Trial Outcomes & Findings for A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus. (NCT NCT03802617)
NCT ID: NCT03802617
Last Updated: 2025-12-05
Results Overview
The primary analysis was performed using an MMRM with change from baseline in the mean NRS score at each time point as an objective variable; treatment group, time point, and treatment group-by-time point interaction as fixed effects; baseline mean NRS score and dynamic allocation factors, presence of prior treatment with nalfurafine hydrochloride, and presence of specific signs or symptoms to be confirmed in the screening period, as covariates; and subject as a random effect. Looking back on the period between the time of awakening on the previous day of assessment and the time of awakening on the day of assessment (including sleeping hours) once daily, subjects will assess the NRS score for the most severe itching by themselves. The most severe itching within the day will be assessed in integer on a scale ranging from 0 to 10, where 0 represents no itching and 10 represents worst itching imaginable.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
247 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-12-05
Participant Flow
Of 311 participants who had been screened, 247 subjects were enrolled in this study and were randomly assigned to each study drugs. 225 subjects completed the study and 22 subjects discontinued the study.
Participant milestones
| Measure |
0.25 μg/kg Group
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 8.75 μg
* \>= 45.0 kg, \< 65.0 kg: 12.50 μg
* \>= 65.0 kg, \< 85.0 kg: 17.50 μg
* \>= 85.0 kg: 21.25 μg
|
0.5 μg/kg Group
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 17.5 μg
* \>= 45.0 kg, \< 65.0 kg: 25.0 μg
* \>= 65.0 kg, \< 85.0 kg: 35.0 μg
* \>= 85.0 kg: 42.5 μg
|
1.0 μg/kg Group
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 35.0 μg
* \>= 45.0 kg, \< 65.0 kg: 50.0 μg
* \>= 65.0 kg, \< 85.0 kg: 70.0 μg
* \>= 85.0 kg: 85.0 μg
|
Placebo Group
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
62
|
63
|
|
Overall Study
COMPLETED
|
59
|
53
|
54
|
59
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
8
|
4
|
Reasons for withdrawal
| Measure |
0.25 μg/kg Group
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 8.75 μg
* \>= 45.0 kg, \< 65.0 kg: 12.50 μg
* \>= 65.0 kg, \< 85.0 kg: 17.50 μg
* \>= 85.0 kg: 21.25 μg
|
0.5 μg/kg Group
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 17.5 μg
* \>= 45.0 kg, \< 65.0 kg: 25.0 μg
* \>= 65.0 kg, \< 85.0 kg: 35.0 μg
* \>= 85.0 kg: 42.5 μg
|
1.0 μg/kg Group
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 35.0 μg
* \>= 45.0 kg, \< 65.0 kg: 50.0 μg
* \>= 65.0 kg, \< 85.0 kg: 70.0 μg
* \>= 85.0 kg: 85.0 μg
|
Placebo Group
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
5
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
|
Overall Study
Four consecutive missed doses of the study drug
|
0
|
1
|
1
|
1
|
Baseline Characteristics
A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Baseline characteristics by cohort
| Measure |
0.25 μg/kg Group
n=61 Participants
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 8.75 μg
* \>= 45.0 kg, \< 65.0 kg: 12.50 μg
* \>= 65.0 kg, \< 85.0 kg: 17.50 μg
* \>= 85.0 kg: 21.25 μg
|
0.5 μg/kg Group
n=61 Participants
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 17.5 μg
* \>= 45.0 kg, \< 65.0 kg: 25.0 μg
* \>= 65.0 kg, \< 85.0 kg: 35.0 μg
* \>= 85.0 kg: 42.5 μg
|
1.0 μg/kg Group
n=61 Participants
The study drug will be injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 35.0 μg
* \>= 45.0 kg, \< 65.0 kg: 50.0 μg
* \>= 65.0 kg, \< 85.0 kg: 70.0 μg
* \>= 85.0 kg: 85.0 μg
|
Placebo Group
n=63 Participants
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total).
