NCT00745199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 18, 2009

Status Verified

August 1, 2009

Enrollment Period

6 months

First QC Date

September 2, 2008

Last Update Submit

August 17, 2009

Conditions

End Stage Renal DiseasePruritus

Keywords

End Stage Renal DiseaseCromolyn SodiumPruritusTryptase

Outcome Measures

Primary Outcomes (1)

  • pruritus

    3 months

Secondary Outcomes (1)

  • serum tryptase level

    4 months

Study Arms (3)

1

EXPERIMENTAL

Patients on hemodialysis with pruritus, receiving cromolyn sodium

Drug: cromolyn sodium

2

EXPERIMENTAL

patients on hemodialysis with pruritus, receiving placebo

Drug: placebo

3

NO INTERVENTION

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

Interventions

cromolyn sodiumDRUG

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

1
placeboDRUG

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

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University of Medical sciences, Nemazi and Faghihi Hospital

Shiraz, Fars, 71345, Iran

Location

Related Publications (1)

  • 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.

    PMID: 33283264DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicPruritus

Interventions

Cromolyn Sodium

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ghazal Vessal, PharmD, BCPS

    Shiraz University of Medical Sciences

    STUDY DIRECTOR

  • Mohammad Mahdi Sagheb, MD

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Saman Shilian, Pharm student

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 3, 2008

Study Start

May 1, 2008

Primary Completion

November 1, 2008

Study Completion

June 1, 2009

Last Updated

August 18, 2009

Record last verified: 2009-08

Locations

IR(1)