

The main question researchers will answer relate to safety. Namely, how many participants have adverse events during the study and how lab test results change over time. Adverse events are health problems that may or may not be caused by the study drug.

Researchers will perform kidney biopsies to track kidney health. Researchers will also study how felzartamab affects kidney inflammation, kidney function, immune activity, and overall health.

The study will be done as follows:

  • Participants who complete the final visit of the treatment period in one of the parent studies can enroll in this study. This includes participants who stopped receiving felzartamab early but still attended their final visits.
  • Participants who did not stop receiving felzartamab in their parent study will continue to receive felzartamab for up to 4 more years in this study. Participants may also stop felzartamab during this study at any time.
  • Participants who stopped receiving felzartamab in their parent study will only attend study visits for health monitoring- they will not receive felzartamab.
  • Felzartamab will be given as an intravenous (IV) infusion, which is a slow injection into a vein using a needle.
  • Participants receiving felzartamab may have up to 27 study visits over 200 weeks with an additional safety follow-up visit after their final dose.
  • Participants who are not receiving felzartamab may have up to 9 study visits over 200 weeks.
Read the detailed description

The primary objective of this study is to evaluate the long-term safety of felzartamab. The secondary objectives of this study are to describe the ongoing efficacy of felzartamab on biopsy-proven histologic response (BPHR), microvascular inflammation (MVI) and graft function; and to evaluate pharmacokinetics (PK) and immunogenicity of felzartamab.

02

Conditions studied

  • Antibody-mediated Rejection
  • Microvascular Inflammation

Keywords

  • AMR, Felzartamab, Kidney Transplant
  • Kidney Transplant Rejection
03

In context

Lead sponsor

Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 50 (50%) have results posted.

Browse Biogen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Have completed the parent study Week 52 visit or will be completing Week 52 visit procedures (for participants who sign consent before reaching the Week 52 visit).

  • Have received at least one dose of felzartamab in the parent studies, and had the following disposition status in the parent study:

    • Ongoing Treatment: Did not discontinue felzartamab treatment in the parent study and received a dose at the Week 44 visit.
    • Treatment Interrupted: Did not discontinue felzartamab treatment in the parent study and did not receive a dose at the Week 44 visit.
    • Off Treatment, On Study: Discontinued felzartamab treatment in the parent study and were not withdrawn from the study.

Participants who discontinued study treatment prior to receiving any doses of felzartamab in the parent study (i.e., those in the placebo group who discontinued before receiving felzartamab) are not eligible for enrollment in this substudy.

  • For participants enrolling into this study who have not discontinued felzartamab treatment in the parent study only: The Investigator has determined that the participant could benefit from continued felzartamab treatment.

Key Exclusion Criteria:

  • Met a treatment discontinuation criterion in the parent study but treatment was not discontinued (for example, because the criterion was met after the last dose of felzartamab in the parent study).

Note: Other protocol-defined inclusion/exclusion criteria apply.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
201 participants (estimated)

Study arms

  • Experimental
    Felzartamab: Long-Term Extension Treatment

    Participants will receive multiple IV doses of felzartamab.

    Drug: Felzartamab

  • Experimental
    Felzartamab: Off-Treatment Observation

    Participants who were off treatment but still continued participating in the respective parent study at the time of enrollment into the LTE or who have discontinued felzatamab treatment after receiving one or more doses in this substudy will be encouraged to continue being followed off-treatment.

    Drug: Felzartamab

Interventions

  • DrugFelzartamab

    Administered IV

    Also known as: MOR202, MOR03087, TJ202, HIB202, BIIB148

06

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)

    Time frame: From first dose of study drug up to end of study follow-up (Up to Week 204)

  2. Number of Participants who Discontinue Treatment due to an AE

    Time frame: From first dose of study drug up to end of study follow-up (Up to Week 204)

  3. Number of Participants with Clinically Significant Laboratory, Vital Signs and Electrocardiograms (ECGs) Abnormalities

    Time frame: From first dose of study drug up to end of trial visit (up to Week 200)

Secondary outcomes

  1. Percentage of Participants Achieving Biopsy-proven Histologic Resolution (BPHR)

    Time frame: Up to Week 200

  2. Microvascular Inflammation (MVI) Score

    Time frame: Up to Week 200

  3. Percentage of Participants Achieving an MVI Score of 0 by Each Biopsy Timepoint

    Time frame: Up to Week 200

  4. Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Baseline, Week 200

  5. Change From Baseline in Proteinuria

    Time frame: Baseline, Week 200

  6. Time to All-cause Allograft Loss

    Time frame: Up to Week 200

  7. Time to Death Censored Allograft Loss

    Time frame: Up to Week 204

  8. Felzartamab Serum Concentration

    Time frame: At Week 200

  9. Number of Participants with Anti-drug Antibodies (ADAs) Against Felzartamab

    Time frame: At Week 200

07

Study locations

15 sites
08

References and documents

Individual participant data

Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Apr 2026 (actual). Primary completion is estimated for Dec 2031, 68 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: primary completion May 2031 → Dec 2031 and completion May 2031 → Dec 2031.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2026
First posted
Mar 3, 2026
StartActual
Apr 16, 2026
Primary completionEst.
Dec 31, 2031was May 2031
CompletionEst.
Dec 31, 2031was May 2031
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added — first site in Canada
Show 2 added (1 United States, 1 Canada)
  • Cedars-Sinai Medical Center · Los Angeles, United States
  • Providence Health Care - St. Paul's Hospital · Vancouver, Canada
across 2 updates, Oct 9, 2026 – Nov 2, 2026
Primary completion
May 28, 2031→Dec 31, 2031
Sep 30, 2026
Study completion
May 28, 2031→Dec 31, 2031
Sep 30, 2026
Interventions
Arm changed Long-Term Extension: Felzartamab→Felzartamab: Long-Term Extension Treatment. Arms added: Felzartamab: Off-Treatment Observation
Sep 30, 2026
Show all 3 updates
  1. Nov 2, 2026
    1 site added — first site in Canada
    Show site
    • Providence Health Care - St. Paul's Hospital · Vancouver, Canada
  2. Oct 9, 2026
    1 site added
    Show site
    • Cedars-Sinai Medical Center · Los Angeles, United States
    + 1 other change: verification date
  3. Sep 30, 2026
    Primary completion May 28, 2031→Dec 31, 2031
    Study completion May 28, 2031→Dec 31, 2031
    Interventions Arm changed Long-Term Extension: Felzartamab→Felzartamab: Long-Term Extension Treatment. Arms added: Felzartamab: Off-Treatment Observation
    + 1 other change: design details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07444489
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Mar 3, 2026
Start date
Apr 16, 2026
Primary completion
Dec 31, 2031 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Nov 2, 2026

Study contacts

Medical Director
study director · Biogen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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