|
Total
n=246 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=37 Participants
|
25 Participants
n=37 Participants
|
29 Participants
n=74 Participants
|
30 Participants
n=267 Participants
|
107 Participants
n=272 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=37 Participants
|
36 Participants
n=37 Participants
|
32 Participants
n=74 Participants
|
33 Participants
n=267 Participants
|
139 Participants
n=272 Participants
|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 11.2 • n=37 Participants
|
65.6 years
STANDARD_DEVIATION 11.4 • n=37 Participants
|
64.4 years
STANDARD_DEVIATION 11.7 • n=74 Participants
|
64.1 years
STANDARD_DEVIATION 12.7 • n=267 Participants
|
64.5 years
STANDARD_DEVIATION 11.7 • n=272 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=37 Participants
|
16 Participants
n=37 Participants
|
14 Participants
n=74 Participants
|
20 Participants
n=267 Participants
|
61 Participants
n=272 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=37 Participants
|
45 Participants
n=37 Participants
|
47 Participants
n=74 Participants
|
43 Participants
n=267 Participants
|
185 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=37 Participants
|
61 Participants
n=37 Participants
|
61 Participants
n=74 Participants
|
63 Participants
n=267 Participants
|
246 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Asian
|
61 Participants
n=37 Participants
|
61 Participants
n=37 Participants
|
61 Participants
n=74 Participants
|
63 Participants
n=267 Participants
|
246 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Region of Enrollment
Japan
|
61 participants
n=37 Participants
|
61 participants
n=37 Participants
|
61 participants
n=74 Participants
|
63 participants
n=267 Participants
|
246 participants
n=272 Participants
|
|
Dry weight at the start of Sceening
|
61.25 kg
STANDARD_DEVIATION 13.86 • n=37 Participants
|
59.98 kg
STANDARD_DEVIATION 11.22 • n=37 Participants
|
62.85 kg
STANDARD_DEVIATION 13.39 • n=74 Participants
|
60.63 kg
STANDARD_DEVIATION 12.71 • n=267 Participants
|
61.17 kg
STANDARD_DEVIATION 12.80 • n=272 Participants
|
|
Hemodialysis History
|
7.0 years
STANDARD_DEVIATION 6.5 • n=37 Participants
|
6.7 years
STANDARD_DEVIATION 7.2 • n=37 Participants
|
7.7 years
STANDARD_DEVIATION 6.5 • n=74 Participants
|
6.8 years
STANDARD_DEVIATION 6.1 • n=267 Participants
|
7.1 years
STANDARD_DEVIATION 6.5 • n=272 Participants
|
|
Disease duration of Itch
|
3.7 years
STANDARD_DEVIATION 3.5 • n=37 Participants
|
4.5 years
STANDARD_DEVIATION 4.4 • n=37 Participants
|
4.8 years
STANDARD_DEVIATION 4.9 • n=74 Participants
|
4.3 years
STANDARD_DEVIATION 4.4 • n=267 Participants
|
4.3 years
STANDARD_DEVIATION 4.3 • n=272 Participants
|
|
Average NRS Score
|
6.35 points
STANDARD_DEVIATION 1.24 • n=37 Participants
|
6.83 points
STANDARD_DEVIATION 1.40 • n=37 Participants
|
6.47 points
STANDARD_DEVIATION 1.29 • n=74 Participants
|
6.53 points
STANDARD_DEVIATION 1.31 • n=267 Participants
|
6.55 points
STANDARD_DEVIATION 1.31 • n=272 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: One subject of 1.0 μg/kg group was excluded from FAS due to deviation from one of the inclusion criteria. So, there is a discrepancy between the number of subjects in "Participant flow" and in "Overall Number of Participants Analyzed".
The primary analysis was performed using an MMRM with change from baseline in the mean NRS score at each time point as an objective variable; treatment group, time point, and treatment group-by-time point interaction as fixed effects; baseline mean NRS score and dynamic allocation factors, presence of prior treatment with nalfurafine hydrochloride, and presence of specific signs or symptoms to be confirmed in the screening period, as covariates; and subject as a random effect. Looking back on the period between the time of awakening on the previous day of assessment and the time of awakening on the day of assessment (including sleeping hours) once daily, subjects will assess the NRS score for the most severe itching by themselves. The most severe itching within the day will be assessed in integer on a scale ranging from 0 to 10, where 0 represents no itching and 10 represents worst itching imaginable.
