End-stage Renal Disease (ESRD) Pilot Study

NCT03787368 | Completed Phase 1 FDA Drug

• 2 other identifiers: 200462018-003109-24
• Study Type: interventional
• Target: 55
• Locations: 4 countries
• Sites: 15

Brief Summary

The purpose of this study is to investigate the safety of two different doses of a drug called BAY1213790 and how well it is tolerated in patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD). Approximately 40, with up to 60 study patients will take part in the study.

Conditions

Renal Dialysis

Keywords

End-stage renal disease patients undergoing hemodialysis

Outcome Measures

Primary Outcomes (2)

• Number of major and CRNM bleeding events

  CRNM bleeding: Clinically Relevant Non-Major bleeding

  Approx. 4 weeks (Before study drug or placebo administration)

• Number of major and CRNM bleeding events

  Approx. 4 weeks (After study drug or placebo administration)

Secondary Outcomes (3)

• AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC)

  Approx. 5 months (Pre-dose to follow up)

• aPTT will be measured via the kaolin-trigger method (clotting assay)

  Approx. 6 months (Before study drug or placebo administration to follow up)

• Factor XI activity will be assessed with an aPTT-based coagulation test using FXI

  Approx. 6 months (Before study drug or placebo administration to follow up)

Study Arms (3)

Dose 1 of BAY1213790

EXPERIMENTAL

Single intravenous infusion BAY1213790 (Dose 1)

Drug: BAY1213790

Dose 2 of BAY1213790

EXPERIMENTAL

Single intravenous infusion BAY1213790 (Dose 2)

Drug: BAY1213790

Placebo

PLACEBO COMPARATOR

Single intravenous infusion placebo

Drug: 0.9% sodium chloride solution

Interventions

BAY1213790 DRUG

Single intravenous infusion of BAY1213790 (Two different doses)

Dose 1 of BAY1213790; Dose 2 of BAY1213790

0.9% sodium chloride solution DRUG

Single intravenous infusion of Placebo (0.9% sodium chloride solution)

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients between 18 and 80 years of age.
• ESRD on hemodialysis (including hemodiafiltration) for at least 3 months
• Life expectancy of \> 6 months
• Women of non-childbearing potential

You may not qualify if:

• High risk for clinically significant bleeding
• Acute renal failure
• Planned major surgery in the next 7 months from randomization
• Concomitant use of oral anticoagulant therapy or antiplatelet therapy
• Documented thrombotic event in the past 6 months

Sponsors & Collaborators

• Bayer: lead

Study Sites (15)

California Institute of Renal Research - Chula Vista

Chula Vista, California, 91910, United States

Location

Nova Clinical Research, LLC

Bradenton, Florida, 34209, United States

Location

Research by Design, LLC

Chicago, Illinois, 60643, United States

Location

Renal and Transplant Associates of New England, PC

Springfield, Massachusetts, 01107, United States

Location

CHU de Charleroi Hôpital civil

Lodelinsart, Hainaut, 6042, Belgium

Location

UZ Brussel

Bruxelles - Brussel, 1090, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

CHLO - Hospital Santa Cruz

Carnaxide, Lisbon District, 2795-53, Portugal

Location

Pluribus Dialise - Cascais (DaVita)

Cascais, Lisbon District, 2750-663, Portugal

Location

CHMT - Hospital Rainha Santa Isabel

Torres Novas, Santarém District, 2350-754, Portugal

Location

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitario Dr. Peset

Valencia, 46017, Spain

Location

MeSH Terms

Interventions

osocimab; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients, investigators, and all other site staff will remain blinded for the administered BAY1213790 or placebo, with the exception of the unblinded pharmacist or specifically dedicated site personnel.The sponsor will be not be blinded. Bioanalysis of plasma concentrations and PD parameters, as well as the evaluation of results will be performed in a non-blinded fashion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: December 26, 2018
• Study Start: January 31, 2019
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

BE (3); ES (5); PT (3); US (4)