Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745199
• Other study ID #: 4146
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2008
• Last updated: August 17, 2009
• Start date: May 2008
• Est. completion date: June 2009

Study information

• Verified date: August 2009
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Pruritus

Intervention

Drug:
• cromolyn sodium
oral cromolyn sodium, capsule 135mg, 1 capsule 3 times daily for 8 weeks
• placebo
capsule contains 135 mg lactose, 1 capsule 3 times daily for 8 weeks

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University of Medical sciences, Nemazi and Faghihi Hospital	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pruritus		3 months
Secondary	serum tryptase level		4 months