Outcome measures
| Measure |
0.25 μg/kg Group
n=61 Participants
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 8.75 μg
* \>= 45.0 kg, \< 65.0 kg: 12.50 μg
* \>= 65.0 kg, \< 85.0 kg: 17.50 μg
* \>= 85.0 kg: 21.25 μg
|
0.5 μg/kg Group
n=61 Participants
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 17.5 μg
* \>= 45.0 kg, \< 65.0 kg: 25.0 μg
* \>= 65.0 kg, \< 85.0 kg: 35.0 μg
* \>= 85.0 kg: 42.5 μg
|
1.0 μg/kg Group
n=61 Participants
The study drug will be injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 35.0 μg
* \>= 45.0 kg, \< 65.0 kg: 50.0 μg
* \>= 65.0 kg, \< 85.0 kg: 70.0 μg
* \>= 85.0 kg: 85.0 μg
|
Placebo Group
n=63 Participants
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total).
|
|---|---|---|---|---|
|
Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period
|
-2.97 points
Standard Error 0.29
|
-3.65 points
Standard Error 0.30
|
-3.64 points
Standard Error 0.30
|
-2.86 points
Standard Error 0.29
|
Adverse Events
0.25 μg/kg Group
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
0.5 μg/kg Group
Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths
1.0 μg/kg Group
Serious events: 5 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo Group
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.25 μg/kg Group
n=61 participants at risk
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 8.75 μg
* \>= 45.0 kg, \< 65.0 kg: 12.50 μg
* \>= 65.0 kg, \< 85.0 kg: 17.50 μg
* \>= 85.0 kg: 21.25 μg
|
0.5 μg/kg Group
n=61 participants at risk
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 17.5 μg
* \>= 45.0 kg, \< 65.0 kg: 25.0 μg
* \>= 65.0 kg, \< 85.0 kg: 35.0 μg
* \>= 85.0 kg: 42.5 μg
|
1.0 μg/kg Group
n=62 participants at risk
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 35.0 μg
* \>= 45.0 kg, \< 65.0 kg: 50.0 μg
* \>= 65.0 kg, \< 85.0 kg: 70.0 μg
* \>= 85.0 kg: 85.0 μg
|
Placebo Group
n=63 participants at risk
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total).
|
|---|---|---|---|---|
|
Infections and infestations
Device related infection
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/61 • Number of events 1 • Up to 8 weeks
|
0.00%
0/62 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Infections and infestations
Gastroenteritis
|
1.6%
1/61 • Number of events 1 • Up to 8 weeks
|
0.00%
0/61 • Up to 8 weeks
|
0.00%
0/62 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/61 • Up to 8 weeks
|
0.00%
0/61 • Up to 8 weeks
|
0.00%
0/62 • Up to 8 weeks
|
1.6%
1/63 • Number of events 1 • Up to 8 weeks
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/61 • Number of events 1 • Up to 8 weeks
|
0.00%
0/62 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.00%
0/61 • Up to 8 weeks
|
0.00%
0/61 • Up to 8 weeks
|
0.00%
0/62 • Up to 8 weeks
|
1.6%
1/63 • Number of events 1 • Up to 8 weeks
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
1.6%
1/61 • Number of events 1 • Up to 8 weeks
|
0.00%
0/61 • Up to 8 weeks
|
0.00%
0/62 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/61 • Number of events 1 • Up to 8 weeks
|
1.6%
1/62 • Number of events 1 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/61 • Number of events 1 • Up to 8 weeks
|
0.00%
0/62 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/61 • Number of events 1 • Up to 8 weeks
|
0.00%
0/62 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/61 • Number of events 1 • Up to 8 weeks
|
0.00%
0/62 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/61 • Number of events 1 • Up to 8 weeks
|
0.00%
0/62 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/61 • Up to 8 weeks
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/62 • Number of events 1 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/61 • Up to 8 weeks
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/62 • Number of events 1 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/61 • Number of events 1 • Up to 8 weeks
|
0.00%
0/62 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/61 • Up to 8 weeks
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/62 • Number of events 1 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Cardiac disorders
Aortic valve stenosis
|
1.6%
1/61 • Number of events 1 • Up to 8 weeks
|
0.00%
0/61 • Up to 8 weeks
|
0.00%
0/62 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.00%
0/61 • Up to 8 weeks
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/62 • Number of events 1 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Eye disorders
Vitreous opacities
|
0.00%
0/61 • Up to 8 weeks
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/62 • Number of events 1 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/61 • Up to 8 weeks
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/62 • Number of events 1 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/61 • Up to 8 weeks
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/62 • Number of events 1 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/61 • Number of events 1 • Up to 8 weeks
|
0.00%
0/62 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
Other adverse events
| Measure |
0.25 μg/kg Group
n=61 participants at risk
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 8.75 μg
* \>= 45.0 kg, \< 65.0 kg: 12.50 μg
* \>= 65.0 kg, \< 85.0 kg: 17.50 μg
* \>= 85.0 kg: 21.25 μg
|
0.5 μg/kg Group
n=61 participants at risk
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 17.5 μg
* \>= 45.0 kg, \< 65.0 kg: 25.0 μg
* \>= 65.0 kg, \< 85.0 kg: 35.0 μg
* \>= 85.0 kg: 42.5 μg
|
1.0 μg/kg Group
n=62 participants at risk
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
* \< 45.0 kg: 35.0 μg
* \>= 45.0 kg, \< 65.0 kg: 50.0 μg
* \>= 65.0 kg, \< 85.0 kg: 70.0 μg
* \>= 85.0 kg: 85.0 μg
|
Placebo Group
n=63 participants at risk
The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total).
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
4.9%
3/61 • Number of events 3 • Up to 8 weeks
|
4.9%
3/61 • Number of events 3 • Up to 8 weeks
|
8.1%
5/62 • Number of events 5 • Up to 8 weeks
|
4.8%
3/63 • Number of events 4 • Up to 8 weeks
|
|
Nervous system disorders
Somnolence
|
3.3%
2/61 • Number of events 2 • Up to 8 weeks
|
4.9%
3/61 • Number of events 3 • Up to 8 weeks
|
9.7%
6/62 • Number of events 6 • Up to 8 weeks
|
4.8%
3/63 • Number of events 3 • Up to 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
3/61 • Number of events 3 • Up to 8 weeks
|
8.2%
5/61 • Number of events 7 • Up to 8 weeks
|
3.2%
2/62 • Number of events 2 • Up to 8 weeks
|
3.2%
2/63 • Number of events 2 • Up to 8 weeks
|
|
Gastrointestinal disorders
Constipation
|
8.2%
5/61 • Number of events 5 • Up to 8 weeks
|
4.9%
3/61 • Number of events 3 • Up to 8 weeks
|
11.3%
7/62 • Number of events 7 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/61 • Up to 8 weeks
|
1.6%
1/61 • Number of events 1 • Up to 8 weeks
|
6.5%
4/62 • Number of events 5 • Up to 8 weeks
|
1.6%
1/63 • Number of events 1 • Up to 8 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/61 • Number of events 1 • Up to 8 weeks
|
1.6%
1/61 • Number of events 1 • Up to 8 weeks
|
6.5%
4/62 • Number of events 5 • Up to 8 weeks
|
4.8%
3/63 • Number of events 3 • Up to 8 weeks
|
|
General disorders
Malaise
|
3.3%
2/61 • Number of events 2 • Up to 8 weeks
|
3.3%
2/61 • Number of events 2 • Up to 8 weeks
|
6.5%
4/62 • Number of events 5 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
General disorders
Pyrexia
|
3.3%
2/61 • Number of events 2 • Up to 8 weeks
|
6.6%
4/61 • Number of events 4 • Up to 8 weeks
|
0.00%
0/62 • Up to 8 weeks
|
0.00%
0/63 • Up to 8 weeks
|
|
Infections and infestations
Nasopharyngitis
|
13.1%
8/61 • Number of events 8 • Up to 8 weeks
|
9.8%
6/61 • Number of events 8 • Up to 8 weeks
|
4.8%
3/62 • Number of events 3 • Up to 8 weeks
|
11.1%
7/63 • Number of events 8 • Up to 8 weeks
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
6.6%
4/61 • Number of events 7 • Up to 8 weeks
|
4.9%
3/61 • Number of events 3 • Up to 8 weeks
|
3.2%
2/62 • Number of events 3 • Up to 8 weeks
|
4.8%
3/63 • Number of events 4 • Up to 8 weeks
|
|
Investigations
Blood pressure decreased
|
0.00%
0/61 • Up to 8 weeks
|
6.6%
4/61 • Number of events 4 • Up to 8 weeks
|
4.8%
3/62 • Number of events 3 • Up to 8 weeks
|
3.2%
2/63 • Number of events 2 • Up to 8 weeks
|
Additional Information
Clinical Development Division
Kissei Pharmaceutical Co., Ltd
Phone: Email olly
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place