Clinical trial NCT04523220: Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis
Official title: A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study to Assess the Safety and Tolerability of Monthly Subcutaneous Administrations of a Low and High Dose Cohort of Osocimab to ESRD Patients on Regular Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End-stage Renal Disease
Prevention of Thromboembolic Events
Hemodialysis
Hemodiafiltration
Keywords: End-stage renal disease (ESRD)
Hemodialysis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-08-21
Enrollment: 704
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels diseases. Osocimab is a human monoclonal antibody under development for the prevention of events caused by blood clots like heart attack, stroke and death due to heart or blood vessels diseases. It works by binding to and blocking the activated form of clotting factor XI which increases the formation and stability of clots. Researchers also want to find out how drug Osocimab works in human body and how the body absorbs, distributes and excretes the drug.

Participants in this study will receive monthly injection of either Osocimab at a lower-dose or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.


Eligibility criteria: Inclusion Criteria:

* Participants must be at least 18 years of age
* Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for ≥3 months, receiving dialysis at least 9 hours a week and stable in the view of the investigator
* Body weight of at least 50 kg
* Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

* Recent (\<6 months before screening) clinically significant bleeding
* Hemoglobin (Hb) \< 9.0 g/dL at screening
* Platelet count \< 100 x 10\^9/L
* aPTT or PT \> ULN (upper limit of normal)
* Hepatic disease associated with ALT \> 3x ULN, or total bilirubin \>2x ULN with direct bilirubin \> 20% of the total
* Sustained uncontrolled hypertension (diastolic blood pressure ≥100 mmHg and/or systolic blood pressure ≥ 180 mmHg)
* Known intracranial neoplasm, arteriovenous malformation or aneurysm
* Known bleeding disorders e.g. von-Willebrand disease or Hemophilia A, B or C
* Recent (\<3 months before screening) thromboembolic event, e.g. acute coronary syndrome, stroke or VTE (except dialysis access thrombosis)
* Recent (\<3 months before screening) major surgery or scheduled major surgery during study participation
* Scheduled living donor renal transplant during study participation
* Persistent heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher
* Receiving antiplatelet therapy except daily ASA ≤ 150 mg/day
* Receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure

Primary outcomes:
measure: Cumulative Incidence Risk of the First Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) Events as Assessed by Blinded Central Independent Adjudication Committee (CIAC)
timeFrame: From the first dose of study intervention up till 30 days after last study intervention in the main treatment period, up to 6 months
measure: Cumulative Incidence Risk of Composite of Moderate and Severe Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From the first dose of study intervention up until 30 days after last study intervention in the main treatment period, up to 6 months
Secondary outcomes:
measure: Ratio of Activated Partial Thromboplastin Time (aPTT) at 6 Months Trough Levels Versus Baseline.
timeFrame: At 6 months (Visit 19 / Day 30 of the 6th month)
measure: Ratio of Factor XI (FXI) Activity at 6 Months Trough Levels Versus Baseline
timeFrame: At 6 months (Visit 19 / Day 30 of the 6th month)
Other outcomes:
Locations:
city: Azusa
country: United States
facility: North America Research Institute - Azusa
state: California
city: Brawley
country: United States
facility: Fresenius Kidney Care - Brawley
state: California
city: Encino
country: United States
facility: DaVita South Valley Dialysis
state: California
city: La Mesa
country: United States
facility: Fresenius Kidney Care - La Mesa
state: California
city: Los Angeles
country: United States
facility: East L.A. Dialysis Center
state: California
city: Riverside
country: United States
facility: Van Buren Dialysis Center
state: California
city: San Diego
country: United States
facility: Fresenius Kidney Care Kearny Mesa
state: California
city: San Diego
country: United States
facility: FMC San Ysidro
state: California
city: West Covina
country: United States
facility: Queen's Dialysis Unit
state: California
city: Waterbury
country: United States
facility: DaVita Greater Waterbury Dialysis
state: Connecticut
city: Ellenton
country: United States
facility: ARA Plantation Dialysis, LLC
state: Florida
city: Augusta
country: United States
facility: ARA Augusta
state: Georgia
city: Caldwell
country: United States
facility: Liberty Dialysis- Caldwell
state: Idaho
city: Evergreen Park
country: United States
facility: Fresenius Kidney Care Evergreen Park
state: Illinois
city: Baton Rouge
country: United States
facility: Fresenius Kidney Care Baton Rouge Mancuso Lane
state: Louisiana
city: Shreveport
country: United States
facility: Fresenius Kidney Care South Dialysis
state: Louisiana
city: Holyoke
country: United States
facility: ARA Holyoke Dialysis Center
state: Massachusetts
city: Kansas City
country: United States
facility: Davita Hospital Hill Dialysis
state: Missouri
city: Albuquerque
country: United States
facility: Renal Medicine Associates
state: New Mexico
city: Durham
country: United States
facility: Durham Nephrology Associates, Pa
state: North Carolina
city: Austin
country: United States
facility: Waterloo Dialysis
state: Texas
city: Austin
country: United States
facility: Fresenius North Austin Dialysis Center
state: Texas
city: Houston
country: United States
facility: Fresenius Kidney Care - Mission Bend (FMCNA #3971)
state: Texas
city: Sugar Land
country: United States
facility: Fresenius Kidney Care Sugar Land
state: Texas
city: Saint George
country: United States
facility: Liberty Dialysis St. George
state: Utah
city: Hampton
country: United States
facility: DaVita Butler Farm Dialysis
state: Virginia
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Box Hill
country: Australia
facility: Eastern Health Integrated Renal Service
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
state: Kärnten
city: Salzburg
country: Austria
facility: Privatklinik Wehrle-Diakonissen
city: Wien
country: Austria
facility: Klinik Landstraße - Krankenhaus Rudolfstiftung
city: Wien
country: Austria
facility: Universitätsklinikum AKH Wien
city: Baudour
country: Belgium
facility: Epicura
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis - St-Elisabethkliniek
city: Gent
country: Belgium
facility: AZ St-Lucas Campus St-Lucas
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liege
country: Belgium
facility: CHU de Liege | CHR Citadel - Department of Nephrology
city: Sint-niklaas
country: Belgium
facility: AZ Nikolaas Campus Sint-Niklaas
city: Dupnitsa
country: Bulgaria
facility: MHAT Sveti Ivan Rilski 2003
city: Haskovo
country: Bulgaria
facility: MHAT Haskovo
city: Ruse
country: Bulgaria
facility: UMHAT Kanev AD
city: Shumen
country: Bulgaria
facility: MHAT Shumen AD
city: Vratsa
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Hristo Botev AD
city: Liberec
country: Czechia
facility: Krajska Nemocnice Liberec
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Plzen
country: Czechia
facility: Privamed s.r.o.
city: Sokolov
country: Czechia
facility: Fresenius Nephro Care s.r.o. - Sokolov
city: Arta
country: Greece
facility: General Hospital of Arta
city: Athens
country: Greece
facility: HIPPOKRATION General Hospital of Athens
city: Athens
country: Greece
facility: General Hospital of Athens LAIKO
city: Ioannina
country: Greece
facility: Ioannina University General Hospital
city: Larissa
country: Greece
facility: University General Hospital of Larissa
city: Thessaloniki
country: Greece
facility: Hippokration General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Papageorgiou
city: Baja
country: Hungary
facility: Bajai Szent Rokus Korhaz
city: Budapest
country: Hungary
facility: Fresenius Medical Care Egeszsegugyi Kft.
city: Budapest
country: Hungary
facility: Eszak-Pesti Centrumkorhaz-Honvedkorhaz
city: Hodmezovasarhely
country: Hungary
facility: Csongrad Megyei Egeszsegugyi Ellato Kozpont,Hodmezovasarhely
city: Keszthely
country: Hungary
facility: Keszthelyi Korhaz
city: Miskolc
country: Hungary
facility: Fresenius Medical Care Egeszsegugyi Kft.
city: Pecs
country: Hungary
facility: Fresenius Medical Care Egeszsegugyi Kft.
city: Ashkelon
country: Israel
facility: Barzilai Medical Center | Nephrology & Hypertension Dept.
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Nahariya
country: Israel
