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
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
2 other identifiers
interventional
704
18 countries
147
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2020
147 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2020
CompletedFirst Posted
Study publicly available on registry
August 21, 2020
CompletedStudy Start
First participant enrolled
August 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedResults Posted
Study results publicly available
July 21, 2023
CompletedJuly 21, 2023
July 1, 2023
1.3 years
August 20, 2020
May 5, 2023
July 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
From the first dose of study intervention up till 30 days after last study intervention in the main treatment period, up to 6 months
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.
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 (2)
Ratio of Activated Partial Thromboplastin Time (aPTT) at 6 Months Trough Levels Versus Baseline.
At 6 months (Visit 19 / Day 30 of the 6th month)
Ratio of Factor XI (FXI) Activity at 6 Months Trough Levels Versus Baseline
At 6 months (Visit 19 / Day 30 of the 6th month)
Study Arms (4)
BAY1213790 low dose
EXPERIMENTALParticipants 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 low dose
PLACEBO COMPARATORPlacebo will be administered subcutaneously in the same manner as Osocimab.
BAY1213790 high dose
EXPERIMENTALParticipants 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 high dose
EXPERIMENTALPlacebo will be administered subcutaneously in the same manner as Osocimab.
Interventions
Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.
Subcutaneous administration in the same manner as Osocimab.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (151)
North America Research Institute - Azusa
Azusa, California, 91702, United States
Fresenius Kidney Care - Brawley
Brawley, California, 92227, United States
DaVita South Valley Dialysis
Encino, California, 91316, United States
Fresenius Kidney Care - La Mesa
La Mesa, California, 91942, United States
East L.A. Dialysis Center
Los Angeles, California, 90022, United States
Van Buren Dialysis Center
Riverside, California, 92503, United States
Fresenius Kidney Care Kearny Mesa
San Diego, California, 92111, United States
FMC San Ysidro
San Diego, California, 92154, United States
Queen's Dialysis Unit
West Covina, California, 91790, United States
DaVita Greater Waterbury Dialysis
Waterbury, Connecticut, 06708, United States
ARA Plantation Dialysis, LLC
Ellenton, Florida, 34222, United States
ARA Augusta
Augusta, Georgia, 30901, United States
Liberty Dialysis- Caldwell
Caldwell, Idaho, 83605, United States
Fresenius Kidney Care Evergreen Park
Evergreen Park, Illinois, 60805, United States
Fresenius Kidney Care Baton Rouge Mancuso Lane
Baton Rouge, Louisiana, 70808, United States
Fresenius Kidney Care South Dialysis
Shreveport, Louisiana, 71106, United States
ARA Holyoke Dialysis Center
Holyoke, Massachusetts, 01040, United States
Davita Hospital Hill Dialysis
Kansas City, Missouri, 64108, United States
Renal Medicine Associates
Albuquerque, New Mexico, 87109, United States
Durham Nephrology Associates, Pa
Durham, North Carolina, 27704, United States
Waterloo Dialysis
Austin, Texas, 78756, United States
Fresenius North Austin Dialysis Center
Austin, Texas, 78758, United States
Fresenius Kidney Care - Mission Bend (FMCNA #3971)
Houston, Texas, 77083, United States
Fresenius Kidney Care Sugar Land
Sugar Land, Texas, 77479, United States
Liberty Dialysis St. George
St. George, Utah, 84790, United States
DaVita Butler Farm Dialysis
Hampton, Virginia, 23666, United States
Sydney Adventist Hospital
Wahroonga, New South Wales, 2076, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Eastern Health Integrated Renal Service
Box Hill, 3128, Australia
John Hunter Hospital
New Lambton Heights, 2305, Australia
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Carinthia, 9020, Austria
Privatklinik Wehrle-Diakonissen
Salzburg, 5026, Austria
Klinik Landstraße - Krankenhaus Rudolfstiftung
Vienna, 1030, Austria
Universitätsklinikum AKH Wien
Vienna, 1090, Austria
Epicura
Baudour, 7331, Belgium
Imeldaziekenhuis - St-Elisabethkliniek
Bonheiden, 2820, Belgium
AZ St-Lucas Campus St-Lucas
Ghent, 9000, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
CHU de Liege | CHR Citadel - Department of Nephrology
Liège, 4000, Belgium
AZ Nikolaas Campus Sint-Niklaas
Sint-Niklaas, 9100, Belgium
MHAT Sveti Ivan Rilski 2003
Dupnitsa, 2600, Bulgaria
MHAT Haskovo
Haskovo, 6300, Bulgaria
UMHAT Kanev AD
Rousse, 7002, Bulgaria
MHAT Shumen AD
Shumen, 9700, Bulgaria
Multiprofile Hospital for Active Treatment Hristo Botev AD
Vratsa, 3000, Bulgaria
Krajska Nemocnice Liberec
Liberec, 460 63, Czechia
Fakultni nemocnice Ostrava
Ostrava, 708 52, Czechia
Privamed s.r.o.
Pilsen, 323 33, Czechia
Fresenius Nephro Care s.r.o. - Sokolov
Sokolov, 356 01, Czechia
General Hospital of Arta
Arta, 47100, Greece
HIPPOKRATION General Hospital of Athens
Athens, 115 27, Greece
General Hospital of Athens LAIKO
Athens, 11527, Greece
Ioannina University General Hospital
Ioannina, 45500, Greece
University General Hospital of Larissa
Larissa, 41110, Greece
Hippokration General Hospital of Thessaloniki
Thessaloniki, 54642, Greece
General Hospital of Thessaloniki Papageorgiou
Thessaloniki, 56403, Greece
Bajai Szent Rokus Korhaz
Baja, 6500, Hungary
Fresenius Medical Care Egeszsegugyi Kft.
Budapest, 1083, Hungary
Eszak-Pesti Centrumkorhaz-Honvedkorhaz
Budapest, 1134, Hungary
Csongrad Megyei Egeszsegugyi Ellato Kozpont,Hodmezovasarhely
Hódmezővásárhely, 6800, Hungary
Keszthelyi Korhaz
Keszthely, 8360, Hungary
Fresenius Medical Care Egeszsegugyi Kft.
Miskolc, 3526, Hungary
Fresenius Medical Care Egeszsegugyi Kft.
Pécs, 7624, Hungary
Barzilai Medical Center | Nephrology & Hypertension Dept.
Ashkelon, 7830604, Israel
Lady Davis Carmel Medical Center
Haifa, 3436212, Israel
Health Corporation of Galilee Medical Center
Nahariya, 2210001, Israel
Rabin Medical Center, HaSharon (Golda) Campus
Petah Tikva, 4937211, Israel
Clalit Health Services Rabin Medical Center-Beilinson Campus
Petah Tikva, 4941492, Israel
Poriya Medical Center | Nephrology and Hypertension Dept.
Tiberius, 1528001, Israel
Shamir Medical Center (Assaf Harofeh)
Ẕerifin, 7030000, Israel
A.O.U. di Bologna Policlinico S.Orsola Malpighi
Bologna, Emilia-Romagna, 40138, Italy
A.O.U. di Parma
Parma, Emilia-Romagna, 43126, Italy
AUSL-IRCCS di Reggio Emilia
Reggio Emilia, Emilia-Romagna, 42123, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168, Italy
IRCCS Ospedale Policlinico San Martino
Genoa, Liguria, 16132, Italy
IRCCS Istituti Clinici Scientifici Maugeri SpA SB
Pavia, Lombardy, 27100, Italy
A.O.U. Careggi
Florence, Tuscany, 50134, Italy
Ibaraki Seinan Medical Center Hospital
Sashima-gun, Ibaraki, 306-0433, Japan
Tsuchiura Beryl Clinic
Tsuchiura, Ibaraki, 300-0062, Japan
Ohishi Naika Clinic
Tsuchiura, Ibaraki, 300-0835, Japan
Kikuchi Medical Clinic
Tsukuba, Ibaraki, 305-0861, Japan
Katta General Hospital
Shiraishi, Miyagi, 989-0231, Japan
Nagaoka Red Cross Hospital
Nagaoka, Niigata, 940-2085, Japan
Saiyu Clinic
Koshigaya, Saitama, 343-0823, Japan
Takemura Medical Nephro Clinic
Kanuma, Tochigi, 322-0029, Japan
Futakotamagawaekimae clinic
Setagaya-ku, Tokyo, 158-0094, Japan
Saint Hill Hospital
Ube, Yamaguchi, 755-0155, Japan
Akebono Clinic
Kumamoto, 861-4112, Japan
Kyoto Station Takeda Dialysis Clinic
Kyoto, 600-8216, Japan
Akagaki Clinic
Osaka, 543-0052, Japan
Yabuki Hospital
Yamagata, 990-0885, Japan
LUHS Kauno Hospital (Josvainiu str.)
Kaunas, LT-47116, Lithuania
Academisch Medisch Centrum (AMC)
Amsterdam, 1105 AZ, Netherlands
Gelre Ziekenhuizen
Apeldoorn, 7334 DZ, Netherlands
Deventer Ziekenhuis
Deventer, 7416 SE, Netherlands
Albert Schweitzer Ziekenhuis, Dordwijk
Dordrecht, 3318 AT, Netherlands
Catharina Ziekenhuis
Eindhoven, 5623 EJ, Netherlands
Maasstad Ziekenhuis | Neurology Department
Rotterdam, 3079DZ, Netherlands
NZOZ Nowy Szpital w Swieciu Sp. z o.o.
Gmina Świecie, 86-100, Poland
Wojewodzki Szpital Zespolony
Kielce, 25-736, Poland
Stacja Dializ Olkusz
Olkusz, 32-300, Poland
Stacja Dializ W-wa Mangalia
Warsaw, 02-758, Poland
Stacja Dializ Zyrardow
Żyrardów, 96-300, Poland
Eurodial Obidos (DaVita)
Gaeiras - Obidos, Leiria District, 2510-702, Portugal
SPD - Amadora (Diaverum Amadora)
Amadora, Lisbon District, 2700-001, Portugal
CHLO - Hospital Santa Cruz
Carnaxide, Lisbon District, 2795-53, Portugal
Pluribus Dialise - Cascais (DaVita)
Cascais, Lisbon District, 2750-663, Portugal
Pluribus Dialise - Sacavem (DaVita)
Sacavém, Lisbon District, 2685-005, Portugal
Caledial - Centro de Hemodialise de Gaia
Canelas, Porto District, 4410-313, Portugal
Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department
Torres Novas, Santarém District, 2350-754, Portugal
Diaverum Aveiro
Aveiro, 3800-266, Portugal
Eurodial Leiria (DaVita)
Leiria, 2400-441, Portugal
NephroCare APDP
Lisbon, 1250-191, Portugal
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, 454076, Russia
LLC Dialysis center
Kolomna, 140402, Russia
LLC Fresenius medical care Kuban
Krasnodar, 350029, Russia
LLC Dialysis center
Mytishchi, 141007, Russia
City Clinical Hospital #1 Orenburg
Orenburg, 460040, Russia
Republican Hospital n.a. V.A. Baranov
Petrozavodsk, 185019, Russia
Kupchinsky center for outpatient dialysis
Saint Petersburg, 192102, Russia
LLC B. Brown Avitum Russland Clinics
Saint Petersburg, 193318, Russia
City Hospital #31
Saint Petersburg, 197110, Russia
LLC Yaroslavl dialysis center
Yaroslavl, 150062, Russia
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, 620102, Russia
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, 15706, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Althaia, Xarxa Assistencial de Manresa
Manresa, Barcelona, 08243, Spain
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, 08208, Spain
Hospital Clinico Universitario San Carlos | Nefrologia
Madrid, 28040, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitario Dr. Peset
Valencia, 46017, Spain
Hacettepe Universitesi Tip Fakultesi
Ankara, 06230, Turkey (Türkiye)
Adnan Menderes Universitesi Tip fakultesi
Aydin, 09100, Turkey (Türkiye)
Turk Bobrek Vakfi Memorial Hizmet Hastanesi
Istanbul, 34180, Turkey (Türkiye)
Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi
Istanbul, 34418, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi
Kayseri, 38039, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380, Turkey (Türkiye)
Inonu Universitesi Tip Fakultesi
Malatya, 44280, Turkey (Türkiye)
Brovarskaya multidisciplinary clinical hospital
Brovary, 07400, Ukraine
Medical center LLC " Fresenius medical care Ukraine"
Cherkasy, 18009, Ukraine
Dnepropetrovsk regional hospital n.a. I. I. Mechnikov
Dnipro, 49005, Ukraine
Regional Clinical Hospital - Ivano-Frankivsk
Ivano-Frankivsk, 76000, Ukraine
Kharkiv regional Clinical Centre of urology and nephrology
Kharkiv, 61037, Ukraine
Kyiv City Center of Nephrology and Dialysis
Kyiv, 02660, Ukraine
State Institution "Institute of Nephrology" NAMS of Ukraine
Kyiv, 04050, Ukraine
Lutsk city clinical hospital
Lutsk, 43024, Ukraine
Mykolaiv Regional Clinical Hospital
Mykolaiv, 54058, Ukraine
Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
Poltava, 36011, Ukraine
Transcarpatian Regional Clinical Hospital
Uzhhorod, 88018, Ukraine
Vinnitsa Regional Clinical Hospital im. N.I. Pirogov
Vinnytsia, 21018, Ukraine
Zaporizhzhia Regional Clinical Hospital
Zaporizhzhya, 69600, Ukraine
Related Publications (1)
Weitz JI, Tanko LB, Floege J, Fox KAA, Bhatt DL, Thadhani R, Hung J, Pap AF, Kubitza D, Winkelmayer WC; CONVERT Investigators. Anticoagulation with osocimab in patients with kidney failure undergoing hemodialysis: a randomized phase 2 trial. Nat Med. 2024 Feb;30(2):435-442. doi: 10.1038/s41591-023-02794-7. Epub 2024 Feb 16.
PMID: 38365952DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer AG
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2020
First Posted
August 21, 2020
Study Start
August 28, 2020
Primary Completion
December 28, 2021
Study Completion
May 30, 2022
Last Updated
July 21, 2023
Results First Posted
July 21, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share
There are no current plans to share data.