Clinical Trials List
Protocol NumberLT5001-101
2019-03-01 - 2020-12-31
Phase I
Terminated1
ICD-10N18.6
End stage renal disease
ICD-9585
Chronic renal failure
Clinical Pharmacology of LT5001 Drug Product in Hemodialysis Patients With Uremic Pruritus to Assess the Safety, Local Tolerance and Pharmacokinetics
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Trial Applicant
Lumosa Therapeutics Co., Ltd
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Sponsor
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Trial scale
Taiwan Single Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 王怡寬 Division of Nephrology
- 郭慧亮 Division of Nephrology
- Ping-Chin Lai Division of Nephrology
- 陳怡儒 Division of Nephrology
- 林信宏 Division of Nephrology
The Actual Total Number of Participants Enrolled
7 Terminated
Condition/Disease
Hemodialysis Patients With Uremic Pruritu
Objectives
Clinical Pharmacology of LT5001 Drug Product in Hemodialysis Patients With Uremic Pruritus to Assess the Safety, Local Tolerance and Pharmacokinetics
Test Drug
LT5001 drug product
Active Ingredient
Dosage Form
Dosage
1%
Endpoints
Part A:
Primary Endpoints
• Nature and severity of adverse events (AEs) and number of patients with AEs
Secondary Endpoints
• Systemic Ctrough exposure of LT5001 drug product (dinalbuphine sebacate and nalbuphine) in hemodialysis patients.
• Change in mean Worst Itching Intensity from baseline to the end of Week 4 using NRS.
• Reduction of itch intensity as assessed by the proportion of patients reduced NRS from baseline (≥ 2 points, ≥ 3 points, or ≥ 4 points) with respect to the weekly mean of the daily 24-hour Worst Itching Intensity NRS score from baseline to the end of Week 4.
• Improvement in itch-related quality of life as assessed by the change from baseline in 5-D Itch Scale score at the end of Week 4.
• Improvement in itch-related quality of life as assessed by the change from baseline in total Skindex-10 Scale score at the end of Week 4.
Part B:
Primary Endpoints
• Change from baseline to end of Week 8 in mean Worst Itching Intensity using NRS.
Secondary Endpoints
• Reduction of itch intensity as assessed by the proportion of patients reduced NRS from baseline with respect to the weekly mean of the daily 24-hour Worst Itching Intensity NRS score from baseline to end
of Week 8.
• Improvement in itch-related quality of life as assessed by the change from baseline in 5-D Itch Scale score to the end of Week 8.
• Improvement in itch-related quality of life as assessed by the change from baseline in total Skindex-10 Scale score at the end of Week 8.
• Nature and severity of adverse events (AEs) and number of patients with AEs.
Primary Endpoints
• Nature and severity of adverse events (AEs) and number of patients with AEs
Secondary Endpoints
• Systemic Ctrough exposure of LT5001 drug product (dinalbuphine sebacate and nalbuphine) in hemodialysis patients.
• Change in mean Worst Itching Intensity from baseline to the end of Week 4 using NRS.
• Reduction of itch intensity as assessed by the proportion of patients reduced NRS from baseline (≥ 2 points, ≥ 3 points, or ≥ 4 points) with respect to the weekly mean of the daily 24-hour Worst Itching Intensity NRS score from baseline to the end of Week 4.
• Improvement in itch-related quality of life as assessed by the change from baseline in 5-D Itch Scale score at the end of Week 4.
• Improvement in itch-related quality of life as assessed by the change from baseline in total Skindex-10 Scale score at the end of Week 4.
Part B:
Primary Endpoints
• Change from baseline to end of Week 8 in mean Worst Itching Intensity using NRS.
Secondary Endpoints
• Reduction of itch intensity as assessed by the proportion of patients reduced NRS from baseline with respect to the weekly mean of the daily 24-hour Worst Itching Intensity NRS score from baseline to end
of Week 8.
• Improvement in itch-related quality of life as assessed by the change from baseline in 5-D Itch Scale score to the end of Week 8.
• Improvement in itch-related quality of life as assessed by the change from baseline in total Skindex-10 Scale score at the end of Week 8.
• Nature and severity of adverse events (AEs) and number of patients with AEs.
Inclution Criteria
1. Male or female 20 to 75 years of age, inclusive, at the time of signing informed consent.
2. Patient must have been receiving in-center hemodialysis for ≥ 3 months and currently on a schedule of 3 times per week.
3. Patient must have had at least 2 urea reduction ratio (URR) measurements ≥ 65%, at least 2 single-pool Kt/V measurements ≥ 1.2, or 1 single-pool Kt/V measurement ≥ 1.2 and 1 URR measurement ≥
65% on different dialysis days within the last 3 month period prior to the Screening Visit.
4. Body weight ≥ 40 kg (not to exceed 115 kg) and BMI ≥ 18.0 and ≤ 31.0 kg/m2 at screening and Day 1 (after hemodialysis).
5. History of pruritus > 4 weeks of duration
6. Females with childbearing potential (defined as women ≤50 years of age with a history of amenorrhea for <12 months prior to study entry) must agree to use effective methods of contraception from screening through the last dose of study drug.
7. Males who are sexually active and whose partners are females of childbearing potential must agree to use condoms from screening through 90 days, whichever is longer, after administration of the last dose of study drug, and their partners must be willing to use a highly effective method of contraception from screening through 90 days after administration of the last dose of study drug.
8. Males must agree to not donate sperm from screening through 90 days, whichever is longer, after administration of the last dose of study drug.
9. Patient must have completed at least 6 days of Worst Itching Intensity NRS worksheets in the 7-day Diary run-in period and have a mean Worst Itching Intensity NRS score > 4 prior to randomization.
10. Patients must be able to read, complete questionnaires, understand the study procedures, and communicate effectively with the study personnel.
2. Patient must have been receiving in-center hemodialysis for ≥ 3 months and currently on a schedule of 3 times per week.
3. Patient must have had at least 2 urea reduction ratio (URR) measurements ≥ 65%, at least 2 single-pool Kt/V measurements ≥ 1.2, or 1 single-pool Kt/V measurement ≥ 1.2 and 1 URR measurement ≥
65% on different dialysis days within the last 3 month period prior to the Screening Visit.
4. Body weight ≥ 40 kg (not to exceed 115 kg) and BMI ≥ 18.0 and ≤ 31.0 kg/m2 at screening and Day 1 (after hemodialysis).
5. History of pruritus > 4 weeks of duration
6. Females with childbearing potential (defined as women ≤50 years of age with a history of amenorrhea for <12 months prior to study entry) must agree to use effective methods of contraception from screening through the last dose of study drug.
7. Males who are sexually active and whose partners are females of childbearing potential must agree to use condoms from screening through 90 days, whichever is longer, after administration of the last dose of study drug, and their partners must be willing to use a highly effective method of contraception from screening through 90 days after administration of the last dose of study drug.
8. Males must agree to not donate sperm from screening through 90 days, whichever is longer, after administration of the last dose of study drug.
9. Patient must have completed at least 6 days of Worst Itching Intensity NRS worksheets in the 7-day Diary run-in period and have a mean Worst Itching Intensity NRS score > 4 prior to randomization.
10. Patients must be able to read, complete questionnaires, understand the study procedures, and communicate effectively with the study personnel.
Exclusion Criteria
1. History of alcohol abuse, illicit drug use, physical dependence to any opioid or narcotic, or any history of drug abuse or addiction within 6 months of screening.
2. History of major surgery or trauma within 12 weeks of screening in the judgement of the investigator, or surgery planned during the study.
3. Has received ultraviolet B treatment, opioid antagonists (eg, naloxone, naltrexone), or opioid mixed agonist-antagonist (eg, nalbuphine) within 30 days prior to the Screening Visit or anticipated to receive such treatment during the study.
4. Has had a significant alteration in dialysis regimen within 2 weeks of the Screening Visit or anticipated to be receiving nocturnal dialysis, home hemodialysis treatment, or kidney transplant during the study.
5. Has any known history of allergic reaction to opioids.
6. History of latest positive serology test for HBV (HBsAg) or HCV (anti-HCV) within 1 year prior randomization consistent with current infection. Confirmatory tests will be allowed at the discretion of the investigator to rule out false positives.
7. Has any known history of HIV.
8. Positive pregnancy test or is lactating.
9. Has required peritoneal dialysis.
10. Alanine aminotransferase and/or aspartate aminotransferase concentration > 2 x the ULN, or total bilirubin > 1.8 x ULN, or hemoglobin concentration < 9 g/dL at the Screening Visit.
11. Has taken other investigational drugs or participated in any clinical study within 30 days or 5 half-lives (if known) of the investigational drug’s PK, PD, or biological activity (if known), whichever is longer, prior to first dose of study drug in this study or is currently participating in another clinical study.
12. Has received a vaccination within 3 days prior to administration of the first dose of study drug.
13. Has pruritus probably or definitely attributed to a cause other than renal disease or its complications such as atopic dermatitis, chronic urticarial, or hepatic pruritus caused by chronic liver disease.
14. Presence of skin infection (as defined by the investigator) on the area to be treated.
15. Any other condition or prior therapy that, in the investigator’s opinion, would make the patient unsuitable for the study, or unable or unwilling to comply with the study procedures
16. Involved in the planning or conduct of this study.
17. Unwilling or unlikely to comply with the requirements of the study.
2. History of major surgery or trauma within 12 weeks of screening in the judgement of the investigator, or surgery planned during the study.
3. Has received ultraviolet B treatment, opioid antagonists (eg, naloxone, naltrexone), or opioid mixed agonist-antagonist (eg, nalbuphine) within 30 days prior to the Screening Visit or anticipated to receive such treatment during the study.
4. Has had a significant alteration in dialysis regimen within 2 weeks of the Screening Visit or anticipated to be receiving nocturnal dialysis, home hemodialysis treatment, or kidney transplant during the study.
5. Has any known history of allergic reaction to opioids.
6. History of latest positive serology test for HBV (HBsAg) or HCV (anti-HCV) within 1 year prior randomization consistent with current infection. Confirmatory tests will be allowed at the discretion of the investigator to rule out false positives.
7. Has any known history of HIV.
8. Positive pregnancy test or is lactating.
9. Has required peritoneal dialysis.
10. Alanine aminotransferase and/or aspartate aminotransferase concentration > 2 x the ULN, or total bilirubin > 1.8 x ULN, or hemoglobin concentration < 9 g/dL at the Screening Visit.
11. Has taken other investigational drugs or participated in any clinical study within 30 days or 5 half-lives (if known) of the investigational drug’s PK, PD, or biological activity (if known), whichever is longer, prior to first dose of study drug in this study or is currently participating in another clinical study.
12. Has received a vaccination within 3 days prior to administration of the first dose of study drug.
13. Has pruritus probably or definitely attributed to a cause other than renal disease or its complications such as atopic dermatitis, chronic urticarial, or hepatic pruritus caused by chronic liver disease.
14. Presence of skin infection (as defined by the investigator) on the area to be treated.
15. Any other condition or prior therapy that, in the investigator’s opinion, would make the patient unsuitable for the study, or unable or unwilling to comply with the study procedures
16. Involved in the planning or conduct of this study.
17. Unwilling or unlikely to comply with the requirements of the study.
The Estimated Number of Participants
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Taiwan
18 participants
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Global
0 participants
