- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06685757
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) (TRANSCEND)
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)
In this study, researchers will learn more about the use of felzartamab in kidney transplant patients who have antibody-mediated rejection, also known as AMR. Kidney transplants can save lives for people with kidney failure. But even after a successful transplant, the body's immune system can sometimes attack the new kidney.
Antibody-mediated rejection (AMR) is when a person's immune system attacks a transplanted organ, like a new kidney. In the person receiving the transplant, their immune system creates specific antibodies. Antibodies are proteins that help the body fight infections. In people with AMR, these antibodies mistakenly see the new organ as a threat and damage its blood vessels. This can cause the new organ to fail.
In this study, researchers will learn more about how a study drug called felzartamab affects people with AMR. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce antibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works in participants with kidney transplants who experience AMR compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug. All participants in this study will have active AMR or AMR that has lasted for at least 6 months after their kidney transplant.
The main question that researchers want to answer is:
• How many participants have biopsy results showing that their transplanted kidney tissue looks normal or near normal after 24 weeks of treatment?
Researchers will also learn about:
- How long it takes before the participants' disease gets worse
- How long the participants' urine protein levels stay low
- Kidney biopsy scores to check for blood vessel inflammation at 6 months and 1 year
- How many people have no blood vessel inflammation at these times
- Changes in donor deoxyribonucleic acid (DNA) levels in blood from the start of treatment
- Biopsy test scores for signs of rejection and inflammation at 6 months and 1 year
- Changes in kidney function from the start of treatment
- How many people have biopsy results showing their kidney tissue looks normal again
- How long the transplanted kidney keeps working
- How many participants have medical problems during the study
- How many participants show signs of another type of kidney transplant rejection called T-cell-mediated rejection (TCMR) at Week 24 and Week 52
- How do results from vital signs, electrocardiograms (ECGs), and blood and urine tests change over time
- How felzartamab is processed by the body
- How many participants develop antibodies against felzartamab in the blood
The study will be done as follows:
- Participants will be screened to check if they can join the study. This will take up to 42 days.
- There will be 2 parts in this study.
- Part A of the study is "double blind." This means that neither the participants, study doctor, or site staff know if the participants received the study drug or a placebo. During Part A, participants will be randomized to receive up to 9 doses of either felzartamab or placebo.
- Part B of the study is "open label." This means that the participants, study doctor, and site staff know which study drug the participant is receiving. During Part B, all participants from Part A will receive up to 9 doses of felzartamab.
- All doses will be given through an "intravenous" infusion. This means it will be given into a vein. The dose the participants receive will depend on their body weight.
- Part A will last up to 24 weeks. Part B will last up to 28 weeks. In total, participants will have up to 21 study visits and will be in the study for about 1 year.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this study is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients diagnosed with active or chronic active AMR.
The secondary objectives of this study are: Part A: To evaluate the efficacy of felzartamab compared to placebo through additional clinical endpoints; Part B: To summarize felzartamab efficacy at Week 52 in kidney transplant recipients diagnosed with active or chronic active AMR; Parts A and B: To evaluate the safety of felzartamab in kidney transplant recipients diagnosed with active or chronic AMR and to assess the pharmacokinetic (PK) profile and immunogenicity of felzartamab.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Global Biogen Clinical Trial Center
- Email: clinicaltrials@biogen.com
Study Contact Backup
- Name: US Biogen Clinical Trial Center
- Phone Number: 1-866-633-4636
- Email: clinicaltrials@biogen.com
Study Locations
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Córdoba, Argentina, X5000
- Recruiting
- Clínica Privada Vélez Sarsfield
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Principal Investigator:
- Rafael Maldonado
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Contact:
- Phone Number: 54 9351 8092559
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Autónoma de Buenos Aires
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Cdad, Autónoma de Buenos Aires, Argentina, C1425 C1425EGH
- Recruiting
- Instituto de Trasplante y Alta Complejidad (ITAC)
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Contact:
- Phone Number: 54 91158102922
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Principal Investigator:
- Maria del Carmen Rial
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Woolloongabba, Australia, QLD 4102
- Recruiting
- Princess Alexandra Hospital
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Australia
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Parkville VIC, Australia, Australia, 3050
- Recruiting
- Royal Melbourne Hospital
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New South Wales
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Sydney, New South Wales, Australia, 2145
- Recruiting
- Westmead Hospital
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- Recruiting
- Fiona Stanley Hospital
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Vienna
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Spitalgasse, Vienna, Austria, 1090
- Recruiting
- Medical University of Vienna
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Contact:
- Phone Number: +43 (0)1 40400-43630
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Principal Investigator:
- George A. Bohmig
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Porto Alegre - RS
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Centro Histórico, Porto Alegre - RS, Brazil, 90020-090
- Recruiting
- Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer
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Contact:
- Phone Number: 55 51 3214 8640
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Principal Investigator:
- Valter Duro Garcia
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São José Do Rio Preto
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Vila São José, São José Do Rio Preto, Brazil, 15090-000
- Recruiting
- Hospital de Base da Faculdade de Medicina de São José do Rio Preto
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Contact:
- Phone Number: 5656 55 17 3201-5000
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Principal Investigator:
- Mário Filho Abbed
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São Paulo
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Cerqueira César, São Paulo, Brazil, 05403-010
- Recruiting
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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Contact:
- Phone Number: 55 11 2661 8089
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Principal Investigator:
- Elias David Neto
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Vila Clementino, São Paulo, Brazil, 04038-002
- Recruiting
- Fundação Oswaldo Ramos - Hospital do Rim (HRIM)
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Contact:
- Phone Number: +55 11 5087 8113
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Principal Investigator:
- Silva Helio Tedesco
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Alberta
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Edmonton, Alberta, Canada, T6G 2C8
- Recruiting
- University of Alberta
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Principal Investigator:
- Sita Gourishankar
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Contact:
- Phone Number: 587-598-2336
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Recruiting
- Vancouver General Hospital
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Contact:
- Phone Number: 604-875-5950
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Principal Investigator:
- James Lan
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Vancouver, British Columbia, Canada, V6T 1Z3
- Recruiting
- The University of British Columbia (UBC)/St. Paul's Hospital part of Providence Health Care
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Contact:
- Phone Number: 604-682-2344
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Principal Investigator:
- Gill John
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Quebec
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Montreal, Quebec, Canada, H3G 1A4
- Recruiting
- McGill University
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Contact:
- Phone Number: 514- 934-1934
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Principal Investigator:
- Marclo Cantarovich
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-
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Praha 4
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Czechia, Praha 4, Czechia, 14021
- Recruiting
- Institute for Clinical and Experimental Medicine (IKEM)
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Principal Investigator:
- Ondrej Viklicky
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Contact:
- Phone Number: 0042 0261364110
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Bordeaux, France, 32000
- Recruiting
- CHU Lyon Hôpital Edouard Herriot
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Principal Investigator:
- Lionel Couzi
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Contact:
- Phone Number: 33 5 56 79 55 38
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La Tronche, France, 38700
- Recruiting
- CHU Grenoble Alpes Hôpital Michallon
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Principal Investigator:
- Lionel Rostaing
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Contact:
- Phone Number: 0033 5 56 79 55 38
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Lyon, France, 69003
- Recruiting
- Hospices Civils de lyon - Hôpital Edouard Herriot
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Principal Investigator:
- Olivier Thaunat
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Contact:
- Phone Number: 334 2785 8000
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Toulouse, France, 31400
- Recruiting
- Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil
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Principal Investigator:
- Nassim Kamar
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Contact:
- Phone Number: 33 5 61 32 32 00
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Berlin, Germany, 10117
- Recruiting
- Charité university
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Principal Investigator:
- Klemens Budde
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Contact:
- Phone Number: 4930450514002
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Dresden, Germany, 1307
- Recruiting
- Universitaetsklinikum Carl Gustav Carus Dresden
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Principal Investigator:
- Christian Hugo
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Contact:
- Phone Number: 0049 351 458 4233
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Hamburg, Germany, 20246
- Recruiting
- Universitätsklinikum Hamburg-Eppendorf
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Contact:
- Phone Number: +49 (0)40 7410-52240
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Principal Investigator:
- Florian Grahammer
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Regensburg, Germany, 93053
- Recruiting
- Universitätsklinikum Regensburg
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Contact:
- Phone Number: 499419447301
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Principal Investigator:
- Barnhard Banas
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Auckland
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Grafton, Auckland, New Zealand, 1023
- Recruiting
- Auckland City Hospital
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-
-
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Zaragoza, Spain, 50009
- Recruiting
- Hospital Universitario Miguel Servet
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Contact:
- Phone Number: 0034 976 765 624
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Principal Investigator:
- Alex Dalmau
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Barcelona
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Calle Villarroel, Barcelona, Spain, 8036
- Recruiting
- Hospital Clínic de Barcelona
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Principal Investigator:
- Fritz Diekmann
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Contact:
- Phone Number: 34 93 227 5444
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Ciutat Vella, Barcelona, Spain, 8003
- Recruiting
- Hospital del Mar
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Contact:
- Phone Number: 0034 93 248 31 62
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Principal Investigator:
- Marta Barrio Crespo
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Horta-Guinardó, Barcelona, Spain, 8035
- Recruiting
- Hospital Universitario Vall d'Hebron
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Contact:
- Phone Number: 34934893000
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Principal Investigator:
- Oriol Bestard Matamoros
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L'Hospitalet de Llobregat, Barcelona, Spain, 8907
- Recruiting
- Hospital Universitario de Bellvitge
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Contact:
- Phone Number: 0034 93 260 73 85
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Principal Investigator:
- Eduardo Melilli
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-
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-
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Zurich, Switzerland, 8091
- Recruiting
- Universitätsspital Zürich
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Contact:
- Phone Number: 41 44 255 33 84
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Principal Investigator:
- Thomas Schachtner
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Basel
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Petersgraben, Basel, Switzerland, 4031
- Recruiting
- University Hospital Basel
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Contact:
- Phone Number: 0041 61 265 44 07
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Principal Investigator:
- Matthais Diebold
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-
-
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California
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Los Angeles, California, United States, 90048
- Recruiting
- Cedars-Sinai Medical Center
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Principal Investigator:
- Edmund Huang
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Contact:
- Phone Number: 310-423-3069
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Los Angeles, California, United States, 90033
- Recruiting
- University of Southern California
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Contact:
- Phone Number: 800-872-2273
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Principal Investigator:
- Maw Thin Thin
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Los Angeles, California, United States, 90095
- Recruiting
- UCLA
-
Principal Investigator:
- Suphamai Bunnapradist
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Contact:
- Phone Number: 310-794-8516
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Orange, California, United States, 92868
- Recruiting
- Providence Healthcare
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Contact:
- Phone Number: 714-771-8000
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Principal Investigator:
- Yasir Qazi
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San Bernardino, California, United States, 92408
- Recruiting
- Loma Linda
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Principal Investigator:
- Rafael Villicana
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Contact:
- Phone Number: 909-558-3636
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San Francisco, California, United States, 94143
- Recruiting
- University of California, San Francisco
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Contact:
- Phone Number: 415-353-1551
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Principal Investigator:
- Puneet Sood
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San Francisco, California, United States, 94109
- Recruiting
- California Pacific Medical Center
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Contact:
- Phone Number: 415-600-1070
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Principal Investigator:
- Ram V. Peddi
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Colorado
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Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado
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Contact:
- Phone Number: 303-724-483
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Principal Investigator:
- James Cooper
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Illinois
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Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago
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Contact:
- Phone Number: 773-702-0316
-
Principal Investigator:
- Beatrice Concepcion
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Kansas
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Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas
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Principal Investigator:
- Diane Cibrik
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Contact:
- Phone Number: 913-588-8239
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Recruiting
- Tulane University Health Sciences Center
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Contact:
- Phone Number: 504-503-7021
-
Principal Investigator:
- Diala Khirfan
-
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
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Principal Investigator:
- Mona Doshi
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Contact:
- Phone Number: 734-763-1407
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
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Contact:
- Phone Number: 507-293-2643
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Principal Investigator:
- Carrie Schinstock
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Missouri
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St Louis, Missouri, United States, 63130
- Recruiting
- Washington University
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Contact:
- Phone Number: 314-362-4109
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Principal Investigator:
- Tarek Alhamand
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Nebraska
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Omaha, Nebraska, United States, 68198-5331
- Recruiting
- University of Nebraska
-
Contact:
- Phone Number: 402-559-9315
-
Principal Investigator:
- Mannon Langewisch
-
-
New Jersey
-
West Orange, New Jersey, United States, 07039
- Recruiting
- Cooperman Barnabas Medical Center
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Principal Investigator:
- Anup Patel
-
Contact:
- Phone Number: 973-322-2146
-
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North Carolina
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Durham, North Carolina, United States, 27705
- Recruiting
- Duke University
-
Contact:
- Phone Number: 919-613-6133
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Principal Investigator:
- Scott Sanoff
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-
Ohio
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Cincinnati, Ohio, United States, 45219
- Recruiting
- University of Cincinnati
-
Contact:
- Phone Number: 513-558-6709
-
Principal Investigator:
- Steve Woodle
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Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic
-
Principal Investigator:
- Emilio Poggio
-
Contact:
- Phone Number: 216-444-5383
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Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University
-
Principal Investigator:
- Todd Pesavento
-
Contact:
- Phone Number: 614-293-6883
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Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Penn Medicine - Hospital of the University of Pennsylvania
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Principal Investigator:
- Roy Bloom
-
Contact:
- Phone Number: 215-662-4643
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Tennessee
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University
-
Contact:
- Phone Number: 615-936-1179
-
Principal Investigator:
- Anthony Langone
-
-
Texas
-
Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern Medical Center
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Principal Investigator:
- David Wojciechowski
-
Contact:
- Phone Number: 214-645-0444
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Houston, Texas, United States, 77030
- Recruiting
- Houston Methodist
-
Contact:
- Phone Number: 713-441-6222
-
Principal Investigator:
- Osama Gaber
-
-
Virginia
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Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University
-
Principal Investigator:
- Gaurav Gupta
-
Contact:
- Phone Number: 804-828-1855
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-
Washington
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Seattle, Washington, United States, 98195
- Recruiting
- University of Washington Medical Center
-
Contact:
- Phone Number: 206-598-5896
-
Principal Investigator:
- Nicole Leca
-
-
Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Medical College of Wisconsin
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Contact:
- Phone Number: 414-805-6060
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Principal Investigator:
- Matt Cooper
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
- 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 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:
- Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin [SCIg]) or PLEX.
- Complement system inhibitors (e.g., eculizumab).
- Proteasome inhibitors (e.g., bortezomib).
- Tocilizumab.
- Any B cell-depleting therapy (including anti-Cluster of Differentiation 20 [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 apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
Participants will receive 0.9% saline solution by intravenous infusion.
|
|
Experimental: Felzartamab
|
Participants will receive felzartamab by intravenous infusion.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR)
Time Frame: Week 24
|
Week 24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Part A: Microvascular Inflammation (MVI) Score
Time Frame: Week 24
|
Week 24
|
|
Part A: Percentage of Participants Who Achieve an MVI Score of 0
Time Frame: Week 24
|
Week 24
|
|
Part A: Change from Baseline in Donor-derived Cell-free DNA (dd-cfDNA)
Time Frame: Baseline, Week 24
|
Baseline, Week 24
|
|
Part A: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline, Week 24
|
Baseline, Week 24
|
|
Part B: Percentage of Participants Who Achieve BPHR
Time Frame: Weeks 24 and 52
|
Weeks 24 and 52
|
|
Part B: MVI Score
Time Frame: Weeks 24 and 52
|
Weeks 24 and 52
|
|
Part B: Percentage of Participants Who Achieve an MVI Score of 0
Time Frame: Weeks 24 and 52
|
Weeks 24 and 52
|
|
Part B: Change from Baseline in dd-cfDNA
Time Frame: Baseline, Weeks 24 and 52
|
Baseline, Weeks 24 and 52
|
|
Part B: Change from Baseline in eGFR
Time Frame: Baseline, Weeks 24 and 52
|
Baseline, Weeks 24 and 52
|
|
Part B: Time to All-cause Allograft Loss
Time Frame: Up to Week 52
|
Up to Week 52
|
|
Parts A and B: Number of Participants with Adverse Events
Time Frame: From time of first dose to end of trial visit (Up to Week 52)
|
From time of first dose to end of trial visit (Up to Week 52)
|
|
Parts A and B: Number of Participants with Clinically Significant Laboratory Abnormalities
Time Frame: From time of first dose to end of trial visit (Up to Week 52)
|
From time of first dose to end of trial visit (Up to Week 52)
|
|
Parts A and B: Number of Participants with Clinically Significant Vital Signs Abnormalities
Time Frame: From time of first dose to end of trial visit (Up to Week 52)
|
From time of first dose to end of trial visit (Up to Week 52)
|
|
Parts A and B: Number of Participants with Clinically Significant ECG Abnormalities
Time Frame: From time of first dose to end of trial visit (Up to Week 52)
|
From time of first dose to end of trial visit (Up to Week 52)
|
|
Parts A and B: Percentage of Participants with T Cell-mediated Rejection (TCMR) by Biopsy
Time Frame: Weeks 24 and 52
|
Weeks 24 and 52
|
|
Parts A and B: Felzartamab Serum Concentration
Time Frame: Up to Week 52
|
Up to Week 52
|
|
Parts A and B: Number of Participants with Anti-drug Antibodies (ADAs) against Felzartamab
Time Frame: Baseline, up to Week 52
|
Baseline, up to Week 52
|
|
Part A: Biopsy-based Transcript Composite Score for AMR/MVI
Time Frame: At Week 24
|
At Week 24
|
|
Part B: Biopsy-based Transcript Composite Score for AMR/MVI
Time Frame: At Week 52
|
At Week 52
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 299AR301
- 2024-519095-66-00 (Ctis)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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HI-Bio, A Biogen CompanyCompletedTrial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) (M-PLACE)Glomerulonephritis, Membranous | antiPLA2R PositiveSpain, Belgium, Australia, Italy, United States, Korea, Republic of, France, Netherlands, Poland
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Farsad EskandaryCharite University, Berlin, Germany; University of Alberta; HI-BioCompleted