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Multicenter, Randomized, Single-blind, Placebo-controlled, Combined 2-fold Cross-over and Group-comparison, Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Single Oral Doses of BAY85 3934 in Subjects With Chronic Kidney Disease (CKD)

Trial Profile

Multicenter, Randomized, Single-blind, Placebo-controlled, Combined 2-fold Cross-over and Group-comparison, Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Single Oral Doses of BAY85 3934 in Subjects With Chronic Kidney Disease (CKD)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 May 2016

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At a glance

  • Drugs Molidustat (Primary)
  • Indications Kidney disorders
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Bayer
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 29 Apr 2016 Time frame for primary endpoints changed. For adverse events time frame changed from 30 days to 9 weeks, and for blood pressure time frame changed from day 1 to 9 weeks.
    • 15 Mar 2014 New trial record
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