facility: Health Corporation of Galilee Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center, HaSharon (Golda) Campus
city: Petah Tikva
country: Israel
facility: Clalit Health Services Rabin Medical Center-Beilinson Campus
city: Tiberius
country: Israel
facility: Poriya Medical Center | Nephrology and Hypertension Dept.
city: Zerifin
country: Israel
facility: Shamir Medical Center (Assaf Harofeh)
city: Bologna
country: Italy
facility: A.O.U. di Bologna Policlinico S.Orsola Malpighi
state: Emilia-Romagna
city: Parma
country: Italy
facility: A.O.U. di Parma
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: AUSL-IRCCS di Reggio Emilia
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: Lazio
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
state: Liguria
city: Pavia
country: Italy
facility: IRCCS Istituti Clinici Scientifici Maugeri SpA SB
state: Lombardia
city: Firenze
country: Italy
facility: A.O.U. Careggi
state: Toscana
city: Sashima-gun
country: Japan
facility: Ibaraki Seinan Medical Center Hospital
state: Ibaraki
city: Tsuchiura
country: Japan
facility: Tsuchiura Beryl Clinic
state: Ibaraki
city: Tsuchiura
country: Japan
facility: Ohishi Naika Clinic
state: Ibaraki
city: Tsukuba
country: Japan
facility: Kikuchi Medical Clinic
state: Ibaraki
city: Shiraishi
country: Japan
facility: Katta General Hospital
state: Miyagi
city: Nagaoka
country: Japan
facility: Nagaoka Red Cross Hospital
state: Niigata
city: Koshigaya
country: Japan
facility: Saiyu Clinic
state: Saitama
city: Kanuma
country: Japan
facility: Takemura Medical Nephro Clinic
state: Tochigi
city: Setagaya-ku
country: Japan
facility: Futakotamagawaekimae clinic
state: Tokyo
city: Ube
country: Japan
facility: Saint Hill Hospital
state: Yamaguchi
city: Kumamoto
country: Japan
facility: Akebono Clinic
city: Kyoto
country: Japan
facility: Kyoto Station Takeda Dialysis Clinic
city: Osaka
country: Japan
facility: Akagaki Clinic
city: Yamagata
country: Japan
facility: Yabuki Hospital
city: Kaunas
country: Lithuania
facility: LUHS Kauno Hospital (Josvainiu str.)
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum (AMC)
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis, Dordwijk
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis | Neurology Department
city: Kielce
country: Poland
facility: Wojewodzki Szpital Zespolony
city: Olkusz
country: Poland
facility: Stacja Dializ Olkusz
city: Swiecie
country: Poland
facility: NZOZ Nowy Szpital w Swieciu Sp. z o.o.
city: Warszawa
country: Poland
facility: Stacja Dializ W-wa Mangalia
city: Zyrardow
country: Poland
facility: Stacja Dializ Zyrardow
city: Gaeiras - Obidos
country: Portugal
facility: Eurodial Obidos (DaVita)
state: Leiria
city: Amadora
country: Portugal
facility: SPD - Amadora (Diaverum Amadora)
state: Lisboa
city: Carnaxide
country: Portugal
facility: CHLO - Hospital Santa Cruz
state: Lisboa
city: Cascais
country: Portugal
facility: Pluribus Dialise - Cascais (DaVita)
state: Lisboa
city: Sacavem
country: Portugal
facility: Pluribus Dialise - Sacavem (DaVita)
state: Lisboa
city: Canelas
country: Portugal
facility: Caledial - Centro de Hemodialise de Gaia
state: Porto
city: Torres Novas
country: Portugal
facility: Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department
state: Santarém
city: Aveiro
country: Portugal
facility: Diaverum Aveiro
city: Leiria
country: Portugal
facility: Eurodial Leiria (DaVita)
city: Lisboa
country: Portugal
facility: NephroCare APDP
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Hospital
city: Kolomna
country: Russian Federation
facility: LLC Dialysis center
city: Krasnodar
country: Russian Federation
facility: LLC Fresenius medical care Kuban
city: Mytishchi
country: Russian Federation
facility: LLC Dialysis center
city: Orenburg
country: Russian Federation
facility: City Clinical Hospital #1 Orenburg
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital n.a. V.A. Baranov
city: St. Petersburg
country: Russian Federation
facility: Kupchinsky center for outpatient dialysis
city: St. Petersburg
country: Russian Federation
facility: LLC B. Brown Avitum Russland Clinics
city: St. Petersburg
country: Russian Federation
facility: City Hospital #31
city: Yaroslavl
country: Russian Federation
facility: LLC Yaroslavl dialysis center
city: Yekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital #1
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
state: A Coruña
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Manresa
country: Spain
facility: Hospital Althaia, Xarxa Assistencial de Manresa
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos | Nefrologia
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi
city: Aydin
country: Turkey
facility: Adnan Menderes Universitesi Tip fakultesi
city: Istanbul
country: Turkey
facility: Turk Bobrek Vakfi Memorial Hizmet Hastanesi
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi
city: Malatya
country: Turkey
facility: Inonu Universitesi Tip Fakultesi
city: Brovary
country: Ukraine
facility: Brovarskaya multidisciplinary clinical hospital
city: Cherkasy
country: Ukraine
facility: Medical center LLC " Fresenius medical care Ukraine"
city: Dnipro
country: Ukraine
facility: Dnepropetrovsk regional hospital n.a. I. I. Mechnikov
city: Ivano-Frankivsk
country: Ukraine
facility: Regional Clinical Hospital - Ivano-Frankivsk
city: Kharkiv
country: Ukraine
facility: Kharkiv regional Clinical Centre of urology and nephrology
city: Kyiv
country: Ukraine
facility: Kyiv City Center of Nephrology and Dialysis
city: Kyiv
country: Ukraine
facility: State Institution "Institute of Nephrology" NAMS of Ukraine
city: Lutsk
country: Ukraine
facility: Lutsk city clinical hospital
city: Mykolaiv
country: Ukraine
facility: Mykolaiv Regional Clinical Hospital
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
city: Uzhgorod
country: Ukraine
facility: Transcarpatian Regional Clinical Hospital
city: Vinnytsia
country: Ukraine
facility: Vinnitsa Regional Clinical Hospital im. N.I. Pirogov
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhia Regional Clinical Hospital
Study officials:
References: