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

NCT ID: NCT04523220

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 704 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-28
• Study Completion Date: 2022-05-30

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.

Conditions

End-stage Renal Disease; Prevention of Thromboembolic Events; Hemodialysis; Hemodiafiltration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

BAY1213790 low dose

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.

Group Type: EXPERIMENTAL

BAY1213790 (Osocimab)

Intervention Type: DRUG

Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.

Placebo low dose

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subcutaneous administration in the same manner as Osocimab.

BAY1213790 high dose

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.

Group Type: EXPERIMENTAL

BAY1213790 (Osocimab)

Intervention Type: DRUG

Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.

Placebo high dose

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Subcutaneous administration in the same manner as Osocimab.

Interventions

BAY1213790 (Osocimab)

Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.

Intervention Type: DRUG

Placebo

Subcutaneous administration in the same manner as Osocimab.

Intervention Type: 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

North America Research Institute - Azusa

Azusa, California, United States

Fresenius Kidney Care - Brawley

Brawley, California, United States

DaVita South Valley Dialysis

Encino, California, United States

Fresenius Kidney Care - La Mesa

La Mesa, California, United States

East L.A. Dialysis Center

Los Angeles, California, United States

Van Buren Dialysis Center

Riverside, California, United States

Fresenius Kidney Care Kearny Mesa

San Diego, California, United States

FMC San Ysidro

San Diego, California, United States

Queen's Dialysis Unit

West Covina, California, United States

DaVita Greater Waterbury Dialysis

Waterbury, Connecticut, United States

ARA Plantation Dialysis, LLC

Ellenton, Florida, United States

ARA Augusta

Augusta, Georgia, United States

Liberty Dialysis- Caldwell

Caldwell, Idaho, United States

Fresenius Kidney Care Evergreen Park

Evergreen Park, Illinois, United States

Fresenius Kidney Care Baton Rouge Mancuso Lane

Baton Rouge, Louisiana, United States

Fresenius Kidney Care South Dialysis

Shreveport, Louisiana, United States

ARA Holyoke Dialysis Center

Holyoke, Massachusetts, United States

Davita Hospital Hill Dialysis

Kansas City, Missouri, United States

Renal Medicine Associates

Albuquerque, New Mexico, United States

Durham Nephrology Associates, Pa

Durham, North Carolina, United States

Waterloo Dialysis

Austin, Texas, United States

Fresenius North Austin Dialysis Center

Austin, Texas, United States

Fresenius Kidney Care - Mission Bend (FMCNA #3971)

Houston, Texas, United States

Fresenius Kidney Care Sugar Land

Sugar Land, Texas, United States

Liberty Dialysis St. George

St. George, Utah, United States

DaVita Butler Farm Dialysis

Hampton, Virginia, United States

Sydney Adventist Hospital

Wahroonga, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Eastern Health Integrated Renal Service

Box Hill, , Australia

John Hunter Hospital

New Lambton Heights, , Australia

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Carinthia, Austria

Privatklinik Wehrle-Diakonissen

Salzburg, , Austria

Klinik Landstraße - Krankenhaus Rudolfstiftung

Vienna, , Austria

Universitätsklinikum AKH Wien

Vienna, , Austria

Epicura

Baudour, , Belgium

Imeldaziekenhuis - St-Elisabethkliniek

Bonheiden, , Belgium

AZ St-Lucas Campus St-Lucas

Ghent, , Belgium

UZ Leuven Gasthuisberg

Leuven, , Belgium

CHU de Liege | CHR Citadel - Department of Nephrology

Liège, , Belgium

AZ Nikolaas Campus Sint-Niklaas

Sint-Niklaas, , Belgium

MHAT Sveti Ivan Rilski 2003

Dupnitsa, , Bulgaria

MHAT Haskovo

Haskovo, , Bulgaria

UMHAT Kanev AD

Rousse, , Bulgaria

MHAT Shumen AD

Shumen, , Bulgaria

Multiprofile Hospital for Active Treatment Hristo Botev AD

Vratsa, , Bulgaria

Krajska Nemocnice Liberec

Liberec, , Czechia

Fakultni nemocnice Ostrava

Ostrava, , Czechia

Privamed s.r.o.

Pilsen, , Czechia

Fresenius Nephro Care s.r.o. - Sokolov

Sokolov, , Czechia

General Hospital of Arta

Arta, , Greece

HIPPOKRATION General Hospital of Athens

Athens, , Greece

General Hospital of Athens LAIKO

Athens, , Greece

Ioannina University General Hospital

Ioannina, , Greece

University General Hospital of Larissa

Larissa, , Greece

Hippokration General Hospital of Thessaloniki

Thessaloniki, , Greece

General Hospital of Thessaloniki Papageorgiou

Thessaloniki, , Greece

Bajai Szent Rokus Korhaz

Baja, , Hungary

Fresenius Medical Care Egeszsegugyi Kft.

Budapest, , Hungary

Eszak-Pesti Centrumkorhaz-Honvedkorhaz

Budapest, , Hungary

Csongrad Megyei Egeszsegugyi Ellato Kozpont,Hodmezovasarhely

Hódmezővásárhely, , Hungary

Keszthelyi Korhaz

Keszthely, , Hungary

Fresenius Medical Care Egeszsegugyi Kft.

Miskolc, , Hungary

Fresenius Medical Care Egeszsegugyi Kft.

Pécs, , Hungary

Barzilai Medical Center | Nephrology & Hypertension Dept.

Ashkelon, , Israel

Lady Davis Carmel Medical Center

Haifa, , Israel

Health Corporation of Galilee Medical Center

Nahariya, , Israel

Rabin Medical Center, HaSharon (Golda) Campus

Petah Tikva, , Israel

Clalit Health Services Rabin Medical Center-Beilinson Campus

Petah Tikva, , Israel

Poriya Medical Center | Nephrology and Hypertension Dept.

Tiberius, , Israel

Shamir Medical Center (Assaf Harofeh)

Ẕerifin, , Israel

A.O.U. di Bologna Policlinico S.Orsola Malpighi

Bologna, Emilia-Romagna, Italy

A.O.U. di Parma

Parma, Emilia-Romagna, Italy

AUSL-IRCCS di Reggio Emilia

Reggio Emilia, Emilia-Romagna, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, Italy

IRCCS Ospedale Policlinico San Martino

Genoa, Liguria, Italy

IRCCS Istituti Clinici Scientifici Maugeri SpA SB

Pavia, Lombardy, Italy

A.O.U. Careggi

Florence, Tuscany, Italy

Ibaraki Seinan Medical Center Hospital

Sashima-gun, Ibaraki, Japan

Tsuchiura Beryl Clinic

Tsuchiura, Ibaraki, Japan

Ohishi Naika Clinic

Tsuchiura, Ibaraki, Japan

Kikuchi Medical Clinic

Tsukuba, Ibaraki, Japan

Katta General Hospital

Shiraishi, Miyagi, Japan

Nagaoka Red Cross Hospital

Nagaoka, Niigata, Japan

Saiyu Clinic

Koshigaya, Saitama, Japan

Takemura Medical Nephro Clinic

Kanuma, Tochigi, Japan

Futakotamagawaekimae clinic

Setagaya-ku, Tokyo, Japan

Saint Hill Hospital

Ube, Yamaguchi, Japan

Akebono Clinic

Kumamoto, , Japan

Kyoto Station Takeda Dialysis Clinic

Kyoto, , Japan

Akagaki Clinic

Osaka, , Japan

Yabuki Hospital

Yamagata, , Japan

LUHS Kauno Hospital (Josvainiu str.)

Kaunas, , Lithuania

Academisch Medisch Centrum (AMC)

Amsterdam, , Netherlands

Gelre Ziekenhuizen

Apeldoorn, , Netherlands

Deventer Ziekenhuis

Deventer, , Netherlands

Albert Schweitzer Ziekenhuis, Dordwijk

Dordrecht, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

Maasstad Ziekenhuis | Neurology Department

Rotterdam, , Netherlands

NZOZ Nowy Szpital w Swieciu Sp. z o.o.

Gmina Świecie, , Poland

Wojewodzki Szpital Zespolony

Kielce, , Poland

Stacja Dializ Olkusz

Olkusz, , Poland

Stacja Dializ W-wa Mangalia

Warsaw, , Poland

Stacja Dializ Zyrardow

Żyrardów, , Poland

Eurodial Obidos (DaVita)

Gaeiras - Obidos, Leiria District, Portugal

SPD - Amadora (Diaverum Amadora)

Amadora, Lisbon District, Portugal

CHLO - Hospital Santa Cruz

Carnaxide, Lisbon District, Portugal

Pluribus Dialise - Cascais (DaVita)

Cascais, Lisbon District, Portugal

Pluribus Dialise - Sacavem (DaVita)

Sacavém, Lisbon District, Portugal

Caledial - Centro de Hemodialise de Gaia

Canelas, Porto District, Portugal

Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department

Torres Novas, Santarém District, Portugal

Diaverum Aveiro

Aveiro, , Portugal

Eurodial Leiria (DaVita)

Leiria, , Portugal

NephroCare APDP

Lisbon, , Portugal

Chelyabinsk Regional Clinical Hospital

Chelyabinsk, , Russia

LLC Dialysis center

Kolomna, , Russia

LLC Fresenius medical care Kuban

Krasnodar, , Russia

LLC Dialysis center

Mytishchi, , Russia

City Clinical Hospital #1 Orenburg

Orenburg, , Russia

Republican Hospital n.a. V.A. Baranov

Petrozavodsk, , Russia

Kupchinsky center for outpatient dialysis

Saint Petersburg, , Russia

LLC B. Brown Avitum Russland Clinics

Saint Petersburg, , Russia

City Hospital #31

Saint Petersburg, , Russia

LLC Yaroslavl dialysis center

Yaroslavl, , Russia

Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, , Russia

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Althaia, Xarxa Assistencial de Manresa

Manresa, Barcelona, Spain

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Hospital Clinico Universitario San Carlos | Nefrologia

Madrid, , Spain

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Hospital Universitario Dr. Peset

Valencia, , Spain

Hacettepe Universitesi Tip Fakultesi

Ankara, , Turkey (Türkiye)

Adnan Menderes Universitesi Tip fakultesi

Aydin, , Turkey (Türkiye)

Turk Bobrek Vakfi Memorial Hizmet Hastanesi

Istanbul, , Turkey (Türkiye)

Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi

Istanbul, , Turkey (Türkiye)

Erciyes Universitesi Tip Fakultesi

Kayseri, , Turkey (Türkiye)

Kocaeli Universitesi Tip Fakultesi

Kocaeli, , Turkey (Türkiye)

Inonu Universitesi Tip Fakultesi

Malatya, , Turkey (Türkiye)

Brovarskaya multidisciplinary clinical hospital

Brovary, , Ukraine

Medical center LLC " Fresenius medical care Ukraine"

Cherkasy, , Ukraine

Dnepropetrovsk regional hospital n.a. I. I. Mechnikov

Dnipro, , Ukraine

Regional Clinical Hospital - Ivano-Frankivsk

Ivano-Frankivsk, , Ukraine

Kharkiv regional Clinical Centre of urology and nephrology

Kharkiv, , Ukraine

Kyiv City Center of Nephrology and Dialysis

Kyiv, , Ukraine

State Institution "Institute of Nephrology" NAMS of Ukraine

Kyiv, , Ukraine

Lutsk city clinical hospital

Lutsk, , Ukraine

Mykolaiv Regional Clinical Hospital

Mykolaiv, , Ukraine

Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi

Poltava, , Ukraine

Transcarpatian Regional Clinical Hospital

Uzhhorod, , Ukraine

Vinnitsa Regional Clinical Hospital im. N.I. Pirogov

Vinnytsia, , Ukraine

Zaporizhzhia Regional Clinical Hospital

Zaporizhzhya, , Ukraine

Countries

United States; Australia; Austria; Belgium; Bulgaria; Czechia; Greece; Hungary; Israel; Italy; Japan; Lithuania; Netherlands; Poland; Portugal; Russia; Spain; Turkey (Türkiye); Ukraine

References

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.

Reference Type: DERIVED

PMID: 38365952 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

2019-003957-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20115

Identifier Type: -

Identifier Source: org_study_id