Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: End Stage Renal Disease; Pruritus

Treatments: Drug: placebo; Drug: cromolyn sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT00745199

4146

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

62 participants in 3 patient groups

1

Experimental group

Description:

Patients on hemodialysis with pruritus, receiving cromolyn sodium

Treatment:

Drug: cromolyn sodium

2

Experimental group

Description:

patients on hemodialysis with pruritus, receiving placebo

Treatment:

Drug: placebo

3

No Intervention group

Description:

Patients on hemodialysis but without pruritus who do not receive any treatment.