PruritusITCH RegistryNCT00715260
An Observational Study of Pruritus Amongst Hemodialysis Patients
An observational study of Pruritus and Kidney Failure, Chronic, run by Acologix, Inc. at 5 sites in United States.
Trial summary
The purpose of this observational study is to better understand the natural history/natural course of uremic pruritus (UP) - itching associated with chronic kidney disease(CKD). During the lifetime of a CKD dialysis patient, UP tends to be a prolonged, frequent, and an intense itch that is known to impair the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pruritus, Kidney Failure, Chronic, Hemodialysis
- How many people
- 80 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2007to Jul 2008
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on thrice-weekly (or more frequent) maintenance hemodialysis who have Uremic Pruritus
Who may be able to join
- Patients aged ≥ 18 years;
- Patients receiving chronic hemodialysis 3 or more times per week;
- Patients who have "mild", "moderate" or "severe" pruritus;
- "Mild" pruritus is defined as a nighttime or daytime worst itch intensity VAS >10 mm and < 40 mm at Screening and a combined daytime and nighttime Kawashima Itch Severity Score of < 2;
- "Moderate" pruritus is defined as a nighttime or daytime worst itch intensity VAS >10 mm and < 40 mm at Screening and a combined daytime and nighttime Kawashima Itch Severity Score of ≥ 3;
- "Severe" pruritus is defined as a nighttime or daytime worst itch intensity VAS of ≥ 40 mm at Screening and a combined daytime and nighttime Kawashima Itch Severity Score of ≥ 3;
- Patients who are able to understand and complete questionnaires written in English;
- Patients who are expected to continue to dialyze at the present dialysis unit for the duration of the study.
Who cannot join
- Patients who have pruritus attributed to causes other than chronic kidney disease (CKD) or the direct consequences of CKD (i.e., hyperparathyroidism, circulating "uremic toxins");
- Patients who have had significant alteration in their dialysis regimen within the 2 weeks prior to Screening (or those for whom such changes are anticipated during the study) are excluded. A "significant alteration" is defined as:
- A change in the type of hemodialysis filter;
- An increase or decrease in total duration of dialysis prescribed of > 1 hour/week;
- A change in the site or type of venous access for dialysis;
- An increase or decrease in prescribed blood flow of >100 mL/min;
- Patients who are unwilling to comply with the study protocol. Test Product, Dose, Mode of Administration and Duration of Treatment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Kidney Care Associates
Augusta, Georgia, 30901
Southeast Renal Associates
Charlotte, North Carolina, 28208
Nephrology Associates
Chattanooga, Tennessee, 37404
FMC Metaire
Metaire, Louisiana, 70006
Western New England Renal Associates
Springfield, Massachusetts, 01089
About this study
Official title: A Multicenter, Prospective, Observational Study of Pruritus Amongst Hemodialysis Patients: The ITCH National Registry
The purpose of this observational study is to better understand the natural history/natural course of uremic pruritus (UP) - itching associated with chronic kidney disease(CKD). During the lifetime of a CKD dialysis patient, UP tends to be a prolonged, frequent, and an intense itch that is known to impair the patient's quality of life (QoL), including sleep and mood.
The study will follow hemodialysis (HD) patients longitudinally to characterize their pruritus over time. The study will quantify and characterize UP and assess change over time; collect data on conditions that may be affected by UP such as sleep, mood, socialization and overall quality of life; collect data on use of medications, particularly anti-pruritic treatments, sleep aids, and medications for depression and anxiety; and collect data on medical resource use, particularly hospitalizations for treatment of skin and other infections over the duration of the study.
- Conditions
- Pruritus, Kidney Failure, Chronic, Hemodialysis, Chronic Disease
- Medical subject headings
- Pruritus, Kidney Failure, Chronic, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| UP Patients on HD | Uremic Pruritus (UP) patients maintained on hemodialysis (HD) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startDec 2007
- Primary completionJul 2008 (estimated)
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acologix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dawn McGuire, M.D., Study director, Acologix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715260
- Sponsor's protocol ID
- AC120-8002
- Acronym
- ITCH Registry
- Status last verified
- Jul 2008
- First submitted
- 8 Jul 2008
- Last updated
- 15 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational Study of Pruritus Amongst Hemodialysis Patients: The ITCH National Registry
- ClinicalTrials.gov ID
- NCT00715260
- Acronym / sponsor ID
- ITCH Registry / AC120-8002
- Conditions
- Pruritus, Kidney Failure, Chronic, Hemodialysis, Chronic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Acologix, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Jul 2008 (estimated)
- First posted
- 15 Jul 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.
The purpose of this observational study is to better understand the natural history/natural course of uremic pruritus (UP) - itching associated with chronic kidney disease(CKD). During the lifetime of a CKD dialysis patient, UP tends to be a prolonged, frequent, and an intense itch that is known to impair the patient's quality of life (QoL), including sleep and mood.
The study will follow hemodialysis (HD) patients longitudinally to characterize their pruritus over time. The study will quantify and characterize UP and assess change over time; collect data on conditions that may be affected by UP such as sleep, mood, socialization and overall quality of life; collect data on use of medications, particularly anti-pruritic treatments, sleep aids, and medications for depression and anxiety; and collect data on medical resource use, particularly hospitalizations for treatment of skin and other infections over the duration of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UP Patients on HD | – | –Uremic Pruritus (UP) patients maintained on hemodialysis (HD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on thrice-weekly (or more frequent) maintenance hemodialysis who have Uremic Pruritus
Key inclusion criteria (8 listed)
- Patients aged ≥ 18 years;
- Patients receiving chronic hemodialysis 3 or more times per week;
- Patients who have "mild", "moderate" or "severe" pruritus;
- Patients who are able to understand and complete questionnaires written in English;
- Patients who are expected to continue to dialyze at the present dialysis unit for the duration of the study.
Key exclusion criteria (7 listed)
- Patients who have pruritus attributed to causes other than chronic kidney disease (CKD) or the direct consequences of CKD (i.e., hyperparathyroidism, circulating "uremic toxins");
- Patients who have had significant alteration in their dialysis regimen within the 2 weeks prior to Screening (or those for whom such changes are anticipated during the study) are excluded. A "significant alteration" is defined as:
- Patients who are unwilling to comply with the study protocol. Test Product, Dose, Mode of Administration and Duration of Treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2008.
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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.
Dawn McGuire, M.D. study director
Acologix, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pruritus and Kidney Failure, Chronic, run by Acologix, Inc. at 5 sites in United States.
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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 15 Jul 2008.