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Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis (CONVERT)

Primary Purpose

End-stage Renal Disease, Prevention of Thromboembolic Events, Hemodialysis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BAY1213790 (Osocimab)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease focused on measuring End-stage renal disease (ESRD), Hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 109/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

Sites / Locations

  • North America Research Institute - Azusa
  • Fresenius Kidney Care - Brawley
  • DaVita South Valley Dialysis
  • Fresenius Kidney Care - La Mesa
  • East L.A. Dialysis Center
  • Van Buren Dialysis Center
  • Fresenius Kidney Care Kearny Mesa
  • FMC San Ysidro
  • Queen's Dialysis Unit
  • DaVita Greater Waterbury Dialysis
  • ARA Plantation Dialysis, LLC
  • ARA Augusta
  • Liberty Dialysis- Caldwell
  • Fresenius Kidney Care Evergreen Park
  • Fresenius Kidney Care Baton Rouge Mancuso Lane
  • Fresenius Kidney Care South Dialysis
  • ARA Holyoke Dialysis Center
  • Davita Hospital Hill Dialysis
  • Renal Medicine Associates
  • Durham Nephrology Associates, Pa
  • Waterloo Dialysis
  • Fresenius North Austin Dialysis Center
  • Fresenius Kidney Care - Mission Bend (FMCNA #3971)
  • Fresenius Kidney Care Sugar Land
  • Liberty Dialysis St. George
  • DaVita Butler Farm Dialysis
  • Sydney Adventist Hospital
  • Westmead Hospital
  • Eastern Health Integrated Renal Service
  • John Hunter Hospital
  • Klinikum Klagenfurt am Wörthersee
  • Privatklinik Wehrle-Diakonissen
  • Klinik Landstraße - Krankenhaus Rudolfstiftung
  • Universitätsklinikum AKH Wien
  • Epicura
  • Imeldaziekenhuis - St-Elisabethkliniek
  • AZ St-Lucas Campus St-Lucas
  • UZ Leuven Gasthuisberg
  • CHU de Liege | CHR Citadel - Department of Nephrology
  • AZ Nikolaas Campus Sint-Niklaas
  • MHAT Sveti Ivan Rilski 2003
  • MHAT Haskovo
  • UMHAT Kanev AD
  • MHAT Shumen AD
  • Multiprofile Hospital for Active Treatment Hristo Botev AD
  • Krajska Nemocnice Liberec
  • Fakultni nemocnice Ostrava
  • Privamed s.r.o.
  • Fresenius Nephro Care s.r.o. - Sokolov
  • General Hospital of Arta
  • HIPPOKRATION General Hospital of Athens
  • General Hospital of Athens LAIKO
  • Ioannina University General Hospital
  • University General Hospital of Larissa
  • Hippokration General Hospital of Thessaloniki
  • General Hospital of Thessaloniki Papageorgiou
  • Bajai Szent Rokus Korhaz
  • Fresenius Medical Care Egeszsegugyi Kft.
  • Eszak-Pesti Centrumkorhaz-Honvedkorhaz
  • Csongrad Megyei Egeszsegugyi Ellato Kozpont,Hodmezovasarhely
  • Keszthelyi Korhaz
  • Fresenius Medical Care Egeszsegugyi Kft.
  • Fresenius Medical Care Egeszsegugyi Kft.
  • Barzilai Medical Center | Nephrology & Hypertension Dept.
  • Lady Davis Carmel Medical Center
  • Health Corporation of Galilee Medical Center
  • Rabin Medical Center, HaSharon (Golda) Campus
  • Clalit Health Services Rabin Medical Center-Beilinson Campus
  • Poriya Medical Center | Nephrology and Hypertension Dept.
  • Shamir Medical Center (Assaf Harofeh)
  • A.O.U. di Bologna Policlinico S.Orsola Malpighi
  • A.O.U. di Parma
  • AUSL-IRCCS di Reggio Emilia
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • IRCCS Ospedale Policlinico San Martino
  • IRCCS Istituti Clinici Scientifici Maugeri SpA SB
  • A.O.U. Careggi
  • Ibaraki Seinan Medical Center Hospital
  • Tsuchiura Beryl Clinic
  • Ohishi Naika Clinic
  • Kikuchi Medical Clinic
  • Katta General Hospital
  • Nagaoka Red Cross Hospital
  • Saiyu Clinic
  • Takemura Medical Nephro Clinic
  • Futakotamagawaekimae clinic
  • Saint Hill Hospital
  • Akebono Clinic
  • Kyoto Station Takeda Dialysis Clinic
  • Akagaki Clinic
  • Yabuki Hospital
  • LUHS Kauno Hospital (Josvainiu str.)
  • Academisch Medisch Centrum (AMC)
  • Gelre Ziekenhuizen
  • Deventer Ziekenhuis
  • Albert Schweitzer Ziekenhuis, Dordwijk
  • Catharina Ziekenhuis
  • Maasstad Ziekenhuis | Neurology Department
  • Wojewodzki Szpital Zespolony
  • Stacja Dializ Olkusz
  • NZOZ Nowy Szpital w Swieciu Sp. z o.o.
  • Stacja Dializ W-wa Mangalia
  • Stacja Dializ Zyrardow
  • Eurodial Obidos (DaVita)
  • SPD - Amadora (Diaverum Amadora)
  • CHLO - Hospital Santa Cruz
  • Pluribus Dialise - Cascais (DaVita)
  • Pluribus Dialise - Sacavem (DaVita)
  • Caledial - Centro de Hemodialise de Gaia
  • Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department
  • Diaverum Aveiro
  • Eurodial Leiria (DaVita)
  • NephroCare APDP
  • Chelyabinsk Regional Clinical Hospital
  • LLC Dialysis center
  • LLC Fresenius medical care Kuban
  • LLC Dialysis center
  • City Clinical Hospital #1 Orenburg
  • Republican Hospital n.a. V.A. Baranov
  • Kupchinsky center for outpatient dialysis
  • LLC B. Brown Avitum Russland Clinics
  • City Hospital #31
  • LLC Yaroslavl dialysis center
  • Sverdlovsk Regional Clinical Hospital #1
  • Hospital Clínico Universitario de Santiago de Compostela
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Althaia, Xarxa Assistencial de Manresa
  • Corporació Sanitària Parc Taulí
  • Hospital Clinico Universitario San Carlos | Nefrologia
  • Hospital Clínico Universitario de Valencia
  • Hospital Universitario Dr. Peset
  • Hacettepe Universitesi Tip Fakultesi
  • Adnan Menderes Universitesi Tip fakultesi
  • Turk Bobrek Vakfi Memorial Hizmet Hastanesi
  • Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi
  • Erciyes Universitesi Tip Fakultesi
  • Kocaeli Universitesi Tip Fakultesi
  • Inonu Universitesi Tip Fakultesi
  • Brovarskaya multidisciplinary clinical hospital
  • Medical center LLC " Fresenius medical care Ukraine"
  • Dnepropetrovsk regional hospital n.a. I. I. Mechnikov
  • Regional Clinical Hospital - Ivano-Frankivsk
  • Kharkiv regional Clinical Centre of urology and nephrology
  • Kyiv City Center of Nephrology and Dialysis
  • State Institution "Institute of Nephrology" NAMS of Ukraine
  • Lutsk city clinical hospital
  • Mykolaiv Regional Clinical Hospital
  • Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
  • Transcarpatian Regional Clinical Hospital
  • Vinnitsa Regional Clinical Hospital im. N.I. Pirogov
  • Zaporizhzhia Regional Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

BAY1213790 low dose

Placebo low dose

BAY1213790 high dose

Placebo high dose

Arm Description

Participants will receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg until the end of the extension treatment period.

Placebo will be administered subcutaneously in the same manner as Osocimab.

Participants will receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg until the end of the extension treatment period.

Placebo will be administered subcutaneously in the same manner as Osocimab.

Outcomes

Primary Outcome Measures

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)
Cumulative incidence risk of the first Composite of MB and CRNMB (ISTH) at month 6 is reported in the table. Descriptive time to composite of MB and CRNMB Events is reported in statistical analysis. Descriptive time to composite of treatment emergent major and CRNMB events [in alignment with International Society on Thrombosis and Haemostatsis (ISTH) guidelines] analyses were performed. The cumulative incidence function for the event-of-interest together with the corresponding confidence interval were estimated for each treatment arm using Aalen-Johansen estimators. Cumulative incidence of events up to the day, inclusive.
Cumulative Incidence Risk of Composite of Moderate and Severe Adverse Events (AEs) and Serious Adverse Events (SAEs)
Cumulative incidence risk of composite of moderate and severe AEs and SAEs at month 6 is reported in the table. Descriptive time to the composite of Moderate and Severe AEs and SAEs is reported in statistical analysis. An AE was any untoward medical occurrence in a patient or clinical study participant, whether or not considered related to the study intervention.

Secondary Outcome Measures

Ratio of Activated Partial Thromboplastin Time (aPTT) at 6 Months Trough Levels Versus Baseline.
The aPTT at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation). aPTT was measured via the kaolin-trigger method (clotting assay).
Ratio of Factor XI (FXI) Activity at 6 Months Trough Levels Versus Baseline
The Factor XI (FXI) activity at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation). Factor XI activity was assessed with an aPTT-based coagulation test using FXI deficient plasma.

Full Information

First Posted
August 20, 2020
Last Updated
July 13, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT04523220
Brief Title
Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis
Acronym
CONVERT
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
December 28, 2021 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease, Prevention of Thromboembolic Events, Hemodialysis, Hemodiafiltration
Keywords
End-stage renal disease (ESRD), Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
704 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAY1213790 low dose
Arm Type
Experimental
Arm Description
Participants will receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg until the end of the extension treatment period.
Arm Title
Placebo low dose
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered subcutaneously in the same manner as Osocimab.
Arm Title
BAY1213790 high dose
Arm Type
Experimental
Arm Description
Participants will receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg until the end of the extension treatment period.
Arm Title
Placebo high dose
Arm Type
Experimental
Arm Description
Placebo will be administered subcutaneously in the same manner as Osocimab.
Intervention Type
Drug
Intervention Name(s)
BAY1213790 (Osocimab)
Intervention Description
Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous administration in the same manner as Osocimab.
Primary Outcome Measure Information:
Title
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)
Description
Cumulative incidence risk of the first Composite of MB and CRNMB (ISTH) at month 6 is reported in the table. Descriptive time to composite of MB and CRNMB Events is reported in statistical analysis. Descriptive time to composite of treatment emergent major and CRNMB events [in alignment with International Society on Thrombosis and Haemostatsis (ISTH) guidelines] analyses were performed. The cumulative incidence function for the event-of-interest together with the corresponding confidence interval were estimated for each treatment arm using Aalen-Johansen estimators. Cumulative incidence of events up to the day, inclusive.
Time Frame
From the first dose of study intervention up till 30 days after last study intervention in the main treatment period, up to 6 months
Title
Cumulative Incidence Risk of Composite of Moderate and Severe Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Cumulative incidence risk of composite of moderate and severe AEs and SAEs at month 6 is reported in the table. Descriptive time to the composite of Moderate and Severe AEs and SAEs is reported in statistical analysis. An AE was any untoward medical occurrence in a patient or clinical study participant, whether or not considered related to the study intervention.
Time Frame
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 Outcome Measure Information:
Title
Ratio of Activated Partial Thromboplastin Time (aPTT) at 6 Months Trough Levels Versus Baseline.
Description
The aPTT at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation). aPTT was measured via the kaolin-trigger method (clotting assay).
Time Frame
At 6 months (Visit 19 / Day 30 of the 6th month)
Title
Ratio of Factor XI (FXI) Activity at 6 Months Trough Levels Versus Baseline
Description
The Factor XI (FXI) activity at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation). Factor XI activity was assessed with an aPTT-based coagulation test using FXI deficient plasma.
Time Frame
At 6 months (Visit 19 / Day 30 of the 6th month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
North America Research Institute - Azusa
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Fresenius Kidney Care - Brawley
City
Brawley
State/Province
California
ZIP/Postal Code
92227
Country
United States
Facility Name
DaVita South Valley Dialysis
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Fresenius Kidney Care - La Mesa
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
East L.A. Dialysis Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Van Buren Dialysis Center
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Facility Name
Fresenius Kidney Care Kearny Mesa
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
FMC San Ysidro
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
Facility Name
Queen's Dialysis Unit
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
DaVita Greater Waterbury Dialysis
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
ARA Plantation Dialysis, LLC
City
Ellenton
State/Province
Florida
ZIP/Postal Code
34222
Country
United States
Facility Name
ARA Augusta
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Liberty Dialysis- Caldwell
City
Caldwell
State/Province
Idaho
ZIP/Postal Code
83605
Country
United States
Facility Name
Fresenius Kidney Care Evergreen Park
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Fresenius Kidney Care Baton Rouge Mancuso Lane
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Fresenius Kidney Care South Dialysis
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
ARA Holyoke Dialysis Center
City
Holyoke
State/Province
Massachusetts
ZIP/Postal Code
01040
Country
United States
Facility Name
Davita Hospital Hill Dialysis
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Renal Medicine Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Durham Nephrology Associates, Pa
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Waterloo Dialysis
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Fresenius North Austin Dialysis Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Fresenius Kidney Care - Mission Bend (FMCNA #3971)
City
Houston
State/Province
Texas
ZIP/Postal Code
77083
Country
United States
Facility Name
Fresenius Kidney Care Sugar Land
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Liberty Dialysis St. George
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
DaVita Butler Farm Dialysis
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Sydney Adventist Hospital
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Eastern Health Integrated Renal Service
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton Heights
ZIP/Postal Code
2305
Country
Australia
Facility Name
Klinikum Klagenfurt am Wörthersee
City
Klagenfurt
State/Province
Kärnten
ZIP/Postal Code
9020
Country
Austria
Facility Name
Privatklinik Wehrle-Diakonissen
City
Salzburg
ZIP/Postal Code
5026
Country
Austria
Facility Name
Klinik Landstraße - Krankenhaus Rudolfstiftung
City
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
Universitätsklinikum AKH Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Epicura
City
Baudour
ZIP/Postal Code
7331
Country
Belgium
Facility Name
Imeldaziekenhuis - St-Elisabethkliniek
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ St-Lucas Campus St-Lucas
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liege | CHR Citadel - Department of Nephrology
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Nikolaas Campus Sint-Niklaas
City
Sint-niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
MHAT Sveti Ivan Rilski 2003
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
MHAT Haskovo
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Facility Name
UMHAT Kanev AD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
MHAT Shumen AD
City
Shumen
ZIP/Postal Code
9700
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Hristo Botev AD
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Krajska Nemocnice Liberec
City
Liberec
ZIP/Postal Code
460 63
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Privamed s.r.o.
City
Plzen
ZIP/Postal Code
323 33
Country
Czechia
Facility Name
Fresenius Nephro Care s.r.o. - Sokolov
City
Sokolov
ZIP/Postal Code
356 01
Country
Czechia
Facility Name
General Hospital of Arta
City
Arta
ZIP/Postal Code
47100
Country
Greece
Facility Name
HIPPOKRATION General Hospital of Athens
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
General Hospital of Athens LAIKO
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Ioannina University General Hospital
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Hippokration General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
General Hospital of Thessaloniki Papageorgiou
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
Facility Name
Bajai Szent Rokus Korhaz
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Fresenius Medical Care Egeszsegugyi Kft.
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Eszak-Pesti Centrumkorhaz-Honvedkorhaz
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Csongrad Megyei Egeszsegugyi Ellato Kozpont,Hodmezovasarhely
City
Hodmezovasarhely
ZIP/Postal Code
6800
Country
Hungary
Facility Name
Keszthelyi Korhaz
City
Keszthely
ZIP/Postal Code
8360
Country
Hungary
Facility Name
Fresenius Medical Care Egeszsegugyi Kft.
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Fresenius Medical Care Egeszsegugyi Kft.
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Barzilai Medical Center | Nephrology & Hypertension Dept.
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Health Corporation of Galilee Medical Center
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Facility Name
Rabin Medical Center, HaSharon (Golda) Campus
City
Petach Tikva
ZIP/Postal Code
4937211
Country
Israel
Facility Name
Clalit Health Services Rabin Medical Center-Beilinson Campus
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Poriya Medical Center | Nephrology and Hypertension Dept.
City
Tiberius
ZIP/Postal Code
1528001
Country
Israel
Facility Name
Shamir Medical Center (Assaf Harofeh)
City
Zerifin
ZIP/Postal Code
7030000
Country
Israel
Facility Name
A.O.U. di Bologna Policlinico S.Orsola Malpighi
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O.U. di Parma
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43126
Country
Italy
Facility Name
AUSL-IRCCS di Reggio Emilia
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42123
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
IRCCS Ospedale Policlinico San Martino
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
IRCCS Istituti Clinici Scientifici Maugeri SpA SB
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
A.O.U. Careggi
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Ibaraki Seinan Medical Center Hospital
City
Sashima-gun
State/Province
Ibaraki
ZIP/Postal Code
306-0433
Country
Japan
Facility Name
Tsuchiura Beryl Clinic
City
Tsuchiura
State/Province
Ibaraki
ZIP/Postal Code
300-0062
Country
Japan
Facility Name
Ohishi Naika Clinic
City
Tsuchiura
State/Province
Ibaraki
ZIP/Postal Code
300-0835
Country
Japan
Facility Name
Kikuchi Medical Clinic
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-0861
Country
Japan
Facility Name
Katta General Hospital
City
Shiraishi
State/Province
Miyagi
ZIP/Postal Code
989-0231
Country
Japan
Facility Name
Nagaoka Red Cross Hospital
City
Nagaoka
State/Province
Niigata
ZIP/Postal Code
940-2085
Country
Japan
Facility Name
Saiyu Clinic
City
Koshigaya
State/Province
Saitama
ZIP/Postal Code
343-0823
Country
Japan
Facility Name
Takemura Medical Nephro Clinic
City
Kanuma
State/Province
Tochigi
ZIP/Postal Code
322-0029
Country
Japan
Facility Name
Futakotamagawaekimae clinic
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
158-0094
Country
Japan
Facility Name
Saint Hill Hospital
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-0155
Country
Japan
Facility Name
Akebono Clinic
City
Kumamoto
ZIP/Postal Code
861-4112
Country
Japan
Facility Name
Kyoto Station Takeda Dialysis Clinic
City
Kyoto
ZIP/Postal Code
600-8216
Country
Japan
Facility Name
Akagaki Clinic
City
Osaka
ZIP/Postal Code
543-0052
Country
Japan
Facility Name
Yabuki Hospital
City
Yamagata
ZIP/Postal Code
990-0885
Country
Japan
Facility Name
LUHS Kauno Hospital (Josvainiu str.)
City
Kaunas
ZIP/Postal Code
LT-47116
Country
Lithuania
Facility Name
Academisch Medisch Centrum (AMC)
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Gelre Ziekenhuizen
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
Facility Name
Deventer Ziekenhuis
City
Deventer
ZIP/Postal Code
7416 SE
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis, Dordwijk
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Maasstad Ziekenhuis | Neurology Department
City
Rotterdam
ZIP/Postal Code
3079DZ
Country
Netherlands
Facility Name
Wojewodzki Szpital Zespolony
City
Kielce
ZIP/Postal Code
25-736
Country
Poland
Facility Name
Stacja Dializ Olkusz
City
Olkusz
ZIP/Postal Code
32-300
Country
Poland
Facility Name
NZOZ Nowy Szpital w Swieciu Sp. z o.o.
City
Swiecie
ZIP/Postal Code
86-100
Country
Poland
Facility Name
Stacja Dializ W-wa Mangalia
City
Warszawa
ZIP/Postal Code
02-758
Country
Poland
Facility Name
Stacja Dializ Zyrardow
City
Zyrardow
ZIP/Postal Code
96-300
Country
Poland
Facility Name
Eurodial Obidos (DaVita)
City
Gaeiras - Obidos
State/Province
Leiria
ZIP/Postal Code
2510-702
Country
Portugal
Facility Name
SPD - Amadora (Diaverum Amadora)
City
Amadora
State/Province
Lisboa
ZIP/Postal Code
2700-001
Country
Portugal
Facility Name
CHLO - Hospital Santa Cruz
City
Carnaxide
State/Province
Lisboa
ZIP/Postal Code
2795-53
Country
Portugal
Facility Name
Pluribus Dialise - Cascais (DaVita)
City
Cascais
State/Province
Lisboa
ZIP/Postal Code
2750-663
Country
Portugal
Facility Name
Pluribus Dialise - Sacavem (DaVita)
City
Sacavem
State/Province
Lisboa
ZIP/Postal Code
2685-005
Country
Portugal
Facility Name
Caledial - Centro de Hemodialise de Gaia
City
Canelas
State/Province
Porto
ZIP/Postal Code
4410-313
Country
Portugal
Facility Name
Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department
City
Torres Novas
State/Province
Santarém
ZIP/Postal Code
2350-754
Country
Portugal
Facility Name
Diaverum Aveiro
City
Aveiro
ZIP/Postal Code
3800-266
Country
Portugal
Facility Name
Eurodial Leiria (DaVita)
City
Leiria
ZIP/Postal Code
2400-441
Country
Portugal
Facility Name
NephroCare APDP
City
Lisboa
ZIP/Postal Code
1250-191
Country
Portugal
Facility Name
Chelyabinsk Regional Clinical Hospital
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Facility Name
LLC Dialysis center
City
Kolomna
ZIP/Postal Code
140402
Country
Russian Federation
Facility Name
LLC Fresenius medical care Kuban
City
Krasnodar
ZIP/Postal Code
350029
Country
Russian Federation
Facility Name
LLC Dialysis center
City
Mytishchi
ZIP/Postal Code
141007
Country
Russian Federation
Facility Name
City Clinical Hospital #1 Orenburg
City
Orenburg
ZIP/Postal Code
460040
Country
Russian Federation
Facility Name
Republican Hospital n.a. V.A. Baranov
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Kupchinsky center for outpatient dialysis
City
St. Petersburg
ZIP/Postal Code
192102
Country
Russian Federation
Facility Name
LLC B. Brown Avitum Russland Clinics
City
St. Petersburg
ZIP/Postal Code
193318
Country
Russian Federation
Facility Name
City Hospital #31
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
LLC Yaroslavl dialysis center
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Sverdlovsk Regional Clinical Hospital #1
City
Yekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Hospital Clínico Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Althaia, Xarxa Assistencial de Manresa
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
Facility Name
Corporació Sanitària Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos | Nefrologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hacettepe Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Adnan Menderes Universitesi Tip fakultesi
City
Aydin
ZIP/Postal Code
09100
Country
Turkey
Facility Name
Turk Bobrek Vakfi Memorial Hizmet Hastanesi
City
Istanbul
ZIP/Postal Code
34180
Country
Turkey
Facility Name
Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi
City
Istanbul
ZIP/Postal Code
34418
Country
Turkey
Facility Name
Erciyes Universitesi Tip Fakultesi
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Kocaeli Universitesi Tip Fakultesi
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Inonu Universitesi Tip Fakultesi
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Brovarskaya multidisciplinary clinical hospital
City
Brovary
ZIP/Postal Code
07400
Country
Ukraine
Facility Name
Medical center LLC " Fresenius medical care Ukraine"
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Dnepropetrovsk regional hospital n.a. I. I. Mechnikov
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Regional Clinical Hospital - Ivano-Frankivsk
City
Ivano-Frankivsk
ZIP/Postal Code
76000
Country
Ukraine
Facility Name
Kharkiv regional Clinical Centre of urology and nephrology
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Kyiv City Center of Nephrology and Dialysis
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
Facility Name
State Institution "Institute of Nephrology" NAMS of Ukraine
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Lutsk city clinical hospital
City
Lutsk
ZIP/Postal Code
43024
Country
Ukraine
Facility Name
Mykolaiv Regional Clinical Hospital
City
Mykolaiv
ZIP/Postal Code
54058
Country
Ukraine
Facility Name
Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Transcarpatian Regional Clinical Hospital
City
Uzhgorod
ZIP/Postal Code
88018
Country
Ukraine
Facility Name
Vinnitsa Regional Clinical Hospital im. N.I. Pirogov
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Zaporizhzhia Regional Clinical Hospital
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no current plans to share data.
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Learn more about this trial

Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis

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