Sertraline Effect in Uremic Pruritis
Condition: Uremic Pruritis
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to assess the effect of sertraline on uremic pruritis in patients undergoing
      regular haemodialysis.
    

Detailed description: 
      The reported prevalence of uremic pruritus in adult hemodialysis patients has varied over the
      years, and some studies suggest the prevalence may be decreasing with more effective
      dialysis. One of the largest trials (the Dialysis Outcomes and Practice Patterns Study
      [DOPPS]) reported that the prevalence of moderate pruritus remained constant at 18 percent
      until 2015.

      A direct role for proinflammatory T cells and cytokines is suggested by studies that showed
      higher levels of proinflammatory T helper-1 (TH1) cells, C-reactive protein, interleukin-6,
      and interleukin-2 levels among hemodialysis patients versus those without pruritus. Also,
      histamine release from mast cells, other pruritogens and xerosis have been all implicated in
      the pathogenesis of uremic pruritus.

      Less convincing associations have also been made to anemia, male sex, increased beta-2
      microglobulin levels, serotype human leukocyte antigen (HLA)-B35, and comorbidities including
      congestive heart failure and neurologic disease. The risk of uremic pruritis appears to be
      independent of ethnicity, type of dialysis, and underlying renal disease. No single cause
      underlying uremic pruritus has been identified. Multiple factors have been associated in
      observational studies, and supportive therapies that are used to treat uremic pruritus have
      targeted such factors.

      High quality evidence on which to base recommendations for the treatment of uremic pruritus
      is limited. Many pharmacologic treatments have been proposed for uremic pruritis through
      different clinical trials. However, the results were quite variable and most of these studies
      were small uncontrolled trials and hence they were flawed.

      Several studies have revealed that the selective serotonin reuptake inhibitors (SSRI) could
      reduce the severity of pruritus. Sertraline hydrochloride is a selective serotonin reuptake
      inhibitor which established improvement in itching in patients with cholestatic pruritis.
      This was supported by Browning et al. (2003) whose study showed 86% of subjects who had been
      given sertraline for another indication improved considerably with pruritus disappearing in
      30% of the subjects.

      Generally, most of the previous research has tended to focus on cholestatic pruritis rather
      than uremic pruritis. Although enough is known to determine a reasonable approach to a
      patient with uremic pruritus, more research is needed to understand the pathophysiology of
      this condition and to establish more reliable treatments. Hence, this study is organized in
      an attempt to find out the effect of sertraline on alleviation of uremic pruritus.
    

Intervention name(s): sertraline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): sertraline at the intended dose of 50 mg twice daily for 8 weeks.; a placebo in the form of multivitamin tablets similar to the experimental drugs with the same regimen (one tablet /day for 8 weeks)
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This research is a double-blinded randomized multicentric clinical trial in which 50 haemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1.
Group A: 25 patients will receive sertraline at the intended dose of 50 mg twice daily for 8 weeks.
Group B: 25 patients will receive a placebo.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sertraline, hemodialysis