Official Title: “Phase II Study of the Effect of Oral Cromolyn Sodium on Uremic Pruritus and Serum Tryptase Levels of Hemodialysed Patients”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Patients on hemodialysis with pruritus, receiving cromolyn sodium
• Experimental: 2
  • patients on hemodialysis with pruritus, receiving placebo
• No Intervention: 3
  • Patients on hemodialysis but without pruritus who do not receive any treatment.

Primary Measures

• pruritus
  • Time Frame: 3 months
    Safety Issue?: No

Secondary Measures

• serum tryptase level
  • Time Frame: 4 months
    Safety Issue?: No

Inclusion Criteria:

• Hemodialysis patients > 18 yo suffering from pruritus for at least 6 weeks, and who have not responded to other drugs
• Willing and able to give informed concent

Exclusion Criteria:

• Known dermatologic, liver, metabolic disease, or any other disease or condition other than ESRD that causes pruritus
• Lactase deficiency

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Shiraz University of Medical Sciences

Overall Clinical Trial Officials and Contacts

Ghazal Vessal, PharmD, BCPS Study Director Shiraz University of Medical Sciences  

Overall Contact: Ghazal Vessal, PharmD, BCPS +98711-2424127 gvessal@sums.ac.ir

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00745199

Study ID Number: 4146

ClinicalTrials.gov Identifier: NCT00745199

Health Authority: Iran: Ethics Committee