NOX-100 for Preventing Hypotension During Hemodialysis
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety, tolerability and efficacy profile of NOX-100
      to reduce intradialytic hypotension (IDH) in patients undergoing chronic hemodialysis (HD).
    

Detailed description: 
      This is a 2-stage, prospective, randomized, double-blind, multi-dose, placebo-controlled,
      cross-over, phase IIa study to evaluate the safety, tolerability and efficacy profiles of
      NOX-100 to reduce the number of intradialytic hypotension episodes. At single-blind stage I,
      the eligible subject will receive a 1-week run-in period followed by a 1-week NOX-100
      treatment in a dose of 0.4mg/kg/hr. To evaluate the clearance of NOX-100, plasma levels of
      NOX-100 at the end of the 1st dialysis and prior to the 2nd dialysis will be measured. An
      interim analysis will be undertaken after the completion of first stage. The following
      process should be conducted only if the plasma level of NOX-100 decreases by 90% or more in
      these patients and all safety data have been reviewed by the medical monitor.

      At double blind stage II, patients will be randomized to one of the following treatment
      sequences in a 1:1 ratio.

        -  Sequence A: NOX-100 treatment phase followed by Placebo treatment phase

        -  Sequence B: Placebo treatment phase followed by NOX-100 treatment phase

      After a 1-week placebo, the subjects will receive the two 4-week treatment (sequence A or
      sequence B)which are separated by 1-week wash-out. In the NOX-100 treatment phase, subjects
      will subsequently receive NOX-100 in doses of 1.2, 2.5, 5, and 10 mg/kg/hr at the first three
      dialysis sessions over each week. In the placebo treatment phase, subjects will receive
      comparative placebo for four weeks. For the first 20 subjects, the treatment dose could be
      escalated only after the individual safety data have been reviewed by an unblinded medical
      monitor.

      To confirm if there is hepatic metabolism of NOX-100 between dialysis sessions, a
      pre-dialysis plasma level will be tested at the 2nd dialysis of Week 2, 5, 7 and 10 in the
      second stage.

      In both stages, the blood pressure will be measured pre-HD, every 30 minutes during HD and
      post-HD for monitoring the hypotension episode. For safety assessment, all AE(s), SAE(s) and
      any signs/symptoms during HD will be recorded. The safety of study drug will be followed
      until 4 weeks after last treatment.

      A Data and Safety Monitoring Board (DSMB) will be established prior to start of the trial and
      the DSMB meeting will be hold every 6~12 months during study period. Both medical monitor and
      DSMB will be responsible for safeguarding the interests of trial participants.
    

Intervention name(s): NOX-100
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: NOX-100