Trial Outcomes & Findings for Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus (NCT NCT02143973)
NCT ID: NCT02143973
Last Updated: 2025-05-21
Results Overview
The number of participants reporting at least one TEAE of a particular body system and preferred term are reported (incidence)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
167 participants
Primary outcome timeframe
24 weeks
Results posted on
2025-05-21
Participant Flow
Participant milestones
| Measure |
Nalbuphine HCl ER
nalbuphine HCl ER
nalbuphine HCl ER BID: nalbuphine HCl ER titrated from 30 mg QD to 120 mg BID over three weeks based on tolerability and efficacy, then maintain dosing at that maximum achieved level; full titration and maintenance is 24 weeks.
|
|---|---|
|
Overall Study
STARTED
|
167
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
66
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus
Baseline characteristics by cohort
| Measure |
Nalbuphine HCl ER
n=167 Participants
nalbuphine HCl ER
|
|---|---|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
136 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
146 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksThe number of participants reporting at least one TEAE of a particular body system and preferred term are reported (incidence)
Outcome measures
| Measure |
Nalbuphine HCl ER
n=167 Participants
nalbuphine HCl ER
|
|---|---|
|
Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs)
|
133 Participants
|
Adverse Events
Nalbuphine HCl ER
Serious events: 54 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nalbuphine HCl ER
n=167 participants at risk
nalbuphine HCl ER
|
|---|---|
|
Infections and infestations
Arteriovenous graft site infection
|
2.4%
4/167
|
|
Infections and infestations
Sepsis
|
1.8%
3/167
|
|
Infections and infestations
Diverticulitis
|
1.2%
2/167
|
|
Infections and infestations
Pneumonia
|
1.2%
2/167
|
|
Infections and infestations
Septic shock
|
1.2%
2/167
|
|
Infections and infestations
Abcess neck
|
0.60%
1/167
|
|
Infections and infestations
Arthritis bacterial
|
0.60%
1/167
|
|
Infections and infestations
Bronchitis bacterial
|
0.60%
1/167
|
|
Infections and infestations
Clostridium difficile infection
|
0.60%
1/167
|
|
Infections and infestations
Cystitis
|
0.60%
1/167
|
|
Infections and infestations
Endometritis
|
0.60%
1/167
|
|
Infections and infestations
Influenza
|
0.60%
1/167
|
|
Infections and infestations
Staphylococcal infection
|
0.60%
1/167
|
|
Infections and infestations
Urinary tract infection
|
0.60%
1/167
|
|
Infections and infestations
Urospesis
|
0.60%
1/167
|
|
Nervous system disorders
Syncope
|
1.2%
2/167
|
|
Nervous system disorders
Ataxia
|
0.60%
1/167
|
|
Nervous system disorders
Cerebrovascular accident
|
0.60%
1/167
|
|
Nervous system disorders
Convulsion
|
0.60%
1/167
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.60%
1/167
|
|
Nervous system disorders
Headache
|
0.60%
1/167
|
|
Nervous system disorders
Presyncope
|
0.60%
1/167
|
|
Nervous system disorders
Speech disorder
|
0.60%
1/167
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.4%
4/167
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.2%
2/167
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
2/167
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.60%
1/167
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.60%
1/167
|
|
Vascular disorders
Hypotension
|
1.8%
3/167
|
|
Vascular disorders
Hypertension
|
1.2%
2/167
|
|
Vascular disorders
Orthostatic hypotension
|
1.2%
2/167
|
|
Vascular disorders
Hypertensive emergency
|
0.60%
1/167
|
|
Vascular disorders
Jugular vein thrombosis
|
0.60%
1/167
|
|
Vascular disorders
Malignant hypertension
|
0.60%
1/167
|
|
Gastrointestinal disorders
Constipation
|
1.2%
2/167
|
|
Gastrointestinal disorders
Colitis
|
0.60%
1/167
|
|
Gastrointestinal disorders
Gastritis
|
0.60%
1/167
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.60%
1/167
|
|
Gastrointestinal disorders
Pancreatitis
|
0.60%
1/167
|
|
Gastrointestinal disorders
Proctitis
|
0.60%
1/167
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.60%
1/167
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.60%
1/167
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.60%
1/167
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site hemorrhage
|
0.60%
1/167
|
|
Injury, poisoning and procedural complications
Dialysis related complication
|
0.60%
1/167
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.60%
1/167
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.60%
1/167
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.60%
1/167
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.60%
1/167
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.60%
1/167
|
|
General disorders
Non-cardiac chest pain
|
2.4%
4/167
|
|
General disorders
Sudden cardiac death
|
0.60%
1/167
|
|
General disorders
Systemic inflammatory response syndrome
|
0.60%
1/167
|
|
Cardiac disorders
Cardiac arrest
|
0.60%
1/167
|
|
Cardiac disorders
Cardiac failure
|
0.60%
1/167
|
|
Cardiac disorders
Cardiac failure acute
|
0.60%
1/167
|
|
Cardiac disorders
Cardiac failure congestive
|
0.60%
1/167
|
|
Cardiac disorders
Myocardial infarction
|
0.60%
1/167
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.2%
2/167
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.60%
1/167
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.60%
1/167
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.2%
2/167
|
|
Hepatobiliary disorders
Cholangitis
|
0.60%
1/167
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.60%
1/167
|
|
Blood and lymphatic system disorders
Anaemia
|
0.60%
1/167
|
|
Endocrine disorders
Adrenal insufficiency
|
0.60%
1/167
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.60%
1/167
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.60%
1/167
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place