Uremic PruritusSNUGNCT03576235
Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients
A study testing PG102P in people with Uremic Pruritus, run by Seoul National University Boramae Hospital at 1 site in South Korea.
Trial summary
In this study (SNUG trial), the investigators aim to investigate the anti-pruritic effect of PG102P in comparison with placebo in 80 patients undergoing HD. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Uremic Pruritus
- What is being tested?
- PG102P
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2018to 30 Mar 2019
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 19 years
- Patients with adequate HD (Kt/V > 1.2)
- Maintenance patients undergoing HD with chronic pruritus
- Mean visual analog scale (VAS) over 4 of the last 5 days in the 14-day pre-observation period
- Participants who allowed to continue the anti-pruritic drug treatment at the same dosage and administration schedule as used at baseline throughout the study period
- Patients who agreed to participate in this trial and had written an informed consent
Who cannot join
- Intact parathyroid hormone (iPTH) > 1000 pg/mL within 1 month
- Serum potassium > 7.0 mg/dL
- HIV Ab (+)
- Aspartate transaminase (AST) (glutamic oxaloacetic transaminase) or alanine transaminase (ALT) (glutamic pyruvic transaminase) > 3 times the upper limit of normal
- Scheduled to have kidney transplantation within 3 months
- Cancer history with current treatment
Show all 12Show fewer
- Active infection with current treatment
- Current itching with dermatologic diseases other than uremic pruritus
- Pregnancy, childbearing potential during the study period, or breastfeeding
- Allergy or hypersensitivity reaction to PG102P
- History of participating another clinical trial within 2 months or planning to participate another clinical trial
- Not eligible to participate this trial as researchers' decision
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Boramae Medical Center
Seoul, 07061
About this study
Official title: Safety and Efficacy of PG102P for the coNtrol of prUritus in Patients underGoing Hemodialysis (SNUG Trial): Study Protocol for a Randomized Control Trial
In this study (SNUG trial), the investigators aim to investigate the anti-pruritic effect of PG102P in comparison with placebo in 80 patients undergoing HD.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled trial in which one group will be treated with PG102P (1.5 g/day) and the other with a placebo. It is an investigator-initiated clinical trial. A superiority trial is planned to test the hypothesis that PG102P is effective in relieving pruritus for patients with ESRD undergoing HD.
- Conditions
- Uremic Pruritus
- Being tested
- PG102P, Placebo
- Keywords
- Uremic pruritus, Hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG102PDrug
Daily dose of 1.5g
PlaceboDrug
Daily dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| a treatment group | Experimental | PG102P 1.5 g/day Receives: Drug: PG102P |
| a control group | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS change from baseline
The primary endpoint is the change in VAS
Measured: the change in VAS between visit 2 (week 0) and visits 3, 4, 5, and 6 (weeks 2, 4, 8, 10)
Secondary outcomes (10)
serum total IgE
immunoglobulin E
Measured: week 0, week 8
blood Eosinophil count
Eosinophil count
Measured: week 0, week 8
serum ECP
Eosinophil Cationic Protein
Measured: week 0, week 8
serum Ca
serum Calcium
Measured: week 0, week 8
serum P
serum Phosphorus,
Measured: week 0, week 8
serum K
serum Potassium
Measured: week 0, week 8
serum iPTH
intact parathyroid hormone
Measured: week 0, week 8
Questionnaire #1 (KDQOL, Kidney Disease and Quality of Life)
The KDQOL-SF 1.3 includes 43 kidney disease targeted items as well as 36 items that provide a generic core and a overall health rating items (SF-36). The lowest and highest scores of each items are set at 0 to 100, with higher scores reflecting better quality of life.
- Kidney disease targeted (number of items) Symptoms/Problems (12), Effects of kidney disease (8), Burden of kidney disease (4), Work status (2), Cognitive function (3), Quality of social interaction (3), Sexual function (2), Sleep (4), Social support (2), Dialysis staff encouragement (2), Patient satisfaction rating (1), Overall heath rating (1)
- SF-36 (number of items)
Physical functioning (10), Role-physical (4), Bodily pain (2), General health (5), Mental health (5), Role-emotional (3), Social functioning (2), Vitality (4)
Measured: week 0, week 8
Questionnaire #2 (BDI, Beck's Depression Inventory)
The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Each answer is scored 0-3 with a maximum score of 63 points, and higher total scores indicate more severe depressive symptoms.
0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, 29-63: severe depression.
Measured: week 0, week 8
serum IL-31
inflammatory cytokine
Measured: week 0, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start1 May 2018
- Primary completion31 Jan 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uremic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Boramae Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Seoul National University Bundang Hospital, Ewha Womans University Mokdong Hospital, Severance Hospital, Chungnam National University Hospital, Gachon University Gil Medical Center, Kyungpook National University Hospital, DongGuk University
- Responsible party
- Principal investigator, Chun Soo Lim, Seoul National University Boramae Hospital
- Investigators
- Chun Soo Lim, MD, PhD, Principal investigator, Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576235
- Sponsor's protocol ID
- VM_PG102P
- Acronym
- SNUG
- Status last verified
- Sep 2019
- First submitted
- 21 Jun 2018
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 33283264Kim YC, Park JY, Oh S, Cho JH, Chang JH, Choi DE, Park JT, Lee JP, Kim S, Kim DK, Ryu DR, Lim CS. Safety and efficacy of PG102P for the control of pruritus in patients undergoing hemodialysis (SNUG trial): study protocol for a randomized controlled trial. Trials. 2019 Nov 28;20(1):651. doi: 10.1186/s13063-019-3753-1.
PubMed 31779697
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of PG102P for the coNtrol of prUritus in Patients underGoing Hemodialysis (SNUG Trial): Study Protocol for a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03576235
- Acronym / sponsor ID
- SNUG / VM_PG102P
- Conditions
- Uremic Pruritus
- Keywords
- Uremic pruritus, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University Boramae HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Seoul National University Bundang Hospital, Ewha Womans University Mokdong Hospital, Severance Hospital, Chungnam National University Hospital, Gachon University Gil Medical Center, Kyungpook National University Hospital, DongGuk University
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 3 Jul 2018 (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.
In this study (SNUG trial), the investigators aim to investigate the anti-pruritic effect of PG102P in comparison with placebo in 80 patients undergoing HD.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled trial in which one group will be treated with PG102P (1.5 g/day) and the other with a placebo. It is an investigator-initiated clinical trial. A superiority trial is planned to test the hypothesis that PG102P is effective in relieving pruritus for patients with ESRD undergoing HD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a treatment group | Experimental | Drug: PG102PPG102P 1.5 g/day |
| a control group | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 19 years
- Patients with adequate HD (Kt/V > 1.2)
- Maintenance patients undergoing HD with chronic pruritus
- Mean visual analog scale (VAS) over 4 of the last 5 days in the 14-day pre-observation period
- Participants who allowed to continue the anti-pruritic drug treatment at the same dosage and administration schedule as used at baseline throughout the study period
Key exclusion criteria (12 listed)
- Intact parathyroid hormone (iPTH) > 1000 pg/mL within 1 month
- Serum potassium > 7.0 mg/dL
- HIV Ab (+)
- Aspartate transaminase (AST) (glutamic oxaloacetic transaminase) or alanine transaminase (ALT) (glutamic pyruvic transaminase) > 3 times the upper limit of normal
- Scheduled to have kidney transplantation within 3 months
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 |
|---|---|---|
| PG102PDaily dose of 1.5g | Drug | a treatment group |
| PlaceboDaily dose of placebo | Drug | a control group |
Primary outcome
VAS change from baseline
Time frame: the change in VAS between visit 2 (week 0) and visits 3, 4, 5, and 6 (weeks 2, 4, 8, 10)
The primary endpoint is the change in VAS
10 secondary outcomes
serum total IgE
Time frame: week 0, week 8
blood Eosinophil count
Time frame: week 0, week 8
serum ECP
Time frame: week 0, week 8
serum Ca
Time frame: week 0, week 8
serum P
Time frame: week 0, week 8
serum K
Time frame: week 0, week 8
serum iPTH
Time frame: week 0, week 8
Questionnaire #1 (KDQOL, Kidney Disease and Quality of Life)
Time frame: week 0, week 8
Questionnaire #2 (BDI, Beck's Depression Inventory)
Time frame: week 0, week 8
serum IL-31
Time frame: week 0, week 8
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 19 Sep 2019.
- 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.
- Derived from this study: PubMed 31779697Kim YC, Park JY, Oh S, Cho JH, Chang JH, Choi DE, Park JT, Lee JP, Kim S, Kim DK, Ryu DR, Lim CS. Safety and efficacy of PG102P for the control of pruritus in patients undergoing hemodialysis (SNUG trial): study protocol for a randomized controlled trial. Trials. 2019 Nov 28;20(1):651. doi: 10.1186/s13063-019-3753-1.
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End-Stage Kidney Disease (ESKD), Hemodialysis
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.
Chun Soo Lim, MD, PhD principal investigator
Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PG102P in people with Uremic Pruritus, run by Seoul National University Boramae Hospital at 1 site in South Korea.
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 6 inclusion and 12 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 19 Sep 2019. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
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?
VAS change from baseline (time frame: the change in VAS between visit 2 (week 0) and visits 3, 4, 5, and 6 (weeks 2, 4, 8, 10)). 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 NCT03576235, which also lists 2 linked publications.
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 19 Sep 2019.