Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Pharmacokinetics of IV CR845 in Hemodialysis Patients, and Its Efficacy in Patients With Uremic Pruritus

NCT02229929

Pruritus Uremic Pruritus

COMPLETED PHASE2

Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

NCT02858726

Uremic Pruritus

COMPLETED PHASE2/PHASE3

CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

NCT03636269

Uremic Pruritus

COMPLETED PHASE3

A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

NCT03617536

Chronic Kidney Diseases Pruritus

COMPLETED PHASE2

A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

NCT05525234

Haemodialysis Uremic Pruritus Thalidomide

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End Stage Renal Disease Pruritus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Patients on hemodialysis with pruritus, receiving cromolyn sodium

Group Type EXPERIMENTAL

cromolyn sodium

Intervention Type DRUG

oral cromolyn sodium, capsule 135mg, 1 capsule 3 times daily for 8 weeks

2

patients on hemodialysis with pruritus, receiving placebo

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

capsule contains 135 mg lactose, 1 capsule 3 times daily for 8 weeks

3

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cromolyn sodium

oral cromolyn sodium, capsule 135mg, 1 capsule 3 times daily for 8 weeks

Intervention Type DRUG

placebo

capsule contains 135 mg lactose, 1 capsule 3 times daily for 8 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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