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

Hemodialysis Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04523220
• Other study ID #: 20115
• Secondary ID: 2019-003957-27
• Status: Completed
• Phase: Phase 2
• Start date: August 28, 2020
• Est. completion date: May 30, 2022

Study information

• Verified date: July 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 704
• Est. completion date: May 30, 2022
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Hemodiafiltration
• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic
• Prevention of Thromboembolic Events
• Thromboembolism

Intervention

Drug:
• BAY1213790 (Osocimab)
Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.
• Placebo
Subcutaneous administration in the same manner as Osocimab.

Locations

Country	Name	City	State
Australia	Eastern Health Integrated Renal Service	Box Hill
Australia	John Hunter Hospital	New Lambton Heights
Australia	Sydney Adventist Hospital	Wahroonga	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Austria	Klinikum Klagenfurt am Wörthersee	Klagenfurt	Kärnten
Austria	Privatklinik Wehrle-Diakonissen	Salzburg
Austria	Klinik Landstraße - Krankenhaus Rudolfstiftung	Wien
Austria	Universitätsklinikum AKH Wien	Wien
Belgium	Epicura	Baudour
Belgium	Imeldaziekenhuis - St-Elisabethkliniek	Bonheiden
Belgium	AZ St-Lucas Campus St-Lucas	Gent
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	CHU de Liege | CHR Citadel - Department of Nephrology	Liege
Belgium	AZ Nikolaas Campus Sint-Niklaas	Sint-niklaas
Bulgaria	MHAT Sveti Ivan Rilski 2003	Dupnitsa
Bulgaria	MHAT Haskovo	Haskovo
Bulgaria	UMHAT Kanev AD	Ruse
Bulgaria	MHAT Shumen AD	Shumen
Bulgaria	Multiprofile Hospital for Active Treatment Hristo Botev AD	Vratsa
Czechia	Krajska Nemocnice Liberec	Liberec
Czechia	Fakultni nemocnice Ostrava	Ostrava
Czechia	Privamed s.r.o.	Plzen
Czechia	Fresenius Nephro Care s.r.o. - Sokolov	Sokolov
Greece	General Hospital of Arta	Arta
Greece	General Hospital of Athens LAIKO	Athens
Greece	HIPPOKRATION General Hospital of Athens	Athens
Greece	Ioannina University General Hospital	Ioannina
Greece	University General Hospital of Larissa	Larissa
Greece	General Hospital of Thessaloniki Papageorgiou	Thessaloniki
Greece	Hippokration General Hospital of Thessaloniki	Thessaloniki
Hungary	Bajai Szent Rokus Korhaz	Baja
Hungary	Eszak-Pesti Centrumkorhaz-Honvedkorhaz	Budapest
Hungary	Fresenius Medical Care Egeszsegugyi Kft.	Budapest
Hungary	Csongrad Megyei Egeszsegugyi Ellato Kozpont,Hodmezovasarhely	Hodmezovasarhely
Hungary	Keszthelyi Korhaz	Keszthely
Hungary	Fresenius Medical Care Egeszsegugyi Kft.	Miskolc
Hungary	Fresenius Medical Care Egeszsegugyi Kft.	Pecs
Israel	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	Petach 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)	Zerifin
Italy	A.O.U. di Bologna Policlinico S.Orsola Malpighi	Bologna	Emilia-Romagna
Italy	A.O.U. Careggi	Firenze	Toscana
Italy	IRCCS Ospedale Policlinico San Martino	Genova	Liguria
Italy	A.O.U. di Parma	Parma	Emilia-Romagna
Italy	IRCCS Istituti Clinici Scientifici Maugeri SpA SB	Pavia	Lombardia
Italy	AUSL-IRCCS di Reggio Emilia	Reggio Emilia	Emilia-Romagna
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Lazio
Japan	Takemura Medical Nephro Clinic	Kanuma	Tochigi
Japan	Saiyu Clinic	Koshigaya	Saitama
Japan	Akebono Clinic	Kumamoto
Japan	Kyoto Station Takeda Dialysis Clinic	Kyoto
Japan	Nagaoka Red Cross Hospital	Nagaoka	Niigata
Japan	Akagaki Clinic	Osaka
Japan	Ibaraki Seinan Medical Center Hospital	Sashima-gun	Ibaraki
Japan	Futakotamagawaekimae clinic	Setagaya-ku	Tokyo
Japan	Katta General Hospital	Shiraishi	Miyagi
Japan	Ohishi Naika Clinic	Tsuchiura	Ibaraki
Japan	Tsuchiura Beryl Clinic	Tsuchiura	Ibaraki
Japan	Kikuchi Medical Clinic	Tsukuba	Ibaraki
Japan	Saint Hill Hospital	Ube	Yamaguchi
Japan	Yabuki Hospital	Yamagata
Lithuania	LUHS Kauno Hospital (Josvainiu str.)	Kaunas
Netherlands	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
Poland	Wojewodzki Szpital Zespolony	Kielce
Poland	Stacja Dializ Olkusz	Olkusz
Poland	NZOZ Nowy Szpital w Swieciu Sp. z o.o.	Swiecie
Poland	Stacja Dializ W-wa Mangalia	Warszawa
Poland	Stacja Dializ Zyrardow	Zyrardow
Portugal	SPD - Amadora (Diaverum Amadora)	Amadora	Lisboa
Portugal	Diaverum Aveiro	Aveiro
Portugal	Caledial - Centro de Hemodialise de Gaia	Canelas	Porto
Portugal	CHLO - Hospital Santa Cruz	Carnaxide	Lisboa
Portugal	Pluribus Dialise - Cascais (DaVita)	Cascais	Lisboa
Portugal	Eurodial Obidos (DaVita)	Gaeiras - Obidos	Leiria
Portugal	Eurodial Leiria (DaVita)	Leiria
Portugal	NephroCare APDP	Lisboa
Portugal	Pluribus Dialise - Sacavem (DaVita)	Sacavem	Lisboa
Portugal	Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department	Torres Novas	Santarém
Russian Federation	Chelyabinsk Regional Clinical Hospital	Chelyabinsk
Russian Federation	LLC Dialysis center	Kolomna
Russian Federation	LLC Fresenius medical care Kuban	Krasnodar
Russian Federation	LLC Dialysis center	Mytishchi
Russian Federation	City Clinical Hospital #1 Orenburg	Orenburg
Russian Federation	Republican Hospital n.a. V.A. Baranov	Petrozavodsk
Russian Federation	City Hospital #31	St. Petersburg
Russian Federation	Kupchinsky center for outpatient dialysis	St. Petersburg
Russian Federation	LLC B. Brown Avitum Russland Clinics	St. Petersburg
Russian Federation	LLC Yaroslavl dialysis center	Yaroslavl
Russian Federation	Sverdlovsk Regional Clinical Hospital #1	Yekaterinburg
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinico Universitario San Carlos | Nefrologia	Madrid
Spain	Hospital Althaia, Xarxa Assistencial de Manresa	Manresa	Barcelona
Spain	Corporació Sanitària Parc Taulí	Sabadell	Barcelona
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostela	A Coruña
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitario Dr. Peset	Valencia
Turkey	Hacettepe Universitesi Tip Fakultesi	Ankara
Turkey	Adnan Menderes Universitesi Tip fakultesi	Aydin
Turkey	Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi	Istanbul
Turkey	Turk Bobrek Vakfi Memorial Hizmet Hastanesi	Istanbul
Turkey	Erciyes Universitesi Tip Fakultesi	Kayseri
Turkey	Kocaeli Universitesi Tip Fakultesi	Kocaeli
Turkey	Inonu Universitesi Tip Fakultesi	Malatya
Ukraine	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	Uzhgorod
Ukraine	Vinnitsa Regional Clinical Hospital im. N.I. Pirogov	Vinnytsia
Ukraine	Zaporizhzhia Regional Clinical Hospital	Zaporizhzhya
United States	Renal Medicine Associates	Albuquerque	New Mexico
United States	ARA Augusta	Augusta	Georgia
United States	Fresenius North Austin Dialysis Center	Austin	Texas
United States	Waterloo Dialysis	Austin	Texas
United States	North America Research Institute - Azusa	Azusa	California
United States	Fresenius Kidney Care Baton Rouge Mancuso Lane	Baton Rouge	Louisiana
United States	Fresenius Kidney Care - Brawley	Brawley	California
United States	Liberty Dialysis- Caldwell	Caldwell	Idaho
United States	Durham Nephrology Associates, Pa	Durham	North Carolina
United States	ARA Plantation Dialysis, LLC	Ellenton	Florida
United States	DaVita South Valley Dialysis	Encino	California
United States	Fresenius Kidney Care Evergreen Park	Evergreen Park	Illinois
United States	DaVita Butler Farm Dialysis	Hampton	Virginia
United States	ARA Holyoke Dialysis Center	Holyoke	Massachusetts
United States	Fresenius Kidney Care - Mission Bend (FMCNA #3971)	Houston	Texas
United States	Davita Hospital Hill Dialysis	Kansas City	Missouri
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	Liberty Dialysis St. George	Saint George	Utah
United States	FMC San Ysidro	San Diego	California
United States	Fresenius Kidney Care Kearny Mesa	San Diego	California
United States	Fresenius Kidney Care South Dialysis	Shreveport	Louisiana
United States	Fresenius Kidney Care Sugar Land	Sugar Land	Texas
United States	DaVita Greater Waterbury Dialysis	Waterbury	Connecticut
United States	Queen's Dialysis Unit	West Covina	California

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Czechia,  Greece,  Hungary,  Israel,  Italy,  Japan,  Lithuania,  Netherlands,  Poland,  Portugal,  Russian Federation,  Spain,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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).	At 6 months (Visit 19 / Day 30 of the 6th month)
Secondary	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.	At 6 months (Visit 19 / Day 30 of the 6th month)

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