Refractory Uremic PruritisPhase 2NCT04660773
PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY UREAMIC PRURITIS
A Phase 2 study testing NB UVB phototherapy and Pregabalin in people with Refractory Uremic Pruritis, run by Alexandria University at 1 site in Egypt.
Trial summary
Patients will be randomly assigned into 2 groups: 1. Group A: (20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months. 2. Group B: (20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Refractory Uremic Pruritis
- What is being tested?
- NB UVB phototherapy and Pregabalin
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Mar 2022
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 20-60 years.
- End stage renal disease (the last stage(stage 5) of chronic disease which means kidneys are only functioning at 10 to 15 percent of their normal capacity and dialysis or kidney transplant is necessary to stay alive).
- Refractory uremic pruritis.
Who cannot join
- Other causes of pruritis (Dermatological or systemic) e.g. atopic, cholestatic liver disease.
- Photosensitivity.
- Contraindication or allergy to pregabalin.
- Patients on antipruritic drugs e.g. antihistamines, steroids, emollients, opioid agonists.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Alexandria, 21521
alexandria university faculty of medicine, 034862506, alexmed@edu.eg
About this study
Official title: NARROW BAND UVB PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY PRURITIS IN END STAGE RENAL DISEASE PATIENTS
Patients will be randomly assigned into 2 groups:
- Group A: (20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months.
- Group B: (20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months.
- Conditions
- Refractory Uremic Pruritis
- Being tested
- NB UVB phototherapy, Pregabalin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB UVB phototherapyDevice
ultraviolet phototherapy sessions
PregabalinDrug
oral medication
| Study group | Role | What they receive |
|---|---|---|
| NB UVB phototherapy | Active comparator | (20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months. Receives: Device: NB UVB phototherapy |
| pregabalin | Active comparator | 20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months. Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 D-itching scale
assessment of degree, duration, direction, disability and distribution of itching
Measured: two month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Aug 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Uremic PruritisStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa eldeeb, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660773
- Sponsor's protocol ID
- 0106476
- Status last verified
- Jul 2021
- First submitted
- 3 Dec 2020
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NARROW BAND UVB PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY PRURITIS IN END STAGE RENAL DISEASE PATIENTS
- ClinicalTrials.gov ID
- NCT04660773
- Acronym / sponsor ID
- 0106476
- Conditions
- Refractory Uremic Pruritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 9 Dec 2020 (actual)
- 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.
Patients will be randomly assigned into 2 groups:
- Group A: (20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months.
- Group B: (20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NB UVB phototherapy | Active comparator | Device: NB UVB phototherapy(20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months. |
| pregabalin | Active comparator | Drug: Pregabalin20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 20-60 years.
- End stage renal disease (the last stage(stage 5) of chronic disease which means kidneys are only functioning at 10 to 15 percent of their normal capacity and dialysis or kidney transplant is necessary to stay alive).
- Refractory uremic pruritis.
Key exclusion criteria (4 listed)
- Other causes of pruritis (Dermatological or systemic) e.g. atopic, cholestatic liver disease.
- Photosensitivity.
- Contraindication or allergy to pregabalin.
- Patients on antipruritic drugs e.g. antihistamines, steroids, emollients, opioid agonists.
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 |
|---|---|---|
| NB UVB phototherapyultraviolet phototherapy sessions | Device | NB UVB phototherapy |
| Pregabalinoral medication | Drug | pregabalin |
Primary outcome
5 D-itching scale
Time frame: two month
assessment of degree, duration, direction, disability and distribution of itching
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: No
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.
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 NB UVB phototherapy and Pregabalin in people with Refractory Uremic Pruritis, run by Alexandria University at 1 site in Egypt.
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 3 inclusion and 4 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 26 Jul 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact marwa eldeeb (01200029774, marwa.eldeeb16@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 D-itching scale (time frame: two month). It is what the study was designed to measure, not a finding.
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 26 Jul 2021.