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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003682-34 | EudraCT Number | ||
| VKTX01 | Other Identifier | Vitaeris |
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Early stop for lack of efficacy/futility (at Interim analysis)
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| Name | Class |
|---|---|
| ICON Clinical Research | INDUSTRY |
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This trial investigates the efficacy and safety of clazakizumab [an anti-interleukin (IL)-6 monoclonal antibody (mAb)] for the treatment of CABMR in recipients of a kidney transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clazakizumab | Active Comparator | Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6 that is administered subcutaneously. |
|
| Placebo | Placebo Comparator | Physiologic saline solution that is administered subcutaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clazakizumab | Biological | Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 52 in Estimated Glomerular Filtration Rate (eGFR) | This primary outcome measure was the one from the first interim analysis. | From Baseline to Week 52 |
| Number of Participants With Composite All-cause Allograft Loss or Irreversible Loss of Allograft Function | Composite all-cause allograft loss or irreversible loss of allograft function, defined as time to first occurrence of any of the following components:
(*Total cumulative duration of sustained eGFR < 15 mL/min/1.73 m^2 AND / OR dialysis >= 60 days.) If the eGFR < 15 mL/min/1.73 m^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after >= 60 days from the first measurement. The number of participants with composite all-cause allograft loss or irreversible loss of allograft function are reported here. Time-to-event data were not calculated due to the study's termination. | From Baseline to 4 years |
| Percentage of Participants With Composite All-cause Allograft Loss or Irreversible Loss of Allograft Function | Composite all-cause allograft loss or irreversible loss of allograft function, defined as time to first occurrence of any of the following components:
(*Total cumulative duration of sustained eGFR < 15 mL/min/1.73 m^2 AND / OR dialysis >= 60 days.) If the eGFR < 15 mL/min/1.73 m^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after >= 60 days from the first measurement. The percentage of participants with composite all-cause allograft loss or irreversible loss of allograft function are reported here. | From Baseline to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Composite All-cause Allograft Loss | Composite all-cause allograft loss, defined as, time to first occurrence of any of the following components:
(*Total cumulative duration of sustained eGFR < 15 mL/min/1.73 m^2 AND / OR dialysis >= 60 days.) If the eGFR < 15 mL/min/1.73 m^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after >= 60 days from the first measurement. The number of participants with composite all-cause allograft loss are reported here. |
Not provided
Inclusion criteria:
Age 18-75 years.
Living donor/deceased donor kidney transplant recipients ≥6 months from time of transplant.
Diagnosis of CABMR determined by kidney biopsy and the presence of HLA DSA using single-antigen bead-based assays. For eligibility, kidney biopsy must not be older than 12 months and DSA analysis must be performed no longer than 6 months prior to the start of Screening.
NOTE: • Within 3 months prior to the start of Screening, treatments for ABMR or TCMR, with the exception of steroids*, are not allowed (see Exclusion Criterion 3).
• If treatment for ABMR (including CABMR) or TCMR (other than steroids*) was given between 3 to 12 months of Screening, a repeat kidney biopsy and DSA analysis are required at least 6 weeks after the end of treatment to confirm continuing CABMR and presence of HLA DSA and to determine eligibility.
* A maximum dose of 2g of methylprednisolone intravenously (or dose equivalent of other steroids), followed by a taper to the original maintenance steroid dose is allowed.
The following histopathologic and serologic diagnostic criteria (based on Banff 2015 criteria [Loupy et al, 2017]) must be met for inclusion:
i. Linear C4d staining in peritubular capillaries or medullary vasa recta (Banff scores C4d2 or C4d3 by immunofluorescence on frozen sections, or C4d > 0 by immunohistochemistry on paraffin sections).
ii. At least moderate microvascular inflammation ([glomerulitis score, g + peritubular capillaritis score, ptc] ≥ 2) in the absence of recurrent or de novo glomerulonephritis, although in the presence of acute TCMR, borderline infiltrate, or infection, ptc ≥ 2 alone is not sufficient and g must be ≥ 1.
NOTE: The local pathologist's diagnosis must be reviewed by a central pathologist to confirm eligibility for entry into the study. Biopsies with other histopathologic changes (eg, BKV nephropathy or recurrent glomerulonephritis) may be eligible if concurrent CABMR changes (as detailed above) are present and determined to be the predominant cause of renal dysfunction.
c. Serologic evidence of circulating HLA DSA. NOTE: The local laboratory DSA results must be reviewed and confirmed by the central HLA reviewer during the screening period.
Written informed consent obtained from subject (or legally acceptable representative) before any trial-related procedures.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) - University of Alabama Hospital (UAB Hospital) | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40444214 | Derived | Mayer KA, Budde K, Diebold M, Halloran PF, Bohmig GA. Targeting CD38 in Antibody-Mediated Rejection. Transpl Int. 2025 May 15;38:14343. doi: 10.3389/ti.2025.14343. eCollection 2025. | |
| 39102302 | Derived | Mannon RB, Vincenti FG. Poised for Innovation: Considerations for End Points for New Drug Development in Kidney Transplantation. J Am Soc Nephrol. 2024 Nov 1;35(11):1603-1606. doi: 10.1681/ASN.0000000000000475. Epub 2024 Aug 5. No abstract available. |
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CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
Proposed research should seek to answer a previously unanswered important medical or scientific question.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
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A total of 382 participants were screened, of which 188 were screen failures. Of the screened participants, 194 were randomized in a 1:1 ratio to receive study interventions (Clazakizumab or Placebo).
The study was conducted at 139 study sites in 13 countries: Canada, United States, Austria, Czechia, France, Germany, Hungary, Netherlands, Spain, Sweden, Switzerland, Democratic People's Republic of Korea, and Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clazakizumab | Participants received clazakizumab via subcutaneous (SC) injection once every 4 weeks (Q4W) until the participant: permanently discontinued the investigational product (IP), withdrew from the study, experienced allograft loss, died, or reached the common treatment end date (CTED), whichever occurred first during this study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2023 | Apr 1, 2025 |
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| Physiologic saline solution | Drug | Normal saline |
|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Up to 4 years |
| Percentage of Participants With TEAEs, Serious TEAEs, and AESIs | Up to 4 years |
| Number of Participants Who Tested Positive for Polyoma BK Virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) | Number of participants who tested positive for BKV, CMV or EBV according to the maximum measured viral amount (International Units/mL [IU/mL]) after baseline are reported here. | From baseline up to 4 years |
| Number of Participants With Abnormal Laboratory Test Results | Laboratory tests included liver function test (LFTs), complete blood count (CBC), plasma lipids, high-sensitivity C-reactive protein (hsCRP). Only participants with abnormal laboratory test results are reported here. Here, ULN = upper limit of normal, LLN = lower limit of normal, ALT = Alanine aminotransferase and AST = Aspartate aminotransferase. | Up to 4 years |
| Percentage of Participants With Abnormal Laboratory Test Results | Laboratory tests included LFTs, CBC, plasma lipids, hsCRP. Only percentage of participants with abnormal laboratory test results are reported here. Here, ULN = upper limit of normal, LLN = lower limit of normal, ALT = Alanine aminotransferase and AST = Aspartate aminotransferase. | Up to 4 years |
| Number of Participants With Clinically Significant Change in Vital Signs, Electrocardiograms (ECGs), and Physical Examination | Up to 4 years |
| Number of Participants With Positive Anti-drug Antibodies | Baseline, Weeks 12, 24, and 48 |
| Percentage of Participants With Positive Anti-drug Antibodies | Baseline, Weeks 12, 24, and 48 |
| From Baseline to 4 years |
| Percentage of Participants With Composite All-cause Allograft Loss | Composite all-cause allograft loss, defined as, time to first occurrence of any of the following components:
(*Total cumulative duration of sustained eGFR < 15 mL/min/1.73 m^2 AND / OR dialysis >= 60 days.) If the eGFR < 15 mL/min/1.73 m^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after >= 60 days from the first measurement. The percentage of participants with composite all-cause allograft loss are reported here. | From Baseline to 4 years |
| Number of Participants With Irreversible Loss of Allograft Function | Irreversible loss of allograft function as defined by a 40% decline in eGFR from Baseline sustained for at least 60 days. | From Baseline to 4 years |
| Percentage of Participants With Irreversible Loss of Allograft Function | Irreversible loss of allograft function as defined by a 40% decline in eGFR from Baseline sustained for at least 60 days. | From Baseline to 4 years |
| Number of Participants With Death-censored Allograft Loss | Time to death-censored allograft loss, was defined as occurrence of any of the following components:
(*Total cumulative duration of sustained eGFR < 15 mL/min/1.73 m^2 AND / OR dialysis >= 60 days.) If the eGFR < 15 mL/min/1.73 m^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after >= 60 days from the first measurement. The number of participants with death-censored allograft loss are reported here. | From Baseline to 4 years |
| Percentage of Participants With Death-censored Allograft Loss | Death-censored allograft loss was defined as the occurrence of any of the following components:
(*Total cumulative duration of sustained eGFR < 15 mL/min/1.73 m^2 AND / OR dialysis >= 60 days.) If the eGFR < 15 mL/min/1.73 m^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after >= 60 days from the first measurement. The percentage of participants who experienced death-censored allograft loss are reported here. | From Baseline to 4 years |
| Change From Baseline in Urine Albumin Creatinine Ratio (UACR) | From Baseline to Week 52 |
| Percent Change From Baseline in Mean Fluorescent Intensity for Donor-Specific Antibodies (DSA) | From Baseline to Week 52 |
| Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies | Banff lesion grading scores assess the presence and the degree of histopathological changes in the different compartments of kidney biopsies. Here, the improved category is defined as a decline in the Banff lesion grading score. Participants with improved scores, not improved scores, and missing biopsies for C4d staining, interstitial fibrosis, tubular atrophy, glomerular basement membrane double contours, glomerulitis and peritubular capillaritis are reported for this outcome measure. | From Baseline to Week 52 |
| Incidence of Acute Rejection Episodes of T Cell-mediated Rejection (TCMR) and Antibody-mediated Rejection (ABMR) | Number of participants who had at least one acute rejection episode (TCMR or ABMR) are reported for this outcome measure. | Baseline up to End of treatment (up to approximately 4 years) |
| Overall Participant Survival | Number of participants who were alive up to Week 52 are reported for this outcome measure. | Up to Week 52 |
| Maximum Concentration at Steady State (Cmax ss) of CSL300 | A subset of participants (out of the enrolled participants in the main study) had the option to participate in a pharmacokinetic (PK)/ Pharmacodynamic (PD) sub-study. | Up to Week 24 |
| Trough Concentrations at Steady State (Ctrough ss) of CSL300 | A subset of participants (out of the enrolled participants in the main study) had the option to participate in a PK/PD sub-study. | Up to Week 24 |
| Area Under the Concentration-time Curve (AUC0-tau) at Steady State of CSL300 | A subset of participants (out of the enrolled participants in the main study) had the option to participate in a PK/PD sub-study. | Up to Week 24 |
| Time of Maximum Concentration at Steady State (Tmax ss) of CSL300 | A subset of participants (out of the enrolled participants in the main study) had the option to participate in a PK/PD sub-study. | Up to Week 24 |
| Mayo Clinic Hospital |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Keck Medical Center Of USC | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| UCLA Kidney Transplant Research Program | Los Angeles | California | 90095 | United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| California Institute of Renal Research | San Diego | California | 92123 | United States |
| North America Research Institute | San Dimas | California | 91773 | United States |
| California Pacific Medical Center | San Francisco | California | 94109 | United States |
| Kaiser Permanente | San Francisco | California | 94118 | United States |
| University of California, San Francisco Medical Center | San Francisco | California | 94143 | United States |
| University Of Colorado Hospital - Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| Tampa General Medical Group | Tampa | Florida | 33606 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center - University Cardiovascular Surgeons | Chicago | Illinois | 60612 | United States |
| Indiana University (IU) Health Physicians - Kidney Diseases Clinic - Medical Diagnostic Center Location | Indianapolis | Indiana | 46202 | United States |
| Unity Point Health | Des Moines | Iowa | 50309 | United States |
| Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Louisville Research Foundation | Louisville | Kentucky | 40202 | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Massachusetts General Cancer Center | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55095 | United States |
| Washington University School of Medicine - Infectious Diseases (WU ID) Clinic | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | United States |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Erie County Medical Center Corp. | Buffalo | New York | 14215 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| New York Presbyterian Hospital / Weill Cornell Medical Center | New York | New York | 10021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Duke Cancer Institute | Durham | North Carolina | 27710 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| The Ohio State University, Comprehensive Transplant Center | Columbus | Ohio | 43210 | United States |
| University of Cincinnati | Toledo | Ohio | 43614 | United States |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| Central Pennsylvania Transplant Foundation | Harrisburg | Pennsylvania | 17104 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02906 | United States |
| Renal Disease Research Institute | Dallas | Texas | 75204 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75235 | United States |
| Methodist Healthcare System of San Antonio | San Antonio | Texas | 78229 | United States |
| VCU Health | Richmond | Virginia | 23298 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| University of Wisconsin School of Medicine and Public Health (UWSMPH) | Madison | Wisconsin | 53705 | United States |
| Medical College of WI Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| WSLHD, Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| The University of Queensland - Princess Alexandra Hospital (PAH) | Woolloongabba | Queensland | 4102 | Australia |
| Monash Health Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| The Royal Melbourne Hospital | Parkville | Victoria | 3064 | Australia |
| Sir Charles Gairdner Hospital (SCGH) | Nedlands | Western Australia | 6009 | Australia |
| Royal Adelaide Hospital | Adelaide | Australia |
| Royal Prince Alfred Hospital | Camperdown | Australia |
| Monash Medical Centre | Clayton | Australia |
| Linear Clinical Research | Nedlands | Australia |
| Westmead Hospital | Westmead | Australia |
| Princess Alexandra Hospital | Woolloongabba | Australia |
| LKH-Universität Hospital Graz | Graz | Austria |
| Universitätsklinik für Innere Medizin III Innsbruck | Innsbruck | Austria |
| Medizinische Universität Wien, Allgemeines Krankenhaus der S | Vienna | Austria |
| UZ Antwerpen | Edegem | Belgium |
| UZ Leuven | Leuven | Belgium |
| Centre Hospitalier Universitaire Sart Tilman | Liège | Belgium |
| Vancouver General Hospital - Gordon & Leslie Diamond Centre | Vancouver | British Columbia | V5Z 1M9 | Canada |
| St. Paul's Hospital, Providence Health Care, Univ. Of British Columbia | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Shared Health Inc. operating as the Health Sciences Centre | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| St. Michael's Health Centre | Toronto | Ontario | M5C 2T2 | Canada |
| McGill University Health Center | Montreal | Quebec | H4A 3J1 | Canada |
| St Paul's Hospital Foundation | Saskatoon | Saskatchewan | S7M 0Z9 | Canada |
| Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM) | Montreal | Canada |
| University Health Network | Toronto | Canada |
| Centrum kardiovaskulární a transplantacní chirurgie Brno | Brno-střed | Czechia |
| Fakultní Nemocnice Olomouc | Olomouc | Czechia |
| IKEM | Prague | 14000 | Czechia |
| CHU GRENOBLE ALPES - Consultation Néphrologie Bureau des ARC (Côté Chartreuse, Rez-de-Chaussée Haut) | Grenoble | Grenoble Cédex 09 | 38043 | France |
| Néphrologie - Pavillon Sainte Venise - CHU de Rouen - Hôpital de Bois Guillaume | Bois-Guillaume | 76230 | France |
| Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin | Bordeaux | 33076 | France |
| Centre Hospitalier Universitaire (CHU) - Hopital Henri Mondor | Créteil | 94010 | France |
| Hopital Kremlin Bicetre | Le Kremlin-Bicêtre | 94270 | France |
| Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren | Limoges | 87042 | France |
| Hopital Edouard Herriot | Lyon | 69003 | France |
| Hopital de la Conception - APHM | Marseille | 13005 | France |
| Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve | Montpellier | 34295 | France |
| CHU de Nantes - Houtel Dieu | Nantes | 44093 | France |
| Centre Hospitalier Universitaire de Nice, Hopital Pasteur 2 | Nice | 06001 | France |
| Hospital Saint-Louis - APHP | Paris | 75010 | France |
| Hopital Necker Enfants Malades | Paris | 75015 | France |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | 86021 | France |
| Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes | Strasbourg | 67098 | France |
| CHU Rangueil | Toulouse | 31059 | France |
| Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau | Tours | 37044 | France |
| Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) | Berlin | 10117 | Germany |
| Debreceni Egyetem, Klinikai Központ, Auguszta | Debrecen | 4032 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary |
| Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC) | Amsterdam | 1105 AZ | Netherlands |
| Amsterdam UMC location AMC | Amsterdam | 1105AZ | Netherlands |
| University Medical Center Groningen | Groningen | 9713 GZ | Netherlands |
| Leiden University Medical Center (LUMC) | Leiden | 2333 ZA | Netherlands |
| Maastricht University Medical Centre | Maastricht | 6248 HX | Netherlands |
| Radboud UMC | Nijmegen | Netherlands |
| Erasmus University Medical Center | Rotterdam | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands |
| Auckland City Hospital | Auckland | New Zealand |
| Pusan National University Hospital | Busan | South Korea |
| Keimyung Dongsan Medical Center | Daegu | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Kangdong Sacred Heart Hospital | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Kosin University Gospel Hospital | Seoul | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Bundang Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital Yonsei University | Seoul | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | South Korea |
| Hospital Del Mar | Barcelona | 8003 | Spain |
| Hospital Vall d'Hebron | Barcelona | 8035 | Spain |
| Hospital Clinic Barcelona | Barcelona | 8036 | Spain |
| Hospital Universitari de Bellvitge | Barcelona | 8907 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias | Madrid | 28041 | Spain |
| Hospital Universitario Marques De Valdecilla | Santander | 39008 | Spain |
| Centro Hospital Universitario Dr. Preset | Valencia | 46017 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Karolinska University Hospital | Huddinge | SE-141 86 | Sweden |
| Karolinska University Hospital | Solna | Sweden |
| Uppsala Universitet - Akademiska Sjukhuset | Uppsala | 75185 | Sweden |
| Uppsala Universitet - Akademiska Sjukhuset | Uppsala | Sweden |
| Hualien Tzu Chi Hospital | Hualien City | Taiwan |
| Far Eastern Memorial Hospital | New Taipei City | Taiwan |
| Taichung Veterans General Hospital | Taichang | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan | Taiwan |
| 36550562 | Derived | Nickerson PW, Bohmig GA, Chadban S, Kumar D, Mannon RB, van Gelder T, Lee JC, Adler S, Chong E, Djamali A. Clazakizumab for the treatment of chronic active antibody-mediated rejection (AMR) in kidney transplant recipients: Phase 3 IMAGINE study rationale and design. Trials. 2022 Dec 22;23(1):1042. doi: 10.1186/s13063-022-06897-3. |
| 35969004 | Derived | Borski A, Eskandary F, Haindl S, Doberer K, Muhlbacher J, Mayer KA, Budde K, Halloran PF, Chong E, Jilma B, Bohmig GA, Wahrmann M. Anti-interleukin-6 Antibody Clazakizumab in Antibody-mediated Renal Allograft Rejection: Accumulation of Antibody-neutralized Interleukin-6 Without Signs of Proinflammatory Rebound Phenomena. Transplantation. 2023 Feb 1;107(2):495-503. doi: 10.1097/TP.0000000000004285. Epub 2023 Jan 26. |
| 35497778 | Derived | Jordan SC, Ammerman N, Choi J, Huang E, Najjar R, Peng A, Sethi S, Sandhu R, Atienza J, Toyoda M, Ge S, Lim K, Gillespie M, Zhang X, Haas M, Vo A. Evaluation of Clazakizumab (Anti-Interleukin-6) in Patients With Treatment-Resistant Chronic Active Antibody-Mediated Rejection of Kidney Allografts. Kidney Int Rep. 2022 Feb 9;7(4):720-731. doi: 10.1016/j.ekir.2022.01.1074. eCollection 2022 Apr. |
| FG001 |
| Placebo |
Participants received Placebo by SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study. |
| COMPLETED | Participants that reached the primary endpoint of allograft loss or death. |
|
| NOT COMPLETED |
|
|
Analysis was performed on randomized set, which included all participants who were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Clazakizumab | Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study. |
| BG001 | Placebo | Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline to Week 52 in Estimated Glomerular Filtration Rate (eGFR) | This primary outcome measure was the one from the first interim analysis. | Analysis was performed on the intent-to-treat (ITT) analysis set. The ITT analysis set consisted of all randomized participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR. | Posted | Least Squares Mean | 95% Confidence Interval | milliliter per minute per 1.73 meter^2 | From Baseline to Week 52 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Composite All-cause Allograft Loss or Irreversible Loss of Allograft Function | Composite all-cause allograft loss or irreversible loss of allograft function, defined as time to first occurrence of any of the following components:
(*Total cumulative duration of sustained eGFR < 15 mL/min/1.73 m^2 AND / OR dialysis >= 60 days.) If the eGFR < 15 mL/min/1.73 m^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after >= 60 days from the first measurement. The number of participants with composite all-cause allograft loss or irreversible loss of allograft function are reported here. Time-to-event data were not calculated due to the study's termination. | Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR. | Posted | Count of Participants | Participants | No | From Baseline to 4 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Composite All-cause Allograft Loss or Irreversible Loss of Allograft Function | Composite all-cause allograft loss or irreversible loss of allograft function, defined as time to first occurrence of any of the following components:
(*Total cumulative duration of sustained eGFR < 15 mL/min/1.73 m^2 AND / OR dialysis >= 60 days.) If the eGFR < 15 mL/min/1.73 m^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after >= 60 days from the first measurement. The percentage of participants with composite all-cause allograft loss or irreversible loss of allograft function are reported here. | Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR. | Posted | Number | percentage of participants | From Baseline to 4 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Analysis was performed on the safety analysis set (SAS). The SAS consisted of all randomized participants who had received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Up to 4 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With TEAEs, Serious TEAEs, and AESIs | Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to 4 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Tested Positive for Polyoma BK Virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) | Number of participants who tested positive for BKV, CMV or EBV according to the maximum measured viral amount (International Units/mL [IU/mL]) after baseline are reported here. | Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Count of Participants | Participants | No | From baseline up to 4 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Abnormal Laboratory Test Results | Laboratory tests included liver function test (LFTs), complete blood count (CBC), plasma lipids, high-sensitivity C-reactive protein (hsCRP). Only participants with abnormal laboratory test results are reported here. Here, ULN = upper limit of normal, LLN = lower limit of normal, ALT = Alanine aminotransferase and AST = Aspartate aminotransferase. | Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. Here, 'overall number of participants analyzed' = participants with evaluable data for this outcome measure. | Posted | Count of Participants | Participants | No | Up to 4 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Abnormal Laboratory Test Results | Laboratory tests included LFTs, CBC, plasma lipids, hsCRP. Only percentage of participants with abnormal laboratory test results are reported here. Here, ULN = upper limit of normal, LLN = lower limit of normal, ALT = Alanine aminotransferase and AST = Aspartate aminotransferase. | Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. Here, 'overall number of participants analyzed' = participants with evaluable data for this outcome measure. | Posted | Number | percentage of participants | Up to 4 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Change in Vital Signs, Electrocardiograms (ECGs), and Physical Examination | Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Up to 4 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Positive Anti-drug Antibodies | Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. Here, 'overall number of participants' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint. | Posted | Count of Participants | Participants | No | Baseline, Weeks 12, 24, and 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Positive Anti-drug Antibodies | Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. Here, 'overall number of participants' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint. | Posted | Number | percentage of participants | Baseline, Weeks 12, 24, and 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite All-cause Allograft Loss | Composite all-cause allograft loss, defined as, time to first occurrence of any of the following components:
(*Total cumulative duration of sustained eGFR < 15 mL/min/1.73 m^2 AND / OR dialysis >= 60 days.) If the eGFR < 15 mL/min/1.73 m^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after >= 60 days from the first measurement. The number of participants with composite all-cause allograft loss are reported here. | Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR. | Posted | Count of Participants | Participants | No | From Baseline to 4 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Composite All-cause Allograft Loss | Composite all-cause allograft loss, defined as, time to first occurrence of any of the following components:
(*Total cumulative duration of sustained eGFR < 15 mL/min/1.73 m^2 AND / OR dialysis >= 60 days.) If the eGFR < 15 mL/min/1.73 m^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after >= 60 days from the first measurement. The percentage of participants with composite all-cause allograft loss are reported here. | Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR. | Posted | Number | percentage of participants | From Baseline to 4 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Irreversible Loss of Allograft Function | Irreversible loss of allograft function as defined by a 40% decline in eGFR from Baseline sustained for at least 60 days. | Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR. | Posted | Count of Participants | Participants | No | From Baseline to 4 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Irreversible Loss of Allograft Function | Irreversible loss of allograft function as defined by a 40% decline in eGFR from Baseline sustained for at least 60 days. | Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR. | Posted | Number | percentage of participants | From Baseline to 4 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Death-censored Allograft Loss | Time to death-censored allograft loss, was defined as occurrence of any of the following components:
(*Total cumulative duration of sustained eGFR < 15 mL/min/1.73 m^2 AND / OR dialysis >= 60 days.) If the eGFR < 15 mL/min/1.73 m^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after >= 60 days from the first measurement. The number of participants with death-censored allograft loss are reported here. | Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR. | Posted | Count of Participants | Participants | No | From Baseline to 4 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Death-censored Allograft Loss | Death-censored allograft loss was defined as the occurrence of any of the following components:
(*Total cumulative duration of sustained eGFR < 15 mL/min/1.73 m^2 AND / OR dialysis >= 60 days.) If the eGFR < 15 mL/min/1.73 m^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after >= 60 days from the first measurement. The percentage of participants who experienced death-censored allograft loss are reported here. | Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all randomized participants who received at least 1 dose of the investigational product, had a Baseline assessment, and had at least 1 post-baseline assessment of eGFR. | Posted | Number | percentage of participants | From Baseline to 4 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Urine Albumin Creatinine Ratio (UACR) | Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | gram per mole | From Baseline to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Mean Fluorescent Intensity for Donor-Specific Antibodies (DSA) | Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. The Overall Number of Participants Analyzed reported here reflects all participants who were analyzed, which includes all (N = 93 Clazakizumab and 100 Placebo) participants assessed at baseline to determine DSA class I or II. Here, 'Number Analyzed' = the number of participants in Class I or II classified at baseline who had available MFI data at Week 52. | Posted | Median | Inter-Quartile Range | percent change | From Baseline to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies | Banff lesion grading scores assess the presence and the degree of histopathological changes in the different compartments of kidney biopsies. Here, the improved category is defined as a decline in the Banff lesion grading score. Participants with improved scores, not improved scores, and missing biopsies for C4d staining, interstitial fibrosis, tubular atrophy, glomerular basement membrane double contours, glomerulitis and peritubular capillaritis are reported for this outcome measure. | Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all randomized participants who received at least 1 dose of the investigational product, had a Baseline assessment, and had at least 1 post-baseline assessment of eGFR. | Posted | Count of Participants | Participants | From Baseline to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Acute Rejection Episodes of T Cell-mediated Rejection (TCMR) and Antibody-mediated Rejection (ABMR) | Number of participants who had at least one acute rejection episode (TCMR or ABMR) are reported for this outcome measure. | Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all randomized participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR. | Posted | Count of Participants | Participants | Baseline up to End of treatment (up to approximately 4 years) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Participant Survival | Number of participants who were alive up to Week 52 are reported for this outcome measure. | Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all randomized participants who received at least 1 dose of the investigational product, had a Baseline assessment, and had at least 1 post-baseline assessment of eGFR. | Posted | Count of Participants | Participants | No | Up to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration at Steady State (Cmax ss) of CSL300 | A subset of participants (out of the enrolled participants in the main study) had the option to participate in a pharmacokinetic (PK)/ Pharmacodynamic (PD) sub-study. | Analysis was performed on the PK/ PD analysis set. The PK/PD substudy analysis set consisted of all participants in the SAS who consented to be a part of the PK / PD substudy and had at least 1 quantifiable PK concentration of investigational product after administration. Here, "overall number of participants analyzed' = participants with available data for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | Up to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Concentrations at Steady State (Ctrough ss) of CSL300 | A subset of participants (out of the enrolled participants in the main study) had the option to participate in a PK/PD sub-study. | Analysis was performed on the PK/PD analysis set. The PK/PD substudy analysis set consisted of all participants in the SAS who consented to be a part of the PK / PD substudy and had at least 1 quantifiable PK concentration of investigational product after administration. Here, "overall number of participants analyzed' = participants with available data for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | Up to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve (AUC0-tau) at Steady State of CSL300 | A subset of participants (out of the enrolled participants in the main study) had the option to participate in a PK/PD sub-study. | Analysis was performed on the PK/PD analysis set. The PK/PD substudy analysis set consisted of all participants in the SAS who consented to be a part of the PK / PD substudy and had at least 1 quantifiable PK concentration of investigational product after administration. Here, "overall number of participants analyzed' = participants with available data for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | days*nanograms per milliliter | Up to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time of Maximum Concentration at Steady State (Tmax ss) of CSL300 | A subset of participants (out of the enrolled participants in the main study) had the option to participate in a PK/PD sub-study. | Analysis was performed on the PK/PD analysis set. The PK/PD substudy analysis set consisted of all participants in the SAS who consented to be a part of the PK / PD substudy and had at least 1 quantifiable PK concentration of investigational product after administration. Here, "overall number of participants analyzed' = participants with available data for this outcome measure. | Posted | Median | Full Range | day | Up to Week 24 |
|
|
Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clazakizumab | Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study. | 3 | 93 | 39 | 93 | 81 | 93 |
| EG001 | Placebo | Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study. | 1 | 100 | 39 | 100 | 80 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Arteriovenous graft site infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Pyelonephriti | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Viral diarrhoea | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Terminal ileitis | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Complications of transplanted pancreas | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Transplant failure | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm ruptured | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Lymphatic obstruction | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Chronic allograft nephropathy | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Kidney transplant rejection | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Angiopathy | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Renal and pancreas transplant rejection | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Immunosuppressant drug level decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Immunosuppressant drug level increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
|
This study was not able to complete secondary endpoint assessments as planned. The study was terminated due to futility after the planned interim analysis based on the change in eGFR from baseline to Week 52 and analysis was conducted where feasible using the data collected at Week 52 or by the time of study termination.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | CSL Behring | 16108784000 | clinicaltrials@cslbehring.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2023 | Apr 1, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000604955 | clazakizumab |
Not provided
Not provided
Not provided
| Male |
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| Hispanic, Latino/a or of Spanish origin |
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| Not reported |
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| Unknown |
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| Black or African American |
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| Korean |
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| Other |
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| Asian Indian |
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| Other Asian |
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| American or Alaskan Native |
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| Filipino |
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| Missing |
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| Placebo |
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study. |
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Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
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| Participants |
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| Participants |
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| Missing biopsies |
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| Missing biopsies |
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| Missing biopsies |
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| Missing biopsies |
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| Missing biopsies |
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