End-stage Renal Disease (ESRD) Pilot Study
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/8/2019 |
| Start Date: | January 31, 2019 |
| End Date: | April 29, 2020 |
| Contact: | Bayer Clinical Trials Contact |
| Email: | clinical-trials-contact@bayer.com |
| Phone: | (+)1-888-84 22937 |
An Observer-blind, Multi-center, Placebo-controlled, Parallel Group Study to Assess the Safety and Tolerability and to Characterize the Pharmacokinetics and the Pharmacodynamics of Different Doses of BAY1213790 in Patients With End-stage Renal Disease Undergoing Hemodialysis
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.
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.
Inclusion Criteria
- 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
Exclusion Criteria:
- 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
We found this trial at
9
sites
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