NCT00745199

Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus

Phase II Study of the Effect of Oral Cromolyn Sodium on Uremic Pruritus and Serum Tryptase Levels of Hemodialysed Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Shiraz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Pruritus is a major disorder among the skin derangements in advanced renal failure. Recent information suggests that interactions between dermal mast cells and distal ends of nonmyelinated C fibers may be important in the precipitation and regulation of the sensory stimuli.Patients having uremic pruritus have been noted to have increased levels of plasma histamine and tryptase as well as increased numbers of dermal mast cells.Cromolyn sodium is a mast cell stabilizing agent that inhibits degranulation of mast cells and the release of histamine, tryptase, and leukotrienes. It is hypothesized that oral cromolyn sodium may attenuate uremic pruritus by decreasing serum tryptase level.

Conditions

• End Stage Renal Disease
• Pruritus

Interventions

Type	Name	Description
DRUG	cromolyn sodium	oral cromolyn sodium, capsule 135mg, 1 capsule 3 times daily for 8 weeks
DRUG	placebo	capsule contains 135 mg lactose, 1 capsule 3 times daily for 8 weeks

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-11-01
• Completion: 2009-06-01
• First posted: 2008-09-03
• Last updated: 2009-08-18

Locations

1 site across 1 country: Iran