End Stage Renal DiseasePhase 2NCT00745199
Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus
A Phase 2 study testing cromolyn sodium in people with End Stage Renal Disease and Pruritus, run by Shiraz University of Medical Sciences at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Disease, Pruritus
- What is being tested?
- cromolyn sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteIran
- Study dates
- May 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known dermatologic, liver, metabolic disease, or any other disease or condition other than ESRD that causes pruritus
- Lactase deficiency
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shiraz University of Medical sciences, Nemazi and Faghihi Hospital
Shiraz, Fars, 71345
About this study
Official title: Phase II Study of the Effect of Oral Cromolyn Sodium on Uremic Pruritus and Serum Tryptase Levels of Hemodialysed Patients
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.
- Conditions
- End Stage Renal Disease, Pruritus
- Being tested
- cromolyn sodium, placebo
- Keywords
- End Stage Renal Disease, Cromolyn Sodium, Pruritus, Tryptase
- Medical subject headings
- Kidney Failure, Chronic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cromolyn sodiumDrug
oral cromolyn sodium, capsule 135mg, 1 capsule 3 times daily for 8 weeks
placeboDrug
capsule contains 135 mg lactose, 1 capsule 3 times daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients on hemodialysis with pruritus, receiving cromolyn sodium Receives: Drug: cromolyn sodium |
| 2 | Experimental | patients on hemodialysis with pruritus, receiving placebo Receives: Drug: placebo |
| 3 | No intervention | Patients on hemodialysis but without pruritus who do not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pruritus
Measured: 3 months
Secondary outcomes (1)
serum tryptase level
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startMay 2008
- Primary completionNov 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Ghazal Vessal, PharmD, BCPS, Study director, Shiraz University of Medical SciencesMohammad Mahdi Sagheb, MD, Principal investigator, Shiraz University of Medical SciencesSaman Shilian, Pharm student, Principal investigator, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745199
- Sponsor's protocol ID
- 4146
- Status last verified
- Aug 2009
- First submitted
- 2 Sep 2008
- Last updated
- 18 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33283264
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Effect of Oral Cromolyn Sodium on Uremic Pruritus and Serum Tryptase Levels of Hemodialysed Patients
- ClinicalTrials.gov ID
- NCT00745199
- Acronym / sponsor ID
- 4146
- Conditions
- End Stage Renal Disease, Pruritus
- Keywords
- End Stage Renal Disease, Cromolyn Sodium, Pruritus, Tryptase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: cromolyn sodiumPatients on hemodialysis with pruritus, receiving cromolyn sodium |
| 2 | Experimental | Drug: placebopatients on hemodialysis with pruritus, receiving placebo |
| 3 | No intervention | –Patients on hemodialysis but without pruritus who do not receive any treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Known dermatologic, liver, metabolic disease, or any other disease or condition other than ESRD that causes pruritus
- Lactase deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cromolyn sodiumoral cromolyn sodium, capsule 135mg, 1 capsule 3 times daily for 8 weeks | Drug | 1 |
| placebocapsule contains 135 mg lactose, 1 capsule 3 times daily for 8 weeks | Drug | 2 |
Primary outcome
pruritus
Time frame: 3 months
1 secondary outcome
serum tryptase level
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2009.
- Derived from this study: PubMed 33283264Hercz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghazal Vessal, PharmD, BCPS study director
Shiraz University of Medical Sciences
Mohammad Mahdi Sagheb, MD principal investigator
Shiraz University of Medical Sciences
Saman Shilian, Pharm student principal investigator
Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cromolyn sodium in people with End Stage Renal Disease and Pruritus, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pruritus (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00745199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2009.