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Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus

Primary Purpose

End Stage Renal Disease, Pruritus

Status

Completed

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

cromolyn sodium

placebo

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring End Stage Renal Disease, Cromolyn Sodium, Pruritus, Tryptase

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Shiraz University of Medical sciences, Nemazi and Faghihi Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

Patients on hemodialysis with pruritus, receiving cromolyn sodium

patients on hemodialysis with pruritus, receiving placebo

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

Outcomes

Primary Outcome Measures

pruritus

Secondary Outcome Measures

serum tryptase level

Full Information

NCT ID

NCT00745199

First Posted

September 2, 2008

Last Updated

August 17, 2009

Sponsor

Shiraz University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00745199

Brief Title

Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease, Pruritus

Keywords

End Stage Renal Disease, Cromolyn Sodium, Pruritus, Tryptase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Patients on hemodialysis with pruritus, receiving cromolyn sodium

Arm Title

Arm Type

Experimental

Arm Description

patients on hemodialysis with pruritus, receiving placebo

Arm Title

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

cromolyn sodium

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

pruritus

Time Frame

3 months

Secondary Outcome Measure Information:

Title

serum tryptase level

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ghazal Vessal, PharmD, BCPS

Organizational Affiliation

Shiraz University of Medical Sciences

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mohammad Mahdi Sagheb, MD

Organizational Affiliation

Shiraz University of Medical Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Saman Shilian, Pharm student

Organizational Affiliation

Shiraz University of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shiraz University of Medical sciences, Nemazi and Faghihi Hospital

City

Shiraz

State/Province

Fars

ZIP/Postal Code

71345

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

33283264

Citation

Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.

Results Reference

derived

Learn more about this trial

Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus

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