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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06685757




Registration number
NCT06685757
Ethics application status
Date submitted
11/11/2024
Date registered
12/11/2024
Date last updated
10/09/2025

Titles & IDs
Public title
A Trial of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)
Scientific title
A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)
Secondary ID [1] 0 0
2024-519095-66-00
Secondary ID [2] 0 0
299AR301
Universal Trial Number (UTN)
Trial acronym
TRANSCEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antibody-mediated Rejection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Felzartamab
Treatment: Drugs - Placebo

Experimental: Felzartamab -

Placebo comparator: Placebo -


Treatment: Drugs: Felzartamab
Participants will receive felzartamab by intravenous infusion.

Treatment: Drugs: Placebo
Participants will receive 0.9% saline solution by intravenous infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR)
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Part A: Microvascular Inflammation (MVI) Score
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Part A: Percentage of Participants Who Achieve an MVI Score of 0
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Part A: Change from Baseline in Donor-derived Cell-free DNA (dd-cfDNA)
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Part A: Change from Baseline in Biopsy-based Transcript Composite Score for AMR/MVI
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Part A: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Timepoint [5] 0 0
Baseline, Week 24
Secondary outcome [6] 0 0
Part B: Percentage of Participants Who Achieve BPHR
Timepoint [6] 0 0
Weeks 24 and 52
Secondary outcome [7] 0 0
Part B: MVI Score
Timepoint [7] 0 0
Weeks 24 and 52
Secondary outcome [8] 0 0
Part B: Percentage of Participants Who Achieve an MVI Score of 0
Timepoint [8] 0 0
Weeks 24 and 52
Secondary outcome [9] 0 0
Part B: Change from Baseline in dd-cfDNA
Timepoint [9] 0 0
Baseline, Weeks 24 and 52
Secondary outcome [10] 0 0
Part B: Change from Baseline in Biopsy-based Transcript Composite Score for AMR/MVI
Timepoint [10] 0 0
Baseline, Weeks 24 and 52
Secondary outcome [11] 0 0
Part B: Change from Baseline in eGFR
Timepoint [11] 0 0
Baseline, Weeks 24 and 52
Secondary outcome [12] 0 0
Part B: Time to All-cause Allograft Loss
Timepoint [12] 0 0
Up to Week 52
Secondary outcome [13] 0 0
Parts A and B: Number of Participants with Adverse Events
Timepoint [13] 0 0
From time of first dose to end of trial visit (Up to Week 52)
Secondary outcome [14] 0 0
Parts A and B: Number of Participants with Clinically Significant Laboratory Abnormalities
Timepoint [14] 0 0
From time of first dose to end of trial visit (Up to Week 52)
Secondary outcome [15] 0 0
Parts A and B: Number of Participants with Clinically Significant Vital Signs Abnormalities
Timepoint [15] 0 0
From time of first dose to end of trial visit (Up to Week 52)
Secondary outcome [16] 0 0
Parts A and B: Number of Participants with Clinically Significant ECG Abnormalities
Timepoint [16] 0 0
From time of first dose to end of trial visit (Up to Week 52)
Secondary outcome [17] 0 0
Parts A and B: Percentage of Participants with T Cell-mediated Rejection (TCMR) by Biopsy
Timepoint [17] 0 0
Weeks 24 and 52
Secondary outcome [18] 0 0
Parts A and B: Felzartamab Serum Concentration
Timepoint [18] 0 0
Up to Week 52
Secondary outcome [19] 0 0
Parts A and B: Number of Participants with Anti-drug Antibodies (ADAs) against Felzartamab
Timepoint [19] 0 0
Baseline, up to Week 52

Eligibility
Key inclusion criteria
Key

* Active or chronic active AMR (biopsy-confirmed) without TCMR per central reading, as defined by the Banff 2022 criteria.
* Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors).
* Donor-specific antibody (DSA): Human leukocyte antigen (HLA) Class I and/or II antigen-specific DSA-positive (preformed and/or de novo DSA) as determined by the local laboratory's definition of positivity using singleantigen bead-based assays within 3 months prior to randomization.

Key
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Transplant: Blood type (ABO)-incompatible transplant.
* History of multiple organ transplants including en bloc and dual kidney transplants.
* Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the subsequent 30 days as determined by the Investigator.
* Treatment: Prior AMR/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 randomization must have both a renal biopsy (IC3) and DSA testing at least 6 weeks after completing (or stopping) treatment in order to confirm continuing AMR and to determine eligibility:

1. Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin [SCIg]) or PLEX.
2. Complement system inhibitors (e.g., eculizumab).
3. Proteasome inhibitors (e.g., bortezomib).
4. Tocilizumab. e. Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization.

Other protocol-defined inclusion/exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Austria
State/province [18] 0 0
Vienna
Country [19] 0 0
Brazil
State/province [19] 0 0
São Paulo
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
New Zealand
State/province [25] 0 0
Auckland
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Switzerland
State/province [27] 0 0
Basel

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US Biogen Clinical Trial Center
Address 0 0
Country 0 0
Phone 0 0
1-866-633-4636
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